utraceuticals as Adjunctive Treatments in Major Depressive Disorder (NAT-D): A Double-Blind, Randomised, Placebo-Controlled Trial

Phase 3

Completed

• Conditions: Depression; Mental Health - Depression

• Registration Number: ACTRN12613001300763
• 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: 300

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.

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]