Perinatal DepressionPhase 2NCT04051320

Characterizing the Neural Substrates of Irritability in Women: an Experimental Neuroendocrine Model

A Phase 2 study testing Leuprolide Acetate 3.75 MG/ML, Estradiol 2 Mg tablet and Micronized progesterone in people with Perinatal Depression and Post Partum Depression, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 22 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Perinatal Depression, Post Partum Depression, Depression, Postpartum
What is being tested?: Leuprolide Acetate 3.75 MG/ML, Estradiol 2 Mg tablet and Micronized progesterone
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 1 siteUnited States
Study dates: 2 Jan 2020to 19 Jul 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Participants will include healthy, euthymic 22-45 year old women with a history of postpartum depression (n=15) and women without such a history (n=15). Thus, only participants capable of giving informed consent will be enrolled. Participants will be compensated upon completion of the study.
Inclusion Criteria. Group 1: Women with a history of perinatal depression
A history of a the Diagnostic Statistic Manual of Mental Disorders - fifth edition (DSM-V) major depression episode that occurred within 6 weeks of childbirth (as determined by a SCID interview) and remitted at least one year prior to enrollment in the study;
has been well for a minimum of one year;
a regular menstrual cycle for at least three months;
age 22-45;

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medication free (including birth control pills);.
Group 2: Healthy Controls
Controls will meet all inclusion criteria specified above except they must not have any past or present Axis I diagnosis or evidence of menstrually related mood disorders.
A structured clinical interview for DSM-V (SCID) will be administered to all women prior to study entry. Any woman with a current axis I psychiatric diagnosis will be excluded from participating in this protocol.

Who cannot join

Patients will not be permitted to enter this protocol if they have important clinical or laboratory abnormalities including any of the following:
current axis I psychiatric diagnosis (based on a structured clinical interview for DSM-V (SCID);
endometriosis;
undiagnosed enlargement of the ovaries;
liver disease;
breast cancer;

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a history of blood clots in the legs or lungs;
undiagnosed vaginal bleeding;
porphyria;
diabetes mellitus;
malignant melanoma;
gallbladder or pancreatic disease;
heart or kidney disease;
cerebrovascular disease (stroke);
cigarette smoking;
a history of suicide attempts or psychotic episodes requiring hospitalization;
recurrent migraine with aura;
pregnancy-related medical conditions such as hyperemesis gravidarum, preeclampsia and toxemia, deep vein thrombosis (DVT) and bleeding diathesis;
Any woman with a first degree relative (immediate family) with premenopausal breast cancer or breast cancer presenting in both breasts or any woman who has multiple family members (greater than three relatives) with postmenopausal breast cancer will also be excluded from participating in this protocol;
Any woman meeting the Stages of Reproductive Aging Workshop Criteria (STRAW) for perimenopause will be excluded from participation. Specifically, the investigators will exclude any woman with an elevated plasma follicle stimulating hormone (FSH) level (> 14 IU/L) and with menstrual cycle variability of > 7 days different from their normal cycle length.
Pregnant women will be excluded from participation (patients will be warned not to become pregnant during the study and will be advised to employ barrier contraceptive methods), and women who become pregnant (although unlikely because of the hormone manipulation) will be withdrawn. The use of leuprolide acetate is not recommended during pregnancy. Prior to treatment, a complete physical, including a serum β-human chorionic gonadotropin (HCG) test for pregnancy. Participants will be seen at the outpatient clinic on a regular biweekly basis. All participants will be required to use non-hormonal forms of birth control (e.g., barrier methods) to avoid pregnancy during this study. Participants will also undergo urine toxicology and pregnancy tests on the day of each of the two fMRI scans. If a woman becomes pregnant during the study, she will not complete the fMRI scan, and the hormone protocol will be discontinued.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of North Carolina at Chapel Hill School of Medicine
Chapel Hill, North Carolina, 27514

Other trials in United States

About this study

The proposed study involves experimentally manipulating reproductive hormones in nonpregnant, euthymic women to create a scaled down version of the changes that occur during pregnancy and the postpartum period. This endocrine manipulation paradigm, which the investigators have shown provokes irritability in past studies, will be used to examine the neurocircuitry underlying irritability under baseline and hormone challenge conditions among women who are hormone sensitive (HS+; n=15) and non-hormone sensitive (HS-; n=15). The long-term goal of this research is to advance understanding of the neural systems underlying both the triggering of and susceptibility to irritability in women. The objective of the current project is to examine whether HS+ show differences in the behavioral activation system relative to HS- under baseline and hormone challenge conditions using functional magnetic resonance imaging (fMRI) and behavioral tests.

Read the detailed description

Irritability, defined as a predisposition to exhibit anger, is a prominent, defining symptom of perinatal depression (PND) and many other neuropsychiatric disorders. Despite the near ubiquity of irritability across disorders, the neural dysfunction underlying the vulnerability to, onset of, and exacerbation of irritability is understudied and poorly understood. The proposed study involves experimentally manipulating reproductive hormones in nonpregnant, euthymic women to create a scaled down version of the changes that occur during pregnancy and the postpartum period. This endocrine manipulation paradigm, which the investigators have shown provokes irritability in past studies, will be used to examine the neurocircuitry underlying irritability under baseline and hormone challenge conditions among women who are hormone sensitive (HS+; n=15) and non-hormone sensitive (HS-; n=15). The long-term goal of this research is to advance understanding of the neural systems underlying both the triggering of and susceptibility to irritability in women. The objective of the current project is to examine whether HS+ show differences in the behavioral activation system relative to HS- under baseline and hormone challenge conditions using functional magnetic resonance imaging (fMRI) and behavioral tests. The investigator's central hypothesis is that reproductive hormone changes are associated with dysregulated threat and reward processing and consequent irritability in HS+. The rationale for the proposed study is that employing a scaled down model of puerperal hormonal events permits the identification of a group of individuals homogeneous for hormone sensitivity (HS+), hence creating the best opportunity for disentangling the specific changes in brain function due to reproductive hormones (i.e., HS-) from those accompanying reproductive hormone-precipitated affective dysfunction (i.e., HS+). Because women will act as their own controls across time, this study design also allows for a powerful evaluation of state and trait variables that may contribute to irritability, including both threat and reward processing. Identifying both state and trait markers of irritability, and disentangling them from the effects of reproductive hormones on brain and behavior, will allow for the identification of neural substrates of irritability susceptibility that can be investigated across neuropsychiatric disorders. The expected outcome of this research is the identification of neural circuits underlying both the susceptibility to and mediation of irritability.

