N-acetylcysteine in the Treatment of Depressive Symptoms in Bipolar Offspring
- Registration Number
- NCT02865629
- Lead Sponsor
- University of Cincinnati
- Brief Summary
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 22
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description N-acetyl cysteine N-acetyl cysteine Following the screening and review of all laboratory studies, patients will be scheduled to receive N-acetylcysteine.
- Primary Outcome Measures
Name Time Method Hamilton Depression Rating Scale (HAM-D) scores Baseline to endpoint (8 weeks) The primary outcome will be change in depressive symptoms, as measured by HAMD scores, from baseline to endpoint.
- Secondary Outcome Measures
Name Time Method Young Mania Rating Scale (YMRS) scores Baseline to endpoint (8 weeks) A secondary outcome will be change in manic symptom, measured by YMRS scores, from baseline to endpoint.
Clinical Global Impression of Severity (CGI-S) scores Baseline to endpoint (8 weeks) A secondary outcome will be change in subjects' overall clinical condition, as measured by CGI-S scores, from baseline to endpoint.
Hamilton Anxiety Rating Scale (HAM-A) scores to measure anxiety symptoms Baseline to endpoint (8 weeks) A secondary outcome will be change anxiety symptoms, as measured by HAM-A scores, from baseline to endpoint.
Correlation between change in depressive symptoms and change in connectivity index Baseline to endpoint (8 weeks) 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.
Connectivity index, as defined by the temporal bivariate correlation between fMRI signal fluctuations in the left ventrolateral prefrontal cortex and the left striatum Baseline to endpoint (8 weeks) 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.
Trial Locations
- Locations (1)
University of Cincinnati, Department of Psychiatry & Behavioral Neuroscience
🇺🇸Cincinnati, Ohio, United States