Bulimia NervosaPhase 2NCT04278755
Binge Eating & Birth Control
A Phase 2 study testing Drospirenone-Ethinyl Estradiol Oral Tablet in people with Bulimia Nervosa and Binge Eating, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This pilot study examines the effect of stabilizing ovarian hormones on eating behaviors and brain activation in women with binge eating (n=15) using functional magnetic resonance imaging (fMRI) and behavioral tests. This is completed by taking oral contraceptives (birth control) continuously for three months. Read more about this study
- Who is it for?
- Ages 18 to 34 years, women only
- Conditions the study is for
- Bulimia Nervosa, Binge Eating, Eating Disorders
- What is being tested?
- Drospirenone-Ethinyl Estradiol Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2020to 17 May 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 18 to 34 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Participants will include women ages 18-34 with a current Diagnostic and Statistical Manual (DSM-5) diagnosis of a binge eating syndrome and a regular menstrual cycle. Only participants capable of giving informed consent and understanding the risks associated with the study will be enrolled.
- Current binge eating behaviors meeting DSM-5 criteria for a binge eating syndrome
- Age 18-34
- Regular menstrual cycle for at least 3-months
- Free of medication or medical condition that impacts ovarian hormones or is contraindicated for use with study interventions (including birth control)
- Speaks English
Who cannot join
- any foreign metal objects or implants in your body as determined by the safety questionnaires (due to fMRI)
- use of birth control or hormones in the past 3-months
- hormonal contraceptives that are implanted (i.e. progestin intrauterine device or implant)
- current pregnancy, lactation, or < 12-weeks postpartum
- previous serious, negative reaction to birth control
- current smoker
Show all 22Show fewer
- < 18.5 BMI > 31
- history of bipolar disorder or psychotic episodes
- frequent laxative and/or diuretic use
- previous suicide attempt
- abnormal/undiagnosed vaginal bleeding; endometriosis
- recurrent migraine headaches or headaches with focal neurological symptoms
- hypertension or vascular disease (i.e., coronary artery disease, congestive heart failure, cerebrovascular disease)
- diabetes or other circulation problems
- blood clotting disorder
- porphyria
- breast, uterus/cervix, or vaginal cancer
- medical condition or medication use that increases serum potassium levels (including frequent laxative or diuretic use)
- high cholesterol
- history of venous thromboembolus (VTE), deep vein thrombosis, pulmonary embolism, phlebothrombosis, coronary thrombosis, thromboembolism, thrombophlebitis, or any type of blood clot or blood clot disorder (e.g., thromboembolic disease, Factor V Leiden), protein C or S deficiency, heart attack or stroke, atrial fibrillation, heart, liver, kidney, or adrenal disease, endocarditis, liver cancer, malignant melanoma, cholecystitis or pancreatitis, VTE or jaundice caused by pregnancy or birth control pills, recent significant period of immobility (e.g., pregnancy bed rest), immediate family history of a hereditary blood clotting disorder
- Pregnant women will be excluded from participation and women who become pregnant (although unlikely) will be withdrawn. Prior to enrollment, a pregnancy test will be completed. All participants will be required to use non-hormonal forms of birth control (e.g., barrier methods) to avoid pregnancy during this study. If a woman becomes pregnant during the study, participation will be discontinued.
- Any condition or symptoms considered by the study team to detrimentally impact subject safety.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: A Mechanistic Examination of Continuous Cycle Oral Contractive Administration in Binge Eating
This pilot study examines the effect of stabilizing ovarian hormones on eating behaviors and brain activation in women with binge eating (n=15) using functional magnetic resonance imaging (fMRI) and behavioral tests. This is completed by taking oral contraceptives (birth control) continuously for three months. Prior to medication administration and at the end of treatment, eating behaviors will be measured and fMRI will be conducted in order to examine changes in activation in dopamine-reward pathways that occur with oral contraceptive administration. This will assess changes in brain activation that occur with the stabilization of ovarian hormones.
Read the detailed description
Eating disorders (EDs) affect 15 million women in the United States and have one of the highest mortality rates of any mental illness. Despite this, the underlying neurobiology remains poorly understood. EDs predominantly occur in women, and the frequency of certain symptoms change in a predictable pattern over the menstrual cycle; specifically, symptom changes appear to be triggered by normal fluctuations in the ovarian hormones estradiol (E2) and progesterone (P4).