Conditions: Perinatal Depression, Post Partum Depression, Depression, Postpartum, Depression
Being tested: Leuprolide Acetate 3.75 MG/ML, Estradiol 2 Mg tablet, Micronized progesterone
Keywords: Irritability, Estrogen, Progesterone, Lupron Depot, Mood Disorders, Perinatal Depression, Postpartum, Hormones, Physiological effects of drugs, Reproductive Control Agents, Mental Disorders, Hormone Intervention, Functional Magnetic Resonance Imaging
Medical subject headings: Depression, Postpartum, Depression, Mood Disorders, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Leuprolide Acetate 3.75 MG/MLDrug
Also called Lupron
3.75 mg/month leuprolide acetate intramuscular injection
Estradiol 2 Mg tabletDrug
Also called Estrace
2 mg estradiol tablet
Micronized progesteroneDrug
Also called Prometrium
200 mg micronized progesterone tablets

Study groups in NCT04051320
Study group	Role	What they receive
Hormone Sensitive Women (HS+)	Experimental	Participants will take leuprolide acetate (lupron) via intramuscular injection, for 2 months. Participants will take 2 mg of estradiol twice daily and 200 mg of progesterone twice daily for 2 weeks. Receives: Drug: Leuprolide Acetate 3.75 MG/ML; Drug: Estradiol 2 Mg tablet; Drug: Micronized progesterone
Hormone Insensitive Women (HS-)	Experimental	Participants will take leuprolide acetate (lupron) via intramuscular injection, for 2 months. Participants will take 2 mg of estradiol twice daily and 200 mg of progesterone twice daily for 2 weeks. Receives: Drug: Leuprolide Acetate 3.75 MG/ML; Drug: Estradiol 2 Mg tablet; Drug: Micronized progesterone

