A Placebo Controlled Trial of the Dopamine D-2 Receptor Agonist Ropinirole in Treatment of 60 Patients With Refractory Bipolar I and II Depression.
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Hamilton Depression Rating Scale Score
研究概览
简要总结
We hypothesize that depressed patients who have not responded to their current antidepressant medication will respond to the addition of ropinirole to their current regimen at a rate better than placebo.
详细描述
Most pharmacologic treatments of depression rely on serotonergic and/or noradrenergic mechanisms. Yet, evidence both from animal studies and from human trials suggests a role for dopaminergic pathways and particularly for dopamine D2-like receptors in the treatment of depression. In recent years, two new selective agonists of dopamine D2-like receptors have come into clinical use for the treatment of parkinsonism. Preliminary evidence suggests that these drugs might be useful as antidepressants. We are testing whether one of these agonists, ropinirole, is an effective augmentation strategy in depressed patients in a double-blind, randomized, controlled trial. We are recruiting unipolar and bipolar patients who remained depressed (modified Hamilton Depression Rating Scale score greater than 16) despite at least 4 weeks of treatment with an adequate dose of antidepressant medication. Patients receive either 2mg of oral ropinirole or placebo twice daily added on to their current medication and are evaluated weekly over 7 weeks and are assessed weekly using two depression rating scales.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-IV Major Depression OR Bipolar I or II Disorder - Currently Depressed
- •One month of a stable, adequate dose of antidepressant medication
- •Bipolar patients must have a mood stabilizer
- •At least 18 years old
- •Modified HDRS-21 more than 16 (Scores reverse vegetative symptoms.)
- •Informed Consent
排除标准
- •Antipsychotic Medication
- •Drug or Alcohol Abuse
- •Active Suicidality
- •Rapid Cycling Bipolar Disorder
- •Neurologic or Dementing Illness
- •Psychosis
- •Parkinsonism
- •Pregnancy
结局指标
主要结局
Hamilton Depression Rating Scale Score
次要结局
- Montgomery Asberg Depression Rating Scale Score