The objective of this study is to examine the impact of ovarian hormone stabilization, through the continuous administration of oral contraceptives (OCs) for 3-months, on brain activation in response to reward and eating behaviors in women who binge eat (n=15) using functional magnetic resonance imaging (fMRI) and behavioral testing. OCs work by suppressing ovulation, thereby reducing E2 and P4 changes that occur pre- and post- ovulation. Because the traditional 21/7 regimen of OC administration (21 active pills followed by 7 days of inactive pills) allows follicles to begin to develop, this leads to the secretion of endogenous E2, and then E2 withdrawal once active pills begin again. This does not result in consistent stabilization. Thus, this study will use OCs in a continuous manner, with no inactive pills.
Participants will complete fMRI imaging and self-report questionnaires prior to OC administration and at the end of OC administration. The investigators will examine within-subject changes that occur in these measures with OC administration. The primary hypothesis is that continuous OC treatment will have a beneficial/stabilizing effect on outcomes of interest. Specifically, symptomatology may decrease from OC use. Results will ultimately provide the pilot data necessary for larger mechanistic trials.
The specific aims are to:
Aim 1: Quantify the effect of ovarian hormone stabilization on eating behaviors in women with binge eating.
Aim 2: Examine the effect of ovarian hormone stabilization on response to reward using fMRI and self-report questionnaires in women with binge eating.
- Conditions
- Bulimia Nervosa, Binge Eating, Eating Disorders, Binge-Eating Disorder
- Being tested
- Drospirenone-Ethinyl Estradiol Oral Tablet
- Medical subject headings
- Bulimia Nervosa, Bulimia, Feeding and Eating Disorders, Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drospirenone-Ethinyl Estradiol Oral TabletDrug
Also called Yasmin
3 Mg-0.03 Mg continuous daily Drospirenone-Ethinyl Estradiol.
| Study group | Role | What they receive |
|---|---|---|
| Continuous OC | Experimental | Continuous daily oral drospirenone + ethinyl estradiol for 84 days (i.e., 12-weeks). Receives: Drug: Drospirenone-Ethinyl Estradiol Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Pre-intervention to Intervention Endpoint in Weekly Average Binge-eating Frequency
Binge eating frequency is based on a weekly diary of self-reported binge eating frequency. Participants were asked how many times during the past week they had a binge eating episode. Scores can range from 0 to infinity as frequency is self-reported as the number of binge eating episodes in the previous week. Higher scores indicate more episodes of binge eating. Change is defined as the average change in self-reported binge eating frequency from pre-intervention to intervention.
Measured: Pre-intervention (week 1) to intervention endpoint (week 12)
Change From Pre-intervention to Intervention Endpoint in Binge Eating Sum Score
Binge eating will be measured using the 8-item binge eating subscale of the Eating Pathology Symptoms Inventory (EPSI), which measures features of binge eating (e.g., consumption of large quantities of food, mindless eating) on a 5-point Likert scale from "never" to "very often." The EPSI scale is designed to assess behavior over the past 28 days. Items are summed for a scale score ranging from 0-32. Higher scores indicate more frequent experiences with binge eating behavior. Change is defined as the average change in the binge eating scale score from pre-intervention to intervention.
Measured: Pre-intervention (week 1) to intervention endpoint (week 12)
Change From Pre-intervention to Intervention Endpoint in Nucleus Accumbens Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT)
Nucleus Accumbens (NAcc) reactivity to reward during the Monetary Incentive Delay (MIDT) task compared pre and post treatment. During MIDT task, participants respond to "win" trials by pressing a button on a button box in the MRI as quickly as possible when they see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more "active" or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared pre- and post-treatment.
Measured: Pre-intervention (week 1) to intervention endpoint (week 12)
Change From Pre-intervention to Intervention Endpoint in Dorsal Striatum Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT)
Dorsal striatum reactivity (defined as caudate signal intensity and putamen signal intensity) to reward during the Monetary Incentive Delay (MIDT) task compared pre and post treatment. During MIDT task, participants respond to "win" trials by pressing a button on a button box in the MRI as quickly as possible when they see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more "active" or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared pre- and post-treatment.