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Threat Processing Bias During Visual Dot-probe Paradigm Over Time
This outcome measure determines the extent to which irritability is characterized by dysfunctional threat processing during reproductive hormone challenge relative to baseline in HS+ and HS- by examining threat attention bias assessed during the visual dot-probe paradigm.
The Visual Dot-Probe Paradigm asks participants to detect a target stimulus that is embedded in a matrix of distracting stimuli (e.g., a target stimulus, an angry face, might be embedded in a matrix of neutral distractor faces). Attention biases are inferred from faster response times to detect a threatening stimulus in a matrix of neutral stimuli relative to response time to detect neutral stimuli in neutral matrices. Thus, positive times reflect attention bias toward threat, whereas negative times reflect attention bias away from threat.
Measured: up to 6 weeks
Mean Right Amygdala-medial Prefrontal Cortex BOLD Connectivity During Implicit Emotion Face Processing Task Over Time
This outcome measure determines the extent to which irritability is characterized by dysfunctional threat processing during reproductive hormone challenge relative to baseline in HS+ and HS-. By examining amygdala-medial prefrontal cortex (PFC) Blood-oxygen-level-dependent (BOLD) connectivity in response to threatening faces on the implicit emotion face processing fMRI task in HS+ (compared with HS-) during hormone challenge relative to baseline.
The implicit emotion face processing task asks participants to identify the gender of angry, happy, and fearful faces at 50%, 100% and 150% emotion intensity presented in random order for 2000 milliseconds followed by jittered fixation. Trials appear in 3 blocks, generating 30 trials of each emotion at each intensity and 90 neutral face emotion trials.
Measured: up to 6 weeks
Mean Left Amygdala-medial Prefrontal Cortex BOLD Connectivity During Implicit Emotion Face Processing Task Over Time
This outcome measure determines the extent to which irritability is characterized by dysfunctional threat processing during reproductive hormone challenge relative to baseline in HS+ and HS-. By examining amygdala-medial prefrontal cortex (PFC) connectivity in response to threatening faces on the implicit emotion face processing fMRI task in HS+ (compared with HS-) during hormone challenge relative to baseline.
The implicit emotion face processing task asks participants to identify the gender of angry, happy, and fearful faces at 50%, 100% and 150% emotion intensity presented in random order for 2000 milliseconds followed by jittered fixation. Trials appear in 3 blocks, generating 30 trials of each emotion at each intensity and 90 neutral face emotion trials.
Measured: up to 6 weeks
Mean Reactive Aggression During Hormone Addback Over Time
This outcome measure determines the extent to which HS+ is characterized by reactive aggression during hormone addback relative to baseline in the target population. Reactive aggression will be defined as the number of point subtractions the participant makes during the Point Subtraction Aggression Paradigm.
Point Subtraction Aggression Paradigm measures relational aggression (approach behavior) in response to frustration. In the task, participants are asked to press a button to accrue money or press another button to subtract money from a (fictional) partner at no direct gain to themselves. Frustration is induced by periodic subtractions of their own money, which is attributed to the partner.
Measured: up to 6 weeks
Mean BOLD Activation of the Right Amygdala During the Affective Posner Task Over Time
This outcome measure determines the extent to which HS+ is characterized by BOLD activation of the right amygdala in response to frustrative non-reward (FNR) in the Affective Posner Task during hormone addback relative to baseline in the target population.
The Affective Posner Task tests whether HS+ is characterized by reduced subcortical activation in response to frustration. This task is divided into 3 runs: during Run 1 (practice run), participants receive accurate feedback about their performance on the task and do not win or lose money; during Run 2, participants receive accurate feedback about their performance and win or lose 50 cents per trial; and during Run 3 (frustration), participants are told they must respond accurately to win money, but participants are given feedback that they responded too slowly on 60% of accurate trials, regardless of their performance.
Measured: up to 6 weeks
Mean BOLD Activation of the Left Amygdala During the Affective Posner Task Over Time
This outcome measure determines the extent to which HS+ is characterized by BOLD activation of the left amygdala in response to frustrative non-reward (FNR) in the Affective Posner Task during hormone addback relative to baseline in the target population.
The Affective Posner Task tests whether HS+ is characterized by reduced subcortical activation in response to frustration. This task is divided into 3 runs: during Run 1 (practice run), participants receive accurate feedback about their performance on the task and do not win or lose money; during Run 2, participants receive accurate feedback about their performance and win or lose 50 cents per trial; and during Run 3 (frustration), participants are told they must respond accurately to win money, but participants are given feedback that they responded too slowly on 60% of accurate trials, regardless of their performance.
Measured: up to 6 weeks
Mean BOLD Activation of the Right Caudate During the Affective Posner Task Over Time
This outcome measure determines the extent to which HS+ is characterized by BOLD activation of the right caudate in response to frustrative non-reward (FNR) in the Affective Posner Task during hormone addback relative to baseline in the target population.
The Affective Posner Task tests whether HS+ is characterized by reduced subcortical activation in response to frustration. This task is divided into 3 runs: during Run 1 (practice run), participants receive accurate feedback about their performance on the task and do not win or lose money; during Run 2, participants receive accurate feedback about their performance and win or lose 50 cents per trial; and during Run 3 (frustration), participants are told they must respond accurately to win money, but participants are given feedback that they responded too slowly on 60% of accurate trials, regardless of their performance.
Measured: up to 6 weeks
Mean BOLD Activation of the Left Caudate During the Affective Posner Task Over Time
This outcome measure determines the extent to which HS+ is characterized by BOLD activation of the left caudate in response to frustrative non-reward (FNR) in the Affective Posner Task during hormone addback relative to baseline in the target population.
The Affective Posner Task tests whether HS+ is characterized by reduced subcortical activation in response to frustration. This task is divided into 3 runs: during Run 1 (practice run), participants receive accurate feedback about their performance on the task and do not win or lose money; during Run 2, participants receive accurate feedback about their performance and win or lose 50 cents per trial; and during Run 3 (frustration), participants are told they must respond accurately to win money, but participants are given feedback that they responded too slowly on 60% of accurate trials, regardless of their performance.
Measured: up to 6 weeks
Mean BOLD Activation of the Right Putamen During the Affective Posner Task Over Time
This outcome measure determines the extent to which HS+ is characterized by BOLD activation of the right putamen in response to frustrative non-reward (FNR) in the Affective Posner Task during hormone addback relative to baseline in the target population.
The Affective Posner Task tests whether HS+ is characterized by reduced subcortical activation in response to frustration. This task is divided into 3 runs: during Run 1 (practice run), participants receive accurate feedback about their performance on the task and do not win or lose money; during Run 2, participants receive accurate feedback about their performance and win or lose 50 cents per trial; and during Run 3 (frustration), participants are told they must respond accurately to win money, but participants are given feedback that they responded too slowly on 60% of accurate trials, regardless of their performance.
Measured: up to 6 weeks
Mean BOLD Activation of the Left Putamen During the Affective Posner Task Over Time
This outcome measure determines the extent to which HS+ is characterized by BOLD activation of the left putamen in response to frustrative non-reward (FNR) in the Affective Posner Task during hormone addback relative to baseline in the target population.
The Affective Posner Task tests whether HS+ is characterized by reduced subcortical activation in response to frustration. This task is divided into 3 runs: during Run 1 (practice run), participants receive accurate feedback about their performance on the task and do not win or lose money; during Run 2, participants receive accurate feedback about their performance and win or lose 50 cents per trial; and during Run 3 (frustration), participants are told they must respond accurately to win money, but participants are given feedback that they responded too slowly on 60% of accurate trials, regardless of their performance.
Measured: up to 6 weeks
Mean BOLD Activation of the Right Nucleus Accumbens During the Affective Posner Task Over Time
This outcome measure determines the extent to which HS+ is characterized by BOLD activation of the right nucleus accumbens in response to frustrative non-reward (FNR) in the Affective Posner Task during hormone addback relative to baseline in the target population.
The Affective Posner Task tests whether HS+ is characterized by reduced subcortical activation in response to frustration. This task is divided into 3 runs: during Run 1 (practice run), participants receive accurate feedback about their performance on the task and do not win or lose money; during Run 2, participants receive accurate feedback about their performance and win or lose 50 cents per trial; and during Run 3 (frustration), participants are told they must respond accurately to win money, but participants are given feedback that they responded too slowly on 60% of accurate trials, regardless of their performance.
Measured: up to 6 weeks
Mean BOLD Activation of the Left Nucleus Accumbens During the Affective Posner Task Over Time
This outcome measure determines the extent to which HS+ is characterized by BOLD activation of the left nucleus accumbens in response to frustrative non-reward (FNR) in the Affective Posner Task during hormone addback relative to baseline in the target population.
The Affective Posner Task tests whether HS+ is characterized by reduced subcortical activation in response to frustration. This task is divided into 3 runs: during Run 1 (practice run), participants receive accurate feedback about their performance on the task and do not win or lose money; during Run 2, participants receive accurate feedback about their performance and win or lose 50 cents per trial; and during Run 3 (frustration), participants are told they must respond accurately to win money, but participants are given feedback that they responded too slowly on 60% of accurate trials, regardless of their performance.
Measured: up to 6 weeks

