NCT00322764已完成2 期
Dose-Escalating, Phase II Study to Assess the Safety and Tolerability of RG2417 in the Treatment of Bipolar I Depression
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 22
- 主要终点
- Improvement of MADRS and CGI BP C for RG2417 treatment in comparison to placebo
研究概览
简要总结
The primary purpose of this study is to determine the safety and efficacy of oral RG2417 (Uridine) when administered to patients with Bipolar I depression twice daily for six weeks.
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
- Double
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
- •DSM-IV-TR diagnosis of Bipolar I Depression
- •18 to 65 years of age, inclusive
- •Depressive phase, as measured by MADRS greater than or equal to 20 at Screening and Day1
- •Duration of current depressive episode of at least four weeks by Day 1
- •Competent to give informed consent
排除标准
- •Manic/hypomanic/mixed episode as determined by the MINI at Screening and/or a Young Mania Rating Scale (YMRS) score of > 12 at Screening and/or Day 1
- •Dementia or any current Axis I diagnosis (excluding bipolar I) requiring pharmacological treatments
- •A history of alcohol or substance dependence within six months of Day 1, or a history of alcohol or substance abuse within three months of Day 1
- •Urine drug screen positive for amphetamines, cocaine metabolites, opiates and/or phencyclindine (PCP)
- •An Axis II diagnosis that is likely to interfere with protocol compliance
- •Initiation of or increase in psychotherapy within 4 weeks of Screening
- •Psychotropic medication (excluding fluoxetine) within 24 hours of initiation of study drug on Day 1; fluoxetine within 2 weeks of initiation of study drug on Day 1
- •Serious suicidal or homicidal risk as determined by the investigator and/or a score of > 5 on the suicide item #10 of the MADRS at Screening and/or Day 1
- •History of sensitivity to any of the ingredients in the study drug
- •Clinically significant abnormality in any screening laboratory results
- •Clinically significant organic disease, including cardiovascular, endocrine, hepatic, pulmonary, neurologic, or renal disease, or any other medical condition, serious intercurrent illness, or extenuating circumstances that, in the opinion of the investigator, would interfere with the performance or interpretability of, or put the patient at risk from, the study procedures
- •Women who are pregnant, breastfeeding, or refuse to use adequate birth control
- •Current seizure disorder
- •Participation in an investigational drug study within twenty-eight days of Day 1
- •Current psychotic episode
- •Clozaril use and/or electroconvulsive therapy within six months of Day 1
- •Failure of three or more adequate trials of standard therapies for depression during the current episode
- •Current episode of depression is longer than one year
结局指标
主要结局
Improvement of MADRS and CGI BP C for RG2417 treatment in comparison to placebo
次要结局
未报告次要终点
研究者
研究点 (22)
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