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
相似试验
已完成
2 期
utraceuticals as Monotherapy Treatments in Major Depressive Disorder: A Double-Blind, Randomised, Placebo-Controlled TrialDepressionACTRN12613001299796niversity of Melbourne60
尚未招募
不适用
(S)-S-adenosylmethionine (SAMe) in the treatment of pre-menstrual spectrum disorders in adult women: An open-label pilot studyPremenstrual Dysphoric DisorderMental Health - Other mental health disordersReproductive Health and Childbirth - Menstruation and menopausePremenstrual SyndromeACTRN12621001269820Alfred Health30
进行中（未招募）
不适用
Efficacy and safety of S-adenosil-methionine on depression of patients with Lesch - Nyhan Syndrome - NDEUCTR2007-004036-23-ITFONDAZIONE MALATTIE RARE MAURO BASCHIROTTO B.I.R.D. ONLUS
已完成
不适用
The use of a natural medicine, S-adenolsylmethionine (SAM-e) in the treatment of FibromyalgiaFibromyalgia Chronic Fatigue SyndromeMusculoskeletal - Other muscular and skeletal disordersFibromyalgiaChronic Fatigue SyndromeACTRN12607000485437Deakin University70
招募中
不适用
The use of a natural medicine, S-adenolsylmethionine (SAM-e) in the treatment of Fibromyalgia and Chronic Fatigue SyndromeMusculoskeletal - Other muscular and skeletal disordersChronic Fatigue SyndromeFibromyalgiaACTRN12607000377437Deakin University120