ACTRN12613001300763CompletedPhase 3
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 sites300 target enrollmentStarted: November 22, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 300
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (—)
- Sex
- All
Inclusion Criteria
- •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)
Exclusion Criteria
- •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.
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