Secondary outcomes (5)

Correlation Between the Inventory of Depressive and Anxiety Symptoms (IDAS) Ill -0.8Scale and Threat Attention Bias
This outcome measure determines the extent to which irritability is characterized by dysfunctional reward processing during reproductive hormone challenge in HS+ and HS- by examining the correlation between the Inventory of Depressive and Anxiety Symptoms (IDAS) Ill Temper (i.e., irritability) Scale and threat attention bias.
Measured: Endpoint (week 6)
Correlation Between the Inventory of Depressive and Anxiety Symptoms (IDAS) Ill Temper Scale and Right Amygdala-medial Prefrontal Cortex (PFC) BOLD Connectivity.
This outcome measure determines the extent to which irritability is characterized by dysfunctional reward processing during reproductive hormone challenge in HS+ and HS- by examining the correlation between the IDAS Ill Temper (i.e., irritability) Scale and amygdala-medial PFC connectivity in HS+.
Measured: Endpoint (week 6)
Correlation Between the Inventory of Depressive and Anxiety Symptoms (IDAS) Ill Temper Scale and Left Amygdala-medial Prefrontal Cortex (PFC) BOLD Connectivity.
This outcome measure determines the extent to which irritability is characterized by dysfunctional reward processing during reproductive hormone challenge in HS+ and HS- by examining the correlation between the IDAS Ill Temper (i.e., irritability) Scale and amygdala-medial PFC connectivity in HS+.
Measured: Endpoint (week 6)
Correlation Between Irritability and Reactive Aggression During Hormone Addback
This outcome measure determines the degree of irritability and reactive aggression in HS+ during hormone addback and its relationship to the target population. Irritability will be defined as score on the IDAS Ill Temper Scale. Reactive aggression will be defined as the number of point subtractions the participant makes during the Point Subtraction Aggression Paradigm.
The Point Subtraction Aggression Paradigm measures relational aggression (approach behavior) in response to frustration. In the task, participants are asked to press a button to ac
Measured: Endpoint (week 6)
Correlation Between Irritability Subcortical Activation in HS+ During Hormone Addback
This outcome measure determines the degree of subcortical (amygdala, caudate, putamen, and nucleus accumbens) activation in HS+ during hormone addback and it's relationship to the target population. The activation in amygdala and ventral striatum (caudate, putamen, nucleus accumbens) regions of interest (ROIs) will be assessed during the Affective Posner Task.
The Affective Posner Task tests whether HS+ is characterized by reduced subcortical activation in response to frustration. This task is divided into 3 runs: during Run 1 (practice run), participants receive accurate feedback about their performance on the task and do not win or lose money; during Run 2, participants receive accurate feedback about their performance and win or lose 50 cents per trial; and during Run 3 (frustration), participants are told they must respond accurately to win money, but participants are given feedback that they responded too slowly on 60% of accurate trials, regardless of their performance.
Measured: Endpoint (week 6)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jan 202019 Jul 2022

First posted9 Aug 2019
Study start2 Jan 2020
Primary completion15 Jul 2022
Study completion19 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (107)Papers the sponsor has linked to this study.
Other trials for Perinatal DepressionStudies of the same condition, open and under way.
More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04051320
Sponsor's protocol ID: 19-0401
Other IDs: R21MH119615-01
Status last verified: May 2023
First submitted: 7 Aug 2019
Last updated: 25 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Deidentified individual data that supports the results will be shared beginning 18 to 24 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Publications