Measured: Pre-intervention (week 1) to intervention endpoint (week 12)
Change From Pre-intervention to Intervention Endpoint in Prefrontal Cortex Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT)
Prefrontal cortex reactivity to reward during the Monetary Incentive Delay (MIDT) task compared pre and post treatment. During MIDT task, participants respond to "win" trials by pressing a button on a button box in the MRI as quickly as possible when they see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more "active" or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared pre- and post-treatment.
Measured: Pre-intervention (week 1) to intervention endpoint (week 12)
Change From Pre-intervention to Intervention Endpoint in Delay Discounting Parameter k
The Monetary Choice Questionnaire will be used to measure delay discounting. Participants will be asked to make a series of hypothetical choices between small, sooner (impulsive) vs. larger, later (self controlled) hypothetical monetary outcomes. k is a hyperbolic function with larger k values indicating more valuation of a larger delayed reward and smaller values indicating preference for more immediate, smaller rewards (more impulsivity). k can range from 0 to .25 with scores of .25 indicating complete valuation of the immediate reward and 0 indicating complete valuation of the larger, delayed reward. Change is defined as the average change in k from pre-intervention to intervention.
Measured: Pre-intervention (week 1) to intervention endpoint (week 12)
Secondary outcomes (2)
Change From Pre-intervention to Intervention Endpoint in Self-reported Reward Sensitivity Subscale Score
Sensitivity to Punishment/Sensitivity to Reward Questionnaire will be used to measure reward sensitivity. The reward sensitivity subscale will be used, which is rated on a true/false scale with scores ranging 0-24. Higher scores indicate more sensitivity to reward. Change is defined as the average change in reward sensitivity from pre-intervention to intervention.
Measured: Pre-intervention (week 1) to intervention endpoint (week 12)
Change From Pre-intervention to Intervention Endpoint in Behavioral Inhibition Subscale Score
The Behavioral Inhibition/Behavioral Activation questionnaire will be used to assess behavioural inhibition (BI). The minimum score on the BI subscale is 7, maximum 28. Greater scores indicate greater BI. Change is defined as the average change in BI from pre-intervention to intervention.
Measured: Pre-intervention (week 1) to intervention endpoint (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start24 Sep 2020
- Primary completion17 May 2022
- Study completion17 May 2022
Why it stopped: Halted prematurely due to COVID-19-related enrollment challenges.
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 (83)Papers the sponsor has linked to this study.
- Other trials for Bulimia NervosaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation of Hope, North Carolina
- Responsible party
- Sponsor
- Investigators
- Jessica Baker, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278755
- Sponsor's protocol ID
- 19-3149
- Status last verified
- Jun 2022
- First submitted
- 18 Feb 2020
- Last updated
- 26 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 University of North Carolina (UNC).
Publications
American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders. Fifth Edition. 2013, Washington, DC: American Psychiatric Press.
Baker JH, Girdler SS, Bulik CM. The role of reproductive hormones in the development and maintenance of eating disorders. Expert Rev Obstet Gynecol. 2012 Nov 1;7(6):573-583. doi: 10.1586/eog.12.54.
PubMed 23585773Edler C, Lipson SF, Keel PK. Ovarian hormones and binge eating in bulimia nervosa. Psychol Med. 2007 Jan;37(1):131-41. doi: 10.1017/S0033291706008956. Epub 2006 Oct 12.
PubMed 17038206Lester NA, Keel PK, Lipson SF. Symptom fluctuation in bulimia nervosa: relation to menstrual-cycle phase and cortisol levels. Psychol Med. 2003 Jan;33(1):51-60. doi: 10.1017/s0033291702006815.
PubMed 12537036Price WA, Torem MS, DiMarzio LR. Premenstrual exacerbation of bulimia. Psychosomatics. 1987 Jul;28(7):378-9. doi: 10.1016/s0033-3182(87)72511-0. No abstract available.
PubMed 3438453Gladis MM, Walsh BT. Premenstrual exacerbation of binge eating in bulimia. Am J Psychiatry. 1987 Dec;144(12):1592-5. doi: 10.1176/ajp.144.12.1592.
PubMed 3688285Asarian L, Geary N. Modulation of appetite by gonadal steroid hormones. Philos Trans R Soc Lond B Biol Sci. 2006 Jul 29;361(1471):1251-63. doi: 10.1098/rstb.2006.1860.
