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临床试验/ACTRN12613001300763
ACTRN12613001300763已完成3 期

The Efficacy of S-Adenosyl Methionine (SAMe) and a Combination Nutraceutical as Adjunctive Treatments in Major Depressive Disorder: A Double-Blind, Randomised, Placebo-Controlled Trial

niversity of Melbourne0 个研究点目标入组 300 人开始时间: 2013年11月22日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
300

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 75 Years(—)
性别
All

入选标准

  • Aged 18 to 75;
  • 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 depression (MADRS = or > 18) at time of study entry;
  • meets SAFER 2.0 criteria for a stable episode of depression;
  • currently taking one of the following antidepressants for a minimum of four weeks, and on a stable dose for a minimum of two weeks: agomelatine (= or > 25 mg/day), citalopram (= or > 20 mg/day), desvenlafaxine (= or > 25mg/day), duloxetine (= or > 60 mg/day), escitalopram (= or > 10 mg/day), fluoxetine (= or > 20 mg/day), fluvoxamine (= or > 50 mg/day), mirtazapine (= or > 30 mg/day), paroxetine (= or > 20 mg/day), reboxetine (= or > 8 mg/day), sertraline (= or > 50 mg/day), venlafaxine (= or > 150 mg/day)

排除标准

  • Currently taking MAOIs or tricylic antidepressants;
  • 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 (> 3 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 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.

研究者

发起方
niversity of Melbourne

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