DepressionNCT02865629
N-acetylcysteine in the Treatment of Depressive Symptoms in Bipolar Offspring
A study testing N-acetyl cysteine in people with Depression, run by University of Cincinnati at 1 site in United States.
Trial summary
N-acetylcysteine in the treatment of depressive symptoms in youth at high-risk for bipolar disorder: a functional connectivity study Read more about this study
- Who is it for?
- Ages 15 to 24 years
- Conditions the study is for
- Depression
- What is being tested?
- N-acetyl cysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 15 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female subjects 15 years, 0 months - 24 years, 11 months of age at screening
- For minor, at least one parent or step-parent/guardian with whom the subject lives is willing to participate in research sessions
- For minor, the child and relative(s) are able and willing to give written informed assent/consent to participate, respectively
- Subject has at least one first degree relative with Bipolar I Disorder, as assessed by the Structured Clinical Interview for DSM (SCID) or the Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS-PL)
- Subject shows evidence of current significant depressive symptoms as determined by a current Hamilton Depression Rating Scale (HAM-D) greater or equal to 8
Who cannot join
- Patient has presence of current or lifetime history of manic or hypomanic mood episodes, psychotic disorders including schizophrenia, current major depressive episode, and/or more than two prior major depressive episodes
- Patient has a DSM-5 diagnosis of autism, pervasive developmental disorder, OCD, PTSD, or Tourette's disorder
- Patient has drug or alcohol abuse or dependence disorders in the three months prior to study recruitment, although a lifetime history of substance or alcohol disorders can be present if the patient has been abstinent for at least three months
- Pregnancy; participants will be encouraged but not mandated to discuss a positive pregnancy test with their guardians (if minors) and we will follow local laws
- Patient has history of major neurological disorders (such as epilepsy), or head trauma with > 10 minutes loss of consciousness
- Patient has evidence of mental retardation (IQ less than 70), as determined by the Wechsler Abbreviated Scale of Intelligence (WASI)
- Patient has any contraindication for MRI, including metal in the body related to an injury or surgery (e.g., surgical clips, metal fragments in the eyes), piercings that cannot be removed, or braces
- Patient has history of allergic reaction to N-acetylcysteine
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Cincinnati, Department of Psychiatry & Behavioral Neuroscience
Cincinnati, Ohio, 45219
Stephanie Schaeper, B.S., 513-558-5953, schaepsi@ucmail.uc.edu
Fabiano Nery, MD
About this study
Official title: N-acetylcysteine in the Treatment of Depressive Symptoms in Youth at High-risk for Bipolar Disorder: a Functional Connectivity Study
N-acetylcysteine in the treatment of depressive symptoms in youth at high-risk for bipolar disorder: a functional connectivity study
Read the detailed description
To conduct an 8-week, open label study of N-acetylcysteine for the treatment of depressive symptoms in youth at high risk for bipolar disorder, with resting state functional magnetic resonance imaging (fMRI) examinations at baseline and endpoint. This proposal is innovative because it investigates the efficacy and tolerability of a novel pharmacological treatment in youth offspring of bipolar disorder, and examines the neurophysiology of predictors of mood disorders in youth at high risk for bipolar disorder. This study will obtain pilot data to propose a larger, neuroimaging-based, double-blind, placebo-controlled trial of N-acetylcysteine in youth at high risk for bipolar disorder. The expected outcome, that N-acetylcysteine will be efficacious in ameliorating depressive symptoms in youth at high risk for bipolar disorder, and that it will demonstrate improvement in functional connectivity within the left frontostriatal circuit associated with treatment response.
- Conditions
- Depression
- Being tested
- N-acetyl cysteine
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetyl cysteineDrug
Also called Acetylcysteine
N-acetylcysteine will be initiated at 600 mg PO daily for Week 1, then increased to 600 mg PO twice a day for Week 2, then increased to 600 mg PO morning and 1200 mg PO evening for Week 3, and then increased to 1200 mg PO twice a day for Week 4-8. Doses might be decreased anytime if clinically indicated. Following the study, all patients will be referred to treatment as usual. Adherence will be assessed in weekly visits in the first month and then bi-weekly in the second month. Adherence will be assessed by subject interview, pill counts during each study visit, and by legal guardian interview (if minor).
| Study group | Role | What they receive |
|---|---|---|
| N-acetyl cysteine | Experimental | Following the screening and review of all laboratory studies, patients will be scheduled to receive N-acetylcysteine. Receives: Drug: N-acetyl cysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale (HAM-D) scores
The primary outcome will be change in depressive symptoms, as measured by HAMD scores, from baseline to endpoint.
Measured: Baseline to endpoint (8 weeks)
Secondary outcomes (5)
Young Mania Rating Scale (YMRS) scores
A secondary outcome will be change in manic symptom, measured by YMRS scores, from baseline to endpoint.
Measured: Baseline to endpoint (8 weeks)
Hamilton Anxiety Rating Scale (HAM-A) scores to measure anxiety symptoms
A secondary outcome will be change anxiety symptoms, as measured by HAM-A scores, from baseline to endpoint.
Measured: Baseline to endpoint (8 weeks)
Clinical Global Impression of Severity (CGI-S) scores
A secondary outcome will be change in subjects' overall clinical condition, as measured by CGI-S scores, from baseline to endpoint.
Measured: Baseline to endpoint (8 weeks)
Connectivity index, as defined by the temporal bivariate correlation between fMRI signal fluctuations in the left ventrolateral prefrontal cortex and the left striatum
A secondary outcome will be change in functional connectivity, as measured by the connectivity index, between the left ventrolateral prefrontal cortex and the left striatum from baseline to endpoint. The connectivity index is defined as the temporal bivariate correlation between fMRI signal fluctuations in the 2 regions of interest.