PubMed 16815802Naessen S, Carlstrom K, Bystrom B, Pierre Y, Hirschberg AL. Effects of an antiandrogenic oral contraceptive on appetite and eating behavior in bulimic women. Psychoneuroendocrinology. 2007 Jun;32(5):548-54. doi: 10.1016/j.psyneuen.2007.03.008. Epub 2007 May 2.
PubMed 17475412Monteleone AM, Monteleone P, Esposito F, Prinster A, Volpe U, Cantone E, Pellegrino F, Canna A, Milano W, Aiello M, Di Salle F, Maj M. Altered processing of rewarding and aversive basic taste stimuli in symptomatic women with anorexia nervosa and bulimia nervosa: An fMRI study. J Psychiatr Res. 2017 Jul;90:94-101. doi: 10.1016/j.jpsychires.2017.02.013. Epub 2017 Feb 21.
PubMed 28249187Forbush KT, Wildes JE, Pollack LO, Dunbar D, Luo J, Patterson K, Petruzzi L, Pollpeter M, Miller H, Stone A, Bright A, Watson D. Development and validation of the Eating Pathology Symptoms Inventory (EPSI). Psychol Assess. 2013 Sep;25(3):859-78. doi: 10.1037/a0032639. Epub 2013 Jul 1.
PubMed 23815116Franken IH, Muris P, Georgieva I. Gray's model of personality and addiction. Addict Behav. 2006 Mar;31(3):399-403. doi: 10.1016/j.addbeh.2005.05.022. Epub 2005 Jun 16.
PubMed 15964149Harrison A, O'Brien N, Lopez C, Treasure J. Sensitivity to reward and punishment in eating disorders. Psychiatry Res. 2010 May 15;177(1-2):1-11. doi: 10.1016/j.psychres.2009.06.010. Epub 2010 Apr 9.
PubMed 20381877Knutson B, Westdorp A, Kaiser E, Hommer D. FMRI visualization of brain activity during a monetary incentive delay task. Neuroimage. 2000 Jul;12(1):20-7. doi: 10.1006/nimg.2000.0593.
PubMed 10875899Le Strat Y, Dubertret C, Le Foll B. Prevalence and correlates of major depressive episode in pregnant and postpartum women in the United States. J Affect Disord. 2011 Dec;135(1-3):128-38. doi: 10.1016/j.jad.2011.07.004. Epub 2011 Jul 29.
PubMed 21802737Lee EE, Nieman LK, Martinez PE, Harsh VL, Rubinow DR, Schmidt PJ. ACTH and cortisol response to Dex/CRH testing in women with and without premenstrual dysphoria during GnRH agonist-induced hypogonadism and ovarian steroid replacement. J Clin Endocrinol Metab. 2012 Jun;97(6):1887-96. doi: 10.1210/jc.2011-3451. Epub 2012 Mar 30.
PubMed 22466349
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mechanistic Examination of Continuous Cycle Oral Contractive Administration in Binge Eating
- ClinicalTrials.gov ID
- NCT04278755
- Acronym / sponsor ID
- 19-3149
- Conditions
- Bulimia Nervosa, Binge Eating, Eating Disorders, Binge-Eating Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Halted prematurely due to COVID-19-related enrollment challenges.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Foundation of Hope, North Carolina
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- 17 May 2022 (actual)
- Study completion
- 17 May 2022 (actual)
- First posted
- 20 Feb 2020 (actual)
- Results
- Posted 26 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study examines the effect of stabilizing ovarian hormones on eating behaviors and brain activation in women with binge eating (n=15) using functional magnetic resonance imaging (fMRI) and behavioral tests. This is completed by taking oral contraceptives (birth control) continuously for three months. Prior to medication administration and at the end of treatment, eating behaviors will be measured and fMRI will be conducted in order to examine changes in activation in dopamine-reward pathways that occur with oral contraceptive administration. This will assess changes in brain activation that occur with the stabilization of ovarian hormones.
Detailed description
Eating disorders (EDs) affect 15 million women in the United States and have one of the highest mortality rates of any mental illness. Despite this, the underlying neurobiology remains poorly understood. EDs predominantly occur in women, and the frequency of certain symptoms change in a predictable pattern over the menstrual cycle; specifically, symptom changes appear to be triggered by normal fluctuations in the ovarian hormones estradiol (E2) and progesterone (P4).
