N-acetylcysteine in the Treatment of Depressive Symptoms in Youth at High-risk for Bipolar Disorder: a Functional Connectivity Study
试验速览
- 阶段
- 不适用
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Hamilton Depression Rating Scale (HAM-D) scores
研究概览
简要总结
N-acetylcysteine in the treatment of depressive symptoms in youth at high-risk for bipolar disorder: a functional connectivity study
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
N-acetyl cysteine
Following the screening and review of all laboratory studies, patients will be scheduled to receive N-acetylcysteine.
干预措施: N-acetyl cysteine (Drug)
结局指标
主要结局
Hamilton Depression Rating Scale (HAM-D) scores
时间窗: Baseline to endpoint (8 weeks)
The primary outcome will be change in depressive symptoms, as measured by HAMD scores, from baseline to endpoint.
次要结局
- Young Mania Rating Scale (YMRS) scores(Baseline to endpoint (8 weeks))
- Hamilton Anxiety Rating Scale (HAM-A) scores to measure anxiety symptoms(Baseline to endpoint (8 weeks))
- Clinical Global Impression of Severity (CGI-S) scores(Baseline to endpoint (8 weeks))
- Correlation between change in depressive symptoms and change in connectivity index(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(Baseline to endpoint (8 weeks))
研究者
Fabiano Nery
Assistant Professor of Psychiatry in the Department of Psychiatry and Behavioral Neuroscience
University of Cincinnati