Riluzole in the Treatment of Bipolar Depression: A Study of the Association Between Clinical Response and Change in Brain Glutamate Levels as Measured by Proton Magnetic Resonance Spectroscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change in Hamilton Depression Rating Scale
研究概览
简要总结
Bipolar disorder is a common and often chronic and debilitating mental illness. The depressive phase of bipolar disorder contributes the largest portion of the disorder, and treatment resistant bipolar depression represents a significant public health problem. Recent research has suggested that bipolar depression is associated with elevated brain glutamate activity. We hypothesize that riluzole, a drug approved for ALS which inhibits glutamate activity, will lead to clinical improvement in patients with bipolar depression.
详细描述
We hypothesize that riluzole will lead to significant reduction in depressive symptoms as measured by the Hamilton Depression Rating Scale (HAM-D). Additionally, improvement in depressive symptoms will be associated with reduced glutamate levels in the anterior cingulate cortex, but not parieto-occipital cortex, both at day two and day 42.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female age 18-65
- •Meets DSM-IV criteria for Bipolar Disorder and is currently depressed
- •Current score of >/= 18 on the Hamilton Depression Scale
排除标准
- •Active psychotic/manic symptoms
- •Lifetime history of schizophrenia or obsessive compulsive disorder
- •Clinically significant medical disease
- •Women who are pregnant or lactating and women who are not using a medically accepted method of contraception.
研究组 & 干预措施
Riluzole
Riluzole 50 mg twice daily for 2 weeks, increased to riluzole 50 mg in the morning and 100 mg in the evening for 1 week if tolerated, with a further increase to riluzole 100 mg twice daily if tolerated for 3 weeks.
干预措施: Riluzole (Drug)
结局指标
主要结局
Change in Hamilton Depression Rating Scale
时间窗: Baseline (week 0) - week 6
The Hamilton Depression rating Scale is a clinician-rated scale that measures the severity of depression symptoms using 21 items. Minimum score is zero and maximum score is 65. Higher scores indicate more severe depressive symptoms.
次要结局
- Clinical Global Impression Scale(Baseline (week 0) - week 6)
- Montgomery Asberg Depression Rating Scale(Baseline (week 0) - week 6)
- Young Mania Rating Scale(Baseline (week 0) - week 6)
研究者
Brian P. Brennan, MD
Associate Director of Translational Neuroscience Research
Mclean Hospital