Sequence Towards Remission in Depression
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Montgomery-Åsberg rating scale
研究概览
简要总结
In this study the investigators use clinical, biological and imaging markers to develop predictive markers for remission from depression. The investigators compare individuals who have received placebo to individuals who have received 10 mg of escitalopram for one week. In this double-blind, randomized study the investigators a) compare the groups to observe the short-term effects of escitalopram and b) study the predictive value of these observations with respect to remission. Measures include, but are not restricted to, limbic emotional reactivity as assessed by fMRI, emotional processing, emotional memory, autobiographical memory.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major depressive disorder with current major depressive episode according to a SCID-I/P interview
- •Montgomery-Åsberg depression rating score 15-30
- •Age 18-60
排除标准
- •Borderline, schizoid or schizotypal personality, bipolar or any psychotic disorder
- •Primary diagnosis is anxiety disorder: 300.00, .01, .02, .21, .22, .29, .23, .3, 309.81, 308.3, 293.89
- •Significant current suicidal ideation, or history of a suicide attempt
- •Lifetime substance dependence; Last-year substance abuse; Last month over 24/16 standard doses of alcohol/week; Lifetime use of illicit substances > x5; Any illicit substance use in last month
- •Depressive disorder due to medical condition or chemical substance
- •Antidepressant medication use in last 4 months
- •Severe, unstable somatic illness
- •Use of antipsychotics, mood stabilizers, systemic corticosteroids, β-blockers or daytime benzodiazepines (a small dose of ≤10mg zolpidem once daily is permissible)
研究组 & 干预措施
Placebo
Microgranular cellulose in gelatine capsules.
干预措施: Placebo (Drug)
Escitalopram 10 mg
Escitalopram in gelatine capsule
干预措施: escitalopram 10 mg (Drug)
结局指标
主要结局
Montgomery-Åsberg rating scale
时间窗: 7 weeks
次要结局
未报告次要终点
研究者
Jesper Ekelund
Professor of Psychiatry
University of Helsinki