A Multicentre 12-week Randomised, Double Blind, Placebo Controlled Trial of Simvastatin as Augmentation Treatment for Treatment-resistant Depression
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Montgomery-Asberg Depression Rating Scale (MADRS; Montgomery Asberg, 1979)
研究概览
简要总结
In this double blind, randomized placebo controlled trial we aim to determine the efficacy of simvastatin as an add-on treatment for treatment resistant depression. We will recruit 150 people with treatment-resistant depression with the aim of determining whether the addition of simvastatin (20mg daily) to treatment as usual (TAU) for 12 weeks leads to an improvement in depressive symptom compared with placebo added to TAU.
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)
盲法说明
Double blind plcaebo controlled trial
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-5 current major depressive episode
- •Must currently be on an antidepressant and must have had a non-response to >2 oral antidepressant treatments in the current episode (including the one they are currently taking).
- •Capacity to give informed consent
- •Willing to use adequate contraception
- •Give written informed consent
排除标准
- •Primary psychotic or bipolar disorder
- •History of intolerance to statins or presence of any contraindication to statins
- •Presence of any serious medical condition or neurological problem
- •Presence of autoimmune or inflammatory disorder
- •Alcohol or drug dependence
- •Active suicidal ideation
- •Pregnant or breast-feeding.
研究组 & 干预措施
Simvastatin with TAU
Participants will receive Simvastatin 20 mg added to TAU for 3 months
干预措施: Simvastatin 20 mg (Drug)
Placebo Oral Tablet with TAU
Participants will receive placebo added to TAU for 3 months
干预措施: Placebo Oral Tablet (Other)
结局指标
主要结局
Montgomery-Asberg Depression Rating Scale (MADRS; Montgomery Asberg, 1979)
时间窗: Week-2, Week-4, Week-8 and Week-12
The MADRS will be used as primary outcome measure in estimating depression severity
次要结局
未报告次要终点