Vidal-Ribas P, Brotman MA, Valdivieso I, Leibenluft E, Stringaris A. The Status of Irritability in Psychiatry: A Conceptual and Quantitative Review. J Am Acad Child Adolesc Psychiatry. 2016 Jul;55(7):556-70. doi: 10.1016/j.jaac.2016.04.014. Epub 2016 May 6.
PubMed 27343883
American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders (DSM-5®). (American Psychiatric Pub, 2013).
Fava M, Hwang I, Rush AJ, Sampson N, Walters EE, Kessler RC. The importance of irritability as a symptom of major depressive disorder: results from the National Comorbidity Survey Replication. Mol Psychiatry. 2010 Aug;15(8):856-67. doi: 10.1038/mp.2009.20. Epub 2009 Mar 10.
PubMed 19274052
Perlis RH, Fraguas R, Fava M, Trivedi MH, Luther JF, Wisniewski SR, Rush AJ. Prevalence and clinical correlates of irritability in major depressive disorder: a preliminary report from the Sequenced Treatment Alternatives to Relieve Depression study. J Clin Psychiatry. 2005 Feb;66(2):159-66; quiz 147, 273-4.
PubMed 15705000
Leibenluft E, Cohen P, Gorrindo T, Brook JS, Pine DS. Chronic versus episodic irritability in youth: a community-based, longitudinal study of clinical and diagnostic associations. J Child Adolesc Psychopharmacol. 2006 Aug;16(4):456-66. doi: 10.1089/cap.2006.16.456.
PubMed 16958570
Price M, van Stolk-Cooke K. Examination of the interrelations between the factors of PTSD, major depression, and generalized anxiety disorder in a heterogeneous trauma-exposed sample using DSM 5 criteria. J Affect Disord. 2015 Nov 1;186:149-55. doi: 10.1016/j.jad.2015.06.012. Epub 2015 Jul 29.
PubMed 26241663
Van Voorhees EE, Dennis PA, Elbogen EB, Fuemmeler B, Neal LC, Calhoun PS, Beckham JC. Characterizing anger-related affect in individuals with posttraumatic stress disorder using ecological momentary assessment. Psychiatry Res. 2018 Mar;261:274-280. doi: 10.1016/j.psychres.2017.12.080. Epub 2018 Jan 3.
PubMed 29329048
Penn DL, Spaulding W, Reed D, Sullivan M. The relationship of social cognition to ward behavior in chronic schizophrenia. Schizophr Res. 1996 Jul 5;20(3):327-35. doi: 10.1016/0920-9964(96)00010-2.
PubMed 8827860
Bilgi MM, Taspinar S, Aksoy B, Oguz K, Coburn K, Gonul AS. The relationship between childhood trauma, emotion recognition, and irritability in schizophrenia patients. Psychiatry Res. 2017 May;251:90-96. doi: 10.1016/j.psychres.2017.01.091. Epub 2017 Feb 3.
PubMed 28192770
McGuire K, Fung LK, Hagopian L, Vasa RA, Mahajan R, Bernal P, Silberman AE, Wolfe A, Coury DL, Hardan AY, Veenstra-VanderWeele J, Whitaker AH. Irritability and Problem Behavior in Autism Spectrum Disorder: A Practice Pathway for Pediatric Primary Care. Pediatrics. 2016 Feb;137 Suppl 2:S136-48. doi: 10.1542/peds.2015-2851L. Epub 2016 Feb 1.
PubMed 26908469
Alper KR, Barry JJ, Balabanov AJ. Treatment of psychosis, aggression, and irritability in patients with epilepsy. Epilepsy Behav. 2002 Oct;3(5S):13-18. doi: 10.1016/s1525-5069(02)00500-5.
PubMed 12609315
Lopez OL, Becker JT, Sweet RA, Klunk W, Kaufer DI, Saxton J, Habeych M, DeKosky ST. Psychiatric symptoms vary with the severity of dementia in probable Alzheimer's disease. J Neuropsychiatry Clin Neurosci. 2003 Summer;15(3):346-53. doi: 10.1176/jnp.15.3.346.
PubMed 12928511
Scott LN, Stepp SD, Hallquist MN, Whalen DJ, Wright AGC, Pilkonis PA. Daily shame and hostile irritability in adolescent girls with borderline personality disorder symptoms. Personal Disord. 2015 Jan;6(1):53-63. doi: 10.1037/per0000107.
PubMed 25580673
Leibenluft E. Pediatric Irritability: A Systems Neuroscience Approach. Trends Cogn Sci. 2017 Apr;21(4):277-289. doi: 10.1016/j.tics.2017.02.002. Epub 2017 Mar 6.
PubMed 28274677
Williamson JA, O'Hara MW, Stuart S, Hart KJ, Watson D. Assessment of postpartum depressive symptoms: the importance of somatic symptoms and irritability. Assessment. 2015 Jun;22(3):309-18. doi: 10.1177/1073191114544357. Epub 2014 Jul 24.
PubMed 25059681

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Characterizing the Neural Substrates of Irritability in Women: an Experimental Neuroendocrine Model
ClinicalTrials.gov ID: NCT04051320
Acronym / sponsor ID: 19-0401
Conditions: Perinatal Depression, Post Partum Depression, Depression, Postpartum, Depression
Keywords: Irritability, Estrogen, Progesterone, Lupron Depot, Mood Disorders, Perinatal Depression, Postpartum, Hormones
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 2 Jan 2020 (actual)
Primary completion: 15 Jul 2022 (actual)
Study completion: 19 Jul 2022 (actual)
First posted: 9 Aug 2019 (actual)
Results: Posted 25 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Hormone Sensitive Women (HS+)	Experimental	Drug: Leuprolide Acetate 3.75 MG/ML, Drug: Estradiol 2 Mg tablet, Drug: Micronized progesteroneParticipants will take leuprolide acetate (lupron) via intramuscular injection, for 2 months. Participants will take 2 mg of estradiol twice daily and 200 mg of progesterone twice daily for 2 weeks.
Hormone Insensitive Women (HS-)	Experimental	Drug: Leuprolide Acetate 3.75 MG/ML, Drug: Estradiol 2 Mg tablet, Drug: Micronized progesteroneParticipants will take leuprolide acetate (lupron) via intramuscular injection, for 2 months. Participants will take 2 mg of estradiol twice daily and 200 mg of progesterone twice daily for 2 weeks.

Who may qualify

Ages: 22 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Participants will include healthy, euthymic 22-45 year old women with a history of postpartum depression (n=15) and women without such a history (n=15). Thus, only participants capable of giving informed consent will be enrolled. Participants will be compensated upon completion of the study.
Inclusion Criteria. Group 1: Women with a history of perinatal depression
A history of a the Diagnostic Statistic Manual of Mental Disorders - fifth edition (DSM-V) major depression episode that occurred within 6 weeks of childbirth (as determined by a SCID interview) and remitted at least one year prior to enrollment in the study;
has been well for a minimum of one year;
a regular menstrual cycle for at least three months;

Key exclusion criteria (21 listed)

Patients will not be permitted to enter this protocol if they have important clinical or laboratory abnormalities including any of the following:
current axis I psychiatric diagnosis (based on a structured clinical interview for DSM-V (SCID);
endometriosis;
undiagnosed enlargement of the ovaries;
liver disease;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Leuprolide Acetate 3.75 MG/MLAlso: Lupron3.75 mg/month leuprolide acetate intramuscular injection	Drug	Hormone Insensitive Women (HS-), Hormone Sensitive Women (HS+)
Estradiol 2 Mg tabletAlso: Estrace2 mg estradiol tablet	Drug	Hormone Insensitive Women (HS-), Hormone Sensitive Women (HS+)
Micronized progesteroneAlso: Prometrium200 mg micronized progesterone tablets	Drug	Hormone Insensitive Women (HS-), Hormone Sensitive Women (HS+)