The objective of this study is to examine the impact of ovarian hormone stabilization, through the continuous administration of oral contraceptives (OCs) for 3-months, on brain activation in response to reward and eating behaviors in women who binge eat (n=15) using functional magnetic resonance imaging (fMRI) and behavioral testing. OCs work by suppressing ovulation, thereby reducing E2 and P4 changes that occur pre- and post- ovulation. Because the traditional 21/7 regimen of OC administration (21 active pills followed by 7 days of inactive pills) allows follicles to begin to develop, this leads to the secretion of endogenous E2, and then E2 withdrawal once active pills begin again. This does not result in consistent stabilization. Thus, this study will use OCs in a continuous manner, with no inactive pills.
Participants will complete fMRI imaging and self-report questionnaires prior to OC administration and at the end of OC administration. The investigators will examine within-subject changes that occur in these measures with OC administration. The primary hypothesis is that continuous OC treatment will have a beneficial/stabilizing effect on outcomes of interest. Specifically, symptomatology may decrease from OC use. Results will ultimately provide the pilot data necessary for larger mechanistic trials.
The specific aims are to:
Aim 1: Quantify the effect of ovarian hormone stabilization on eating behaviors in women with binge eating.
Aim 2: Examine the effect of ovarian hormone stabilization on response to reward using fMRI and self-report questionnaires in women with binge eating.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Continuous OC | Experimental | Drug: Drospirenone-Ethinyl Estradiol Oral TabletContinuous daily oral drospirenone + ethinyl estradiol for 84 days (i.e., 12-weeks). |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants will include women ages 18-34 with a current Diagnostic and Statistical Manual (DSM-5) diagnosis of a binge eating syndrome and a regular menstrual cycle. Only participants capable of giving informed consent and understanding the risks associated with the study will be enrolled.
- Current binge eating behaviors meeting DSM-5 criteria for a binge eating syndrome
- Age 18-34
- Regular menstrual cycle for at least 3-months
- Free of medication or medical condition that impacts ovarian hormones or is contraindicated for use with study interventions (including birth control)
Key exclusion criteria (22 listed)
- any foreign metal objects or implants in your body as determined by the safety questionnaires (due to fMRI)
- use of birth control or hormones in the past 3-months
- hormonal contraceptives that are implanted (i.e. progestin intrauterine device or implant)
- current pregnancy, lactation, or < 12-weeks postpartum
- previous serious, negative reaction to birth control
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 |
|---|---|---|
| Drospirenone-Ethinyl Estradiol Oral TabletAlso: Yasmin3 Mg-0.03 Mg continuous daily Drospirenone-Ethinyl Estradiol. | Drug | Continuous OC |
Primary outcome
Change From Pre-intervention to Intervention Endpoint in Weekly Average Binge-eating Frequency
Time frame: Pre-intervention (week 1) to intervention endpoint (week 12)
Binge eating frequency is based on a weekly diary of self-reported binge eating frequency. Participants were asked how many times during the past week they had a binge eating episode. Scores can range from 0 to infinity as frequency is self-reported as the number of binge eating episodes in the previous week. Higher scores indicate more episodes of binge eating. Change is defined as the average change in self-reported binge eating frequency from pre-intervention to intervention.
Change From Pre-intervention to Intervention Endpoint in Binge Eating Sum Score
Time frame: Pre-intervention (week 1) to intervention endpoint (week 12)
Binge eating will be measured using the 8-item binge eating subscale of the Eating Pathology Symptoms Inventory (EPSI), which measures features of binge eating (e.g., consumption of large quantities of food, mindless eating) on a 5-point Likert scale from "never" to "very often." The EPSI scale is designed to assess behavior over the past 28 days. Items are summed for a scale score ranging from 0-32. Higher scores indicate more frequent experiences with binge eating behavior. Change is defined as the average change in the binge eating scale score from pre-intervention to intervention.
Change From Pre-intervention to Intervention Endpoint in Nucleus Accumbens Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT)
Time frame: Pre-intervention (week 1) to intervention endpoint (week 12)
Nucleus Accumbens (NAcc) reactivity to reward during the Monetary Incentive Delay (MIDT) task compared pre and post treatment. During MIDT task, participants respond to "win" trials by pressing a button on a button box in the MRI as quickly as possible when they see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more "active" or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared pre- and post-treatment.
