NCT00272025终止1 期
Six Week Double Blind, Randomized Trial of Escitalopram Add On for Treatment Resistant Bipolar Depression
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- To evaluate the response rates when Escitalopram vs. placeboes added to the current mood stabilizer or antipsychotic medication
研究概览
简要总结
To determine if adding Escitalopram to current mood stabilizer (MS) or atypical antipsychotic (AA) will improve in rates similar to or better than adding a placebo (inactive pill)in resistant bipolar patients.
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 (Participant, 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
- 是
入选标准
- •Age 18 or older
- •Diagnosis of Bipolar Disorder and currently be in depressive state, and not responded to mood stabilizer or atypical antipsychotic alone or combined with an antidepressant medication.
排除标准
- •Pregnant or breastfeeding
- •History of seizure disorder or other unstable medical condition
- •Received Electroconvulsive Therapy or Transcranial Magnetic Stimulation in the last three months
- •Experienced hallucinations or delusions
研究组 & 干预措施
1
Active Comparator
There is a 50% chance of being randomized to Escitalopram in addition to current atypical antipsychotic (minimum dose risperidone 3mg, olanzapine 10mg or seroquel 400mg) or mood stabilizer (lithium, epival or lamotrigine)
干预措施: Escitalopram (Drug)
2
Placebo Comparator
to be filled in
干预措施: placebo (Drug)
结局指标
主要结局
To evaluate the response rates when Escitalopram vs. placeboes added to the current mood stabilizer or antipsychotic medication
时间窗: 6 weeks
次要结局
- To evaluate efficacy, safety and tolerability of added Escitalopram, to a mood stabilizer or atypical antipsychotic.(6 weeks)
研究者
Dr. Roumen Milev
Principal Investigator
Queen's University
研究点 (1)
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