Primary outcome

Mean Threat Processing Bias During Visual Dot-probe Paradigm Over Time
Time frame: up to 6 weeks
This outcome measure determines the extent to which irritability is characterized by dysfunctional threat processing during reproductive hormone challenge relative to baseline in HS+ and HS- by examining threat attention bias assessed during the visual dot-probe paradigm. The Visual Dot-Probe Paradigm asks participants to detect a target stimulus that is embedded in a matrix of distracting stimuli (e.g., a target stimulus, an angry face, might be embedded in a matrix of neutral distractor faces). Attention biases are inferred from faster response times to detect a threatening stimulus in a matrix of neutral stimuli relative to response time to detect neutral stimuli in neutral matrices. Thus, positive times reflect attention bias toward threat, whereas negative times reflect attention bias away from threat.
Mean Right Amygdala-medial Prefrontal Cortex BOLD Connectivity During Implicit Emotion Face Processing Task Over Time
Time frame: up to 6 weeks
This outcome measure determines the extent to which irritability is characterized by dysfunctional threat processing during reproductive hormone challenge relative to baseline in HS+ and HS-. By examining amygdala-medial prefrontal cortex (PFC) Blood-oxygen-level-dependent (BOLD) connectivity in response to threatening faces on the implicit emotion face processing fMRI task in HS+ (compared with HS-) during hormone challenge relative to baseline. The implicit emotion face processing task asks participants to identify the gender of angry, happy, and fearful faces at 50%, 100% and 150% emotion intensity presented in random order for 2000 milliseconds followed by jittered fixation. Trials appear in 3 blocks, generating 30 trials of each emotion at each intensity and 90 neutral face emotion trials.
Mean Left Amygdala-medial Prefrontal Cortex BOLD Connectivity During Implicit Emotion Face Processing Task Over Time
Time frame: up to 6 weeks
This outcome measure determines the extent to which irritability is characterized by dysfunctional threat processing during reproductive hormone challenge relative to baseline in HS+ and HS-. By examining amygdala-medial prefrontal cortex (PFC) connectivity in response to threatening faces on the implicit emotion face processing fMRI task in HS+ (compared with HS-) during hormone challenge relative to baseline. The implicit emotion face processing task asks participants to identify the gender of angry, happy, and fearful faces at 50%, 100% and 150% emotion intensity presented in random order for 2000 milliseconds followed by jittered fixation. Trials appear in 3 blocks, generating 30 trials of each emotion at each intensity and 90 neutral face emotion trials.
Mean Reactive Aggression During Hormone Addback Over Time
Time frame: up to 6 weeks
This outcome measure determines the extent to which HS+ is characterized by reactive aggression during hormone addback relative to baseline in the target population. Reactive aggression will be defined as the number of point subtractions the participant makes during the Point Subtraction Aggression Paradigm. Point Subtraction Aggression Paradigm measures relational aggression (approach behavior) in response to frustration. In the task, participants are asked to press a button to accrue money or press another button to subtract money from a (fictional) partner at no direct gain to themselves. Frustration is induced by periodic subtractions of their own money, which is attributed to the partner.
Mean BOLD Activation of the Right Amygdala During the Affective Posner Task Over Time
Time frame: up to 6 weeks
This outcome measure determines the extent to which HS+ is characterized by BOLD activation of the right amygdala in response to frustrative non-reward (FNR) in the Affective Posner Task during hormone addback relative to baseline in the target population. The Affective Posner Task tests whether HS+ is characterized by reduced subcortical activation in response to frustration. This task is divided into 3 runs: during Run 1 (practice run), participants receive accurate feedback about their performance on the task and do not win or lose money; during Run 2, participants receive accurate feedback about their performance and win or lose 50 cents per trial; and during Run 3 (frustration), participants are told they must respond accurately to win money, but participants are given feedback that they responded too slowly on 60% of accurate trials, regardless of their performance.
Mean BOLD Activation of the Left Amygdala During the Affective Posner Task Over Time
Time frame: up to 6 weeks
This outcome measure determines the extent to which HS+ is characterized by BOLD activation of the left amygdala in response to frustrative non-reward (FNR) in the Affective Posner Task during hormone addback relative to baseline in the target population. The Affective Posner Task tests whether HS+ is characterized by reduced subcortical activation in response to frustration. This task is divided into 3 runs: during Run 1 (practice run), participants receive accurate feedback about their performance on the task and do not win or lose money; during Run 2, participants receive accurate feedback about their performance and win or lose 50 cents per trial; and during Run 3 (frustration), participants are told they must respond accurately to win money, but participants are given feedback that they responded too slowly on 60% of accurate trials, regardless of their performance.
Mean BOLD Activation of the Right Caudate During the Affective Posner Task Over Time
Time frame: up to 6 weeks
This outcome measure determines the extent to which HS+ is characterized by BOLD activation of the right caudate in response to frustrative non-reward (FNR) in the Affective Posner Task during hormone addback relative to baseline in the target population. The Affective Posner Task tests whether HS+ is characterized by reduced subcortical activation in response to frustration. This task is divided into 3 runs: during Run 1 (practice run), participants receive accurate feedback about their performance on the task and do not win or lose money; during Run 2, participants receive accurate feedback about their performance and win or lose 50 cents per trial; and during Run 3 (frustration), participants are told they must respond accurately to win money, but participants are given feedback that they responded too slowly on 60% of accurate trials, regardless of their performance.
Mean BOLD Activation of the Left Caudate During the Affective Posner Task Over Time
Time frame: up to 6 weeks
This outcome measure determines the extent to which HS+ is characterized by BOLD activation of the left caudate in response to frustrative non-reward (FNR) in the Affective Posner Task during hormone addback relative to baseline in the target population. The Affective Posner Task tests whether HS+ is characterized by reduced subcortical activation in response to frustration. This task is divided into 3 runs: during Run 1 (practice run), participants receive accurate feedback about their performance on the task and do not win or lose money; during Run 2, participants receive accurate feedback about their performance and win or lose 50 cents per trial; and during Run 3 (frustration), participants are told they must respond accurately to win money, but participants are given feedback that they responded too slowly on 60% of accurate trials, regardless of their performance.
Mean BOLD Activation of the Right Putamen During the Affective Posner Task Over Time
Time frame: up to 6 weeks
This outcome measure determines the extent to which HS+ is characterized by BOLD activation of the right putamen in response to frustrative non-reward (FNR) in the Affective Posner Task during hormone addback relative to baseline in the target population. The Affective Posner Task tests whether HS+ is characterized by reduced subcortical activation in response to frustration. This task is divided into 3 runs: during Run 1 (practice run), participants receive accurate feedback about their performance on the task and do not win or lose money; during Run 2, participants receive accurate feedback about their performance and win or lose 50 cents per trial; and during Run 3 (frustration), participants are told they must respond accurately to win money, but participants are given feedback that they responded too slowly on 60% of accurate trials, regardless of their performance.
Mean BOLD Activation of the Left Putamen During the Affective Posner Task Over Time
Time frame: up to 6 weeks
This outcome measure determines the extent to which HS+ is characterized by BOLD activation of the left putamen in response to frustrative non-reward (FNR) in the Affective Posner Task during hormone addback relative to baseline in the target population. The Affective Posner Task tests whether HS+ is characterized by reduced subcortical activation in response to frustration. This task is divided into 3 runs: during Run 1 (practice run), participants receive accurate feedback about their performance on the task and do not win or lose money; during Run 2, participants receive accurate feedback about their performance and win or lose 50 cents per trial; and during Run 3 (frustration), participants are told they must respond accurately to win money, but participants are given feedback that they responded too slowly on 60% of accurate trials, regardless of their performance.
Mean BOLD Activation of the Right Nucleus Accumbens During the Affective Posner Task Over Time
Time frame: up to 6 weeks
This outcome measure determines the extent to which HS+ is characterized by BOLD activation of the right nucleus accumbens in response to frustrative non-reward (FNR) in the Affective Posner Task during hormone addback relative to baseline in the target population. The Affective Posner Task tests whether HS+ is characterized by reduced subcortical activation in response to frustration. This task is divided into 3 runs: during Run 1 (practice run), participants receive accurate feedback about their performance on the task and do not win or lose money; during Run 2, participants receive accurate feedback about their performance and win or lose 50 cents per trial; and during Run 3 (frustration), participants are told they must respond accurately to win money, but participants are given feedback that they responded too slowly on 60% of accurate trials, regardless of their performance.
Mean BOLD Activation of the Left Nucleus Accumbens During the Affective Posner Task Over Time
Time frame: up to 6 weeks
This outcome measure determines the extent to which HS+ is characterized by BOLD activation of the left nucleus accumbens in response to frustrative non-reward (FNR) in the Affective Posner Task during hormone addback relative to baseline in the target population. The Affective Posner Task tests whether HS+ is characterized by reduced subcortical activation in response to frustration. This task is divided into 3 runs: during Run 1 (practice run), participants receive accurate feedback about their performance on the task and do not win or lose money; during Run 2, participants receive accurate feedback about their performance and win or lose 50 cents per trial; and during Run 3 (frustration), participants are told they must respond accurately to win money, but participants are given feedback that they responded too slowly on 60% of accurate trials, regardless of their performance.