Measured: Baseline to endpoint (8 weeks)
Correlation between change in depressive symptoms and change in connectivity index
A secondary outcome will be correlation between changes in depressive symptoms and changes in functional connectivity, as measured by the connectivity index, between the left ventrolateral prefrontal cortex and left striatum from baseline to endpoint. The connectivity index is defined as the temporal bivariate correlations between fMRI signal fluctuations in the 2 regions of interest.
Measured: Baseline to endpoint (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabiano Nery, University of Cincinnati
- Investigators
- Fabiano G. Nery, MD, PhD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865629
- Sponsor's protocol ID
- Nery UCNI NAC study
- Status last verified
- May 2018
- First submitted
- 28 Jun 2016
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- N-acetylcysteine in the Treatment of Depressive Symptoms in Youth at High-risk for Bipolar Disorder: a Functional Connectivity Study
- ClinicalTrials.gov ID
- NCT02865629
- Acronym / sponsor ID
- Nery UCNI NAC study
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 12 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
N-acetylcysteine in the treatment of depressive symptoms in youth at high-risk for bipolar disorder: a functional connectivity study
Detailed description
To conduct an 8-week, open label study of N-acetylcysteine for the treatment of depressive symptoms in youth at high risk for bipolar disorder, with resting state functional magnetic resonance imaging (fMRI) examinations at baseline and endpoint. This proposal is innovative because it investigates the efficacy and tolerability of a novel pharmacological treatment in youth offspring of bipolar disorder, and examines the neurophysiology of predictors of mood disorders in youth at high risk for bipolar disorder. This study will obtain pilot data to propose a larger, neuroimaging-based, double-blind, placebo-controlled trial of N-acetylcysteine in youth at high risk for bipolar disorder. The expected outcome, that N-acetylcysteine will be efficacious in ameliorating depressive symptoms in youth at high risk for bipolar disorder, and that it will demonstrate improvement in functional connectivity within the left frontostriatal circuit associated with treatment response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| N-acetyl cysteine | Experimental | Drug: N-acetyl cysteineFollowing the screening and review of all laboratory studies, patients will be scheduled to receive N-acetylcysteine. |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Male or female subjects 15 years, 0 months - 24 years, 11 months of age at screening
- For minor, at least one parent or step-parent/guardian with whom the subject lives is willing to participate in research sessions
- For minor, the child and relative(s) are able and willing to give written informed assent/consent to participate, respectively
- Subject has at least one first degree relative with Bipolar I Disorder, as assessed by the Structured Clinical Interview for DSM (SCID) or the Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS-PL)
- Subject shows evidence of current significant depressive symptoms as determined by a current Hamilton Depression Rating Scale (HAM-D) greater or equal to 8
Key exclusion criteria (8 listed)
- Patient has presence of current or lifetime history of manic or hypomanic mood episodes, psychotic disorders including schizophrenia, current major depressive episode, and/or more than two prior major depressive episodes
- Patient has a DSM-5 diagnosis of autism, pervasive developmental disorder, OCD, PTSD, or Tourette's disorder
- Patient has drug or alcohol abuse or dependence disorders in the three months prior to study recruitment, although a lifetime history of substance or alcohol disorders can be present if the patient has been abstinent for at least three months
- Pregnancy; participants will be encouraged but not mandated to discuss a positive pregnancy test with their guardians (if minors) and we will follow local laws
- Patient has history of major neurological disorders (such as epilepsy), or head trauma with > 10 minutes loss of consciousness
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 |
|---|---|---|
| N-acetyl cysteineAlso: AcetylcysteineN-acetylcysteine will be initiated at 600 mg PO daily for Week 1, then increased to 600 mg PO twice a day for Week 2, then increased to 600 mg PO morning and 1200 mg PO evening for Week 3, and then increased to 1200 mg PO twice a day for Week 4-8. Doses might be decreased anytime if clinically indicated. Following the study, all patients will be referred to treatment as usual. Adherence will be assessed in weekly visits in the first month and then bi-weekly in the second month. Adherence will be assessed by subject interview, pill counts during each study visit, and by legal guardian interview (if minor). | Drug | N-acetyl cysteine |
Primary outcome
Hamilton Depression Rating Scale (HAM-D) scores
Time frame: Baseline to endpoint (8 weeks)
The primary outcome will be change in depressive symptoms, as measured by HAMD scores, from baseline to endpoint.
5 secondary outcomes
Young Mania Rating Scale (YMRS) scores
Time frame: Baseline to endpoint (8 weeks)
Hamilton Anxiety Rating Scale (HAM-A) scores to measure anxiety symptoms
Time frame: Baseline to endpoint (8 weeks)
Clinical Global Impression of Severity (CGI-S) scores
Time frame: Baseline to endpoint (8 weeks)
Connectivity index, as defined by the temporal bivariate correlation between fMRI signal fluctuations in the left ventrolateral prefrontal cortex and the left striatum
Time frame: Baseline to endpoint (8 weeks)
Correlation between change in depressive symptoms and change in connectivity index
Time frame: Baseline to endpoint (8 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
- Individual participant dataSharing planned: No
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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.
Fabiano G. Nery, MD, PhD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N-acetyl cysteine in people with Depression, run by University of Cincinnati 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 14 May 2018. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabiano G. Nery, MD, PhD (513.558.5035, neryfo@email.uc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale (HAM-D) scores (time frame: Baseline to endpoint (8 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2018.