NCT00812058已完成2 期
A Phase II Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Study to Assess the Safety, Tolerability and Efficacy of RG2417 (Uridine) in the Treatment of Bipolar I Depression
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 36
- 主要终点
- MADRS Score
研究概览
简要总结
The purpose of this study is to test a new drug, RG2417, to see how the drug affects symptoms of bipolar I depression and to make sure it is safe in humans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Bipolar I Disorder, most recent episode depressed
- •History of 2 or more manic or mixed episodes, at least one of which required pharmacologic treatment for manic symptoms
排除标准
- •Current manic, hypomanic or mixed episode
- •Rapid cycling bipolar disorder (4 or more mood episodes in the last year)
- •Dementia or any other Axis I diagnosis (besides bipolar I) that requires treatment
- •Alcohol or drug dependence within 6 months; alcohol or drug abuse within 3 months
- •Positive urine drug test for amphetamines, cocaine metabolites, opiates and/or phencyclidine(PCP)
- •Axis II diagnosis likely to interfere with study compliance
- •Serious suicidal or homicidal risk
- •Sensitivity to any of the drug ingredients, including lactose
- •Women who are pregnant, breast feeding or refuse to use adequate birth control
- •Current seizure disorder
- •Current episode of depression is longer than 1 year
研究组 & 干预措施
RG2417
Experimental
Oral RG2417 taken twice daily for 8 weeks
干预措施: RG2417 (Drug)
Placebo
Placebo Comparator
Oral placebo taken twice daily for 8 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
MADRS Score
时间窗: Baseline and weekly for 8 weeks
次要结局
- Safety Findings (includes AE frequency, YMRS Score and CSSR-S Score)(Baseline, 8 weeks of study drug dosing and one follow up visit at 4 weeks)
- CGI-BP-S(Baseline and weekly for 8 weeks)
研究者
研究点 (36)
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