utraceuticals as Monotherapy Treatments in Major Depressive Disorder: A Double-Blind, Randomised, Placebo-Controlled Trial

Phase 2

Completed

• Conditions: Depression; Mental Health - Depression

• Registration Number: ACTRN12613001299796
• Lead Sponsor: niversity of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity of depressive symptoms measured with the Montgomery-Asberg Depression Rating Scale (MADRS)[Measured at baseline and weeks 2, 4, 6, and 8]

Secondary Outcome Measures

Name	Time	Method
Severity of self-reported depressive symptoms measured with the Beck Depression Inventory-II (BDI-II)[Measured at baseline and weeks 2, 4, 6, and 8];Health-related quality of life measured with the Short Form-12 (SF-12)[Measured at baseline and weeks 2, 4, 6, and 8];Symptom severity and global improvement measured with the Clinical Global Impression-Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I) scales[Measured at baseline and weeks 2, 4, 6, and 8];The CORE Assessment of Psychomotor Change[Measured at baseline and week 8];Anxiety measured with the Hamilton Anxiety Rating Scale (HAM-A)[Measured at baseline and weeks 2, 4, 6, and 8];Self-reported quality of sleep measured with the Leeds Sleep Evaluation Questionnaire (LSEQ)[Measured at baseline and weeks 2, 4, 6, and 8]