NCT00568672撤回3 期
Optimal Duration of Olanzapine Add-on Therapy in Major Depression: a Placebo-controlled, Randomized, Phase III, Pilot Study in Parallel Group Design
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Relapse Rate, Hamilton Depression Rating Scale (17 item version)
研究概览
简要总结
Evaluation of olanzapine versus placebo in the continuation therapy of subjects with major depression who had a response with additional olanzapine to an antidepressant.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •informed consent
- •age 18 - 80
- •diagnosis of major depression according dsm-iv, unipolar course
- •Hamilton-Depression-Rating-Scale (17 item score) > 18 prior to inclusion
- •response towards therapy with antidepressant and olanzapine as defined > 50 % reduction of HAMDD score
- •negative pregancy test
- •highly effective contraceptive method in women
- •no participation in other trial according to German Drug Laq
- •normal liver function
排除标准
- •pregnancy, lactation
- •depressive episode secondary to somatic disease or substance dependency
- •contraindication for olanzapine
- •treatment with interacting substances (CYP1A2 inhibitors or inductors)
- •comorbidity according to DSM-IV, axis I
- •denail of consent
- •hospital treatment by legal order
- •hepatic insufficiency
- •severe neurological or medical disease
- •adipositas permagna
- •HIV-infection
- •active viral hapatitis
研究组 & 干预措施
1
Active Comparator
Olanzapine 5 mg / day
干预措施: Olanzapine (Drug)
2
Placebo Comparator
Placebo
干预措施: Olanzapine (Drug)
结局指标
主要结局
Relapse Rate, Hamilton Depression Rating Scale (17 item version)
时间窗: 6 months
次要结局
- Safety and side effect scales (SWN Scale, CGI), Beck Depression Inventory(6 months)
研究者
Arnim Quante
Head of Affective Disorders Section
Charite University, Berlin, Germany
研究点 (1)
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