Change From Pre-intervention to Intervention Endpoint in Dorsal Striatum Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT)
Time frame: Pre-intervention (week 1) to intervention endpoint (week 12)
Dorsal striatum reactivity (defined as caudate signal intensity and putamen signal intensity) to reward during the Monetary Incentive Delay (MIDT) task compared pre and post treatment. During MIDT task, participants respond to "win" trials by pressing a button on a button box in the MRI as quickly as possible when they see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more "active" or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared pre- and post-treatment.
Change From Pre-intervention to Intervention Endpoint in Prefrontal Cortex Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT)
Time frame: Pre-intervention (week 1) to intervention endpoint (week 12)
Prefrontal cortex reactivity to reward during the Monetary Incentive Delay (MIDT) task compared pre and post treatment. During MIDT task, participants respond to "win" trials by pressing a button on a button box in the MRI as quickly as possible when they see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more "active" or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared pre- and post-treatment.
Change From Pre-intervention to Intervention Endpoint in Delay Discounting Parameter k
Time frame: Pre-intervention (week 1) to intervention endpoint (week 12)
The Monetary Choice Questionnaire will be used to measure delay discounting. Participants will be asked to make a series of hypothetical choices between small, sooner (impulsive) vs. larger, later (self controlled) hypothetical monetary outcomes. k is a hyperbolic function with larger k values indicating more valuation of a larger delayed reward and smaller values indicating preference for more immediate, smaller rewards (more impulsivity). k can range from 0 to .25 with scores of .25 indicating complete valuation of the immediate reward and 0 indicating complete valuation of the larger, delayed reward. Change is defined as the average change in k from pre-intervention to intervention.
2 secondary outcomes
Change From Pre-intervention to Intervention Endpoint in Self-reported Reward Sensitivity Subscale Score
Time frame: Pre-intervention (week 1) to intervention endpoint (week 12)
Change From Pre-intervention to Intervention Endpoint in Behavioral Inhibition Subscale Score
Time frame: Pre-intervention (week 1) to intervention endpoint (week 12)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundAmerican Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders. Fifth Edition. 2013, Washington, DC: American Psychiatric Press.
- Background: PubMed 23585773Baker JH, Girdler SS, Bulik CM. The role of reproductive hormones in the development and maintenance of eating disorders. Expert Rev Obstet Gynecol. 2012 Nov 1;7(6):573-583. doi: 10.1586/eog.12.54.
- Background: PubMed 17038206Edler C, Lipson SF, Keel PK. Ovarian hormones and binge eating in bulimia nervosa. Psychol Med. 2007 Jan;37(1):131-41. doi: 10.1017/S0033291706008956. Epub 2006 Oct 12.
- Background: PubMed 12537036Lester NA, Keel PK, Lipson SF. Symptom fluctuation in bulimia nervosa: relation to menstrual-cycle phase and cortisol levels. Psychol Med. 2003 Jan;33(1):51-60. doi: 10.1017/s0033291702006815.
- Background: PubMed 3438453Price WA, Torem MS, DiMarzio LR. Premenstrual exacerbation of bulimia. Psychosomatics. 1987 Jul;28(7):378-9. doi: 10.1016/s0033-3182(87)72511-0. No abstract available.
- Background: PubMed 3688285Gladis MM, Walsh BT. Premenstrual exacerbation of binge eating in bulimia. Am J Psychiatry. 1987 Dec;144(12):1592-5. doi: 10.1176/ajp.144.12.1592.
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- 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 University of North Carolina (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.
Jessica Baker, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Drospirenone-Ethinyl Estradiol Oral Tablet in people with Bulimia Nervosa and Binge Eating, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 6 inclusion and 22 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: stopped early, as of the sponsor's last update on 26 Jul 2022. 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 26 Jul 2022). 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?
Change From Pre-intervention to Intervention Endpoint in Weekly Average Binge-eating Frequency (time frame: Pre-intervention (week 1) to intervention endpoint (week 12)). The study lists 6 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 NCT04278755, which also lists 83 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 26 Jul 2022; AzTrials last refreshed its copy on 28 Oct 2026.