5 secondary outcomes

Correlation Between the Inventory of Depressive and Anxiety Symptoms (IDAS) Ill -0.8Scale and Threat Attention Bias
Time frame: Endpoint (week 6)
Correlation Between the Inventory of Depressive and Anxiety Symptoms (IDAS) Ill Temper Scale and Right Amygdala-medial Prefrontal Cortex (PFC) BOLD Connectivity.
Time frame: Endpoint (week 6)
Correlation Between the Inventory of Depressive and Anxiety Symptoms (IDAS) Ill Temper Scale and Left Amygdala-medial Prefrontal Cortex (PFC) BOLD Connectivity.
Time frame: Endpoint (week 6)
Correlation Between Irritability and Reactive Aggression During Hormone Addback
Time frame: Endpoint (week 6)
Correlation Between Irritability Subcortical Activation in HS+ During Hormone Addback
Time frame: Endpoint (week 6)

Results and safety

Results posted to the registry on 25 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Hormone Sensitive Women (HS+)	13	13
Hormone Insensitive Women (HS-)	10	10

Primary outcome: Mean Threat Processing Bias During Visual Dot-probe Paradigm Over Time

Time frame: up to 6 weeks. Mean (Standard Deviation). Unit: attention bias in milliseconds

Measure	Hormone Sensitive Women (HS+) n = 10	Hormone Insensitive Women (HS-) n = 9
Baseline (Visit 3)	-0.57 (18.92)	36.92 (110.98)
Hormone Addback (Visit 6)	-9.04 (31.57)	-42.35 (102.99)

Hormone Sensitive Women (HS+) vs Hormone Insensitive Women (HS-): F statistic: 2.164, p = 0.160, repeated measures ANOVA

Population analysed: All available data are reported. Data are missing for participants who had insufficient time to complete the task or due to computer malfunction.

Primary outcome: Mean Right Amygdala-medial Prefrontal Cortex BOLD Connectivity During Implicit Emotion Face Processing Task Over Time

Time frame: up to 6 weeks. Mean (Standard Deviation). Unit: arbitrary units

Measure	Hormone Sensitive Women (HS+) n = 11	Hormone Insensitive Women (HS-) n = 6
Baseline (Visit 3)	0.0174 (0.0606)	0.0533 (0.0338)
Hormone Addback (Visit 6)	-0.0114 (0.0751)	0.00804 (0.0943)

Hormone Sensitive Women (HS+) vs Hormone Insensitive Women (HS-): F statistic: 1.74, p = 0.1922, ANOVA

Population analysed: Participants exceeding the motion threshold and those completing the task incorrectly were excluded.

