ACTRN12613001299796已完成2 期
The Efficacy of S-Adenosyl Methionine (SAMe) and a Combination Nutraceutical as Monotherapy Treatments in Major Depressive Disorder: A Double-Blind, Randomised, Placebo-Controlled Trial
niversity of Melbourne0 个研究点目标入组 60 人开始时间: 2013年11月22日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •Aged 18 to 70;
- •fluent in written and spoken English;
- •has the capacity to consent to the study and follow its procedures;
- •fulfills the DSM-IV-TR and DSM-5 diagnostic criteria for Major Depressive Disorder on structured interview (MINI-Plus);
- •presents with mild to moderate depression (MADRS 14-25) at time of study entry;
- •meets SAFER 2.0 criteria for a stable episode of depression.
排除标准
- •Currently taking any antidepressant medication (SSRIs, SNRIs, tricyclics, MAOIs, mood stabilisers, etc);
- •current use of any nutraceutical including a multi-vitamin, omega-3, or psychotropic herbal medicine e.g. St John’s wort (a two week washout can occur before inclusion);
- •presents with suicidal ideation ( >1 on MADRS suicidal thoughts domain) at time of study entry;
- •three or more failed trials of pharmacotherapy or somatic therapy (e.g. ECT, TMS) for the current major depressive episode;
- •recently commenced psychotherapy (>4 weeks of stable treatment acceptable);
- •taking warfarin or phenytoin;
- •diagnosis of bipolar disorder I/II or schizophrenia on structured interview (MINI-Plus);
- •a primary clinical diagnosis of a substance/alcohol use disorder within the last 12 months on structured interview (MINI-Plus);
- •known or suspected clinically unstable systemic medical disorder (including cancer, organ failure, or serious cardio/cerebrovascular disease);
- •pregnancy or breastfeeding;
- •not using medically approved contraception (including abstinence) if female and of childbearing age;
- •allergy to seafood.
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