Primary outcome: Mean Left Amygdala-medial Prefrontal Cortex BOLD Connectivity During Implicit Emotion Face Processing Task Over Time

Time frame: up to 6 weeks. Mean (Standard Deviation). Unit: arbitrary units

Measure	Hormone Sensitive Women (HS+) n = 11	Hormone Insensitive Women (HS-) n = 6
Baseline (Visit 3)	0.0247 (0.0653)	0.0213 (0.0374)
Hormone Addback (Visit 6)	-0.0192 (0.0893)	0.00111 (0.0884)

Hormone Sensitive Women (HS+) vs Hormone Insensitive Women (HS-): F statistic: 0.837, p = 0.368, ANOVA

Population analysed: Participants exceeding the motion threshold and those completing the task incorrectly were excluded.

Primary outcome: Mean Reactive Aggression During Hormone Addback Over Time

Time frame: up to 6 weeks. Mean (Standard Deviation). Unit: Number of subtraction responses

Measure	Hormone Sensitive Women (HS+) n = 13	Hormone Insensitive Women (HS-) n = 10
Baseline (Visit 3)	103.08 (121.68)	129.20 (105.76)
Hormone Addback (Visit 6)	34.62 (44.84)	54.90 (71.85)

Hormone Sensitive Women (HS+) vs Hormone Insensitive Women (HS-): F statistic: 0.23, p = 0.881, ANOVA

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Study visit 3 (intervention start) through visit 7 (Follow-Up), a total of approximately 9 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Hormone Sensitive Women (HS+)	0 of 13 (0%)	12 of 13 (92.3%)	0 of 13
Hormone Insensitive Women (HS-)	0 of 10 (0%)	9 of 10 (90%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27343883Vidal-Ribas P, Brotman MA, Valdivieso I, Leibenluft E, Stringaris A. The Status of Irritability in Psychiatry: A Conceptual and Quantitative Review. J Am Acad Child Adolesc Psychiatry. 2016 Jul;55(7):556-70. doi: 10.1016/j.jaac.2016.04.014. Epub 2016 May 6.
BackgroundAmerican Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders (DSM-5®). (American Psychiatric Pub, 2013).
Background: PubMed 19274052Fava M, Hwang I, Rush AJ, Sampson N, Walters EE, Kessler RC. The importance of irritability as a symptom of major depressive disorder: results from the National Comorbidity Survey Replication. Mol Psychiatry. 2010 Aug;15(8):856-67. doi: 10.1038/mp.2009.20. Epub 2009 Mar 10.
Background: PubMed 15705000Perlis RH, Fraguas R, Fava M, Trivedi MH, Luther JF, Wisniewski SR, Rush AJ. Prevalence and clinical correlates of irritability in major depressive disorder: a preliminary report from the Sequenced Treatment Alternatives to Relieve Depression study. J Clin Psychiatry. 2005 Feb;66(2):159-66; quiz 147, 273-4.
Background: PubMed 16958570Leibenluft E, Cohen P, Gorrindo T, Brook JS, Pine DS. Chronic versus episodic irritability in youth: a community-based, longitudinal study of clinical and diagnostic associations. J Child Adolesc Psychopharmacol. 2006 Aug;16(4):456-66. doi: 10.1089/cap.2006.16.456.
Background: PubMed 26241663Price M, van Stolk-Cooke K. Examination of the interrelations between the factors of PTSD, major depression, and generalized anxiety disorder in a heterogeneous trauma-exposed sample using DSM 5 criteria. J Affect Disord. 2015 Nov 1;186:149-55. doi: 10.1016/j.jad.2015.06.012. Epub 2015 Jul 29.
Background: PubMed 29329048Van Voorhees EE, Dennis PA, Elbogen EB, Fuemmeler B, Neal LC, Calhoun PS, Beckham JC. Characterizing anger-related affect in individuals with posttraumatic stress disorder using ecological momentary assessment. Psychiatry Res. 2018 Mar;261:274-280. doi: 10.1016/j.psychres.2017.12.080. Epub 2018 Jan 3.
Background: PubMed 8827860Penn DL, Spaulding W, Reed D, Sullivan M. The relationship of social cognition to ward behavior in chronic schizophrenia. Schizophr Res. 1996 Jul 5;20(3):327-35. doi: 10.1016/0920-9964(96)00010-2.
Background: PubMed 28192770Bilgi MM, Taspinar S, Aksoy B, Oguz K, Coburn K, Gonul AS. The relationship between childhood trauma, emotion recognition, and irritability in schizophrenia patients. Psychiatry Res. 2017 May;251:90-96. doi: 10.1016/j.psychres.2017.01.091. Epub 2017 Feb 3.
Background: PubMed 26908469McGuire K, Fung LK, Hagopian L, Vasa RA, Mahajan R, Bernal P, Silberman AE, Wolfe A, Coury DL, Hardan AY, Veenstra-VanderWeele J, Whitaker AH. Irritability and Problem Behavior in Autism Spectrum Disorder: A Practice Pathway for Pediatric Primary Care. Pediatrics. 2016 Feb;137 Suppl 2:S136-48. doi: 10.1542/peds.2015-2851L. Epub 2016 Feb 1.
Background: PubMed 12609315Alper KR, Barry JJ, Balabanov AJ. Treatment of psychosis, aggression, and irritability in patients with epilepsy. Epilepsy Behav. 2002 Oct;3(5S):13-18. doi: 10.1016/s1525-5069(02)00500-5.
Background: PubMed 12928511Lopez OL, Becker JT, Sweet RA, Klunk W, Kaufer DI, Saxton J, Habeych M, DeKosky ST. Psychiatric symptoms vary with the severity of dementia in probable Alzheimer's disease. J Neuropsychiatry Clin Neurosci. 2003 Summer;15(3):346-53. doi: 10.1176/jnp.15.3.346.
Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 18 to 24 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Crystal E Schiller, PhD principal investigator

UNC Dept of Psychiatry

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Threat Processing Bias During Visual Dot-probe Paradigm Over Time (time frame: up to 6 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04051320, which also lists 107 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.