Not Yet RecruitingPhase 4ACTRN12610000710022

An 8 week randomised, double-blind, placebo controlled trial investigating the role of adjunctive bioactive lipids specifically; docosahexaenoic acid (DHA) versus eicosapentaenoic acid (EPA) in Major Depressive Disorder - with a 6 week open label extension of DHA in patients aged 18-65years.


Sponsor

The Melbourne Clinic

Enrollment

90 participants

Start Date

Oct 1, 2010

Study Type

Interventional

Conditions

Summary

The primary objective is to evaluate the effectiveness of DHA versus placebo and compare the difference between DHA and EPA on the symptoms of depression. Effectiveness will be measured by the mean change in total scores on the HAM-D from baseline to double-blind end point at week 8. Patients with a 50% reduction in HAM-D scores or who have a score equal to or less than 8 will be considered to be in full remission whilst patients with a score of 12 or less will be considered to have improved; (from baseline to Week 8 or dropout). A secondary aim of the study will be to compare the levels of BDNF at baseline and at the completion of the double-blind phase of the study in the patients treated with DHA versus the comparator EPA and placebo. An additional aim will be to measure the change from baseline in cognitive functioning using a brief cognitive battery which assess 5 cognitive domains. Mean change from baseline scores to week 8 will also be used to measure patients Global Assessment of Functioning, sleep and levels of suicidal ideation using Item 3 on the HAM-D.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether fish oil supplements (DHA or EPA) can help treat major depression when added to standard treatment. You must be aged 18 to 65 and have a diagnosis of major depressive disorder. People with other serious mental or neurological illnesses cannot participate.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Patients in the DHA arm of the study will be given 2 tablets (260 mg/day) of supplementary DHA and patients in the EPA arm will be required to take 2 tablets or 360mg of EPA; patients in the placebo

Patients in the DHA arm of the study will be given 2 tablets (260 mg/day) of supplementary DHA and patients in the EPA arm will be required to take 2 tablets or 360mg of EPA; patients in the placebo arm will be required to take 2 tablets or 2000mg of sunflower oil. At the completion of the double-blind period (8 weeks) all participants will be switched to DHA (260mg/day) for a 6 week open label extension. In addition and where possible patient’s background antidepressant medication will remain as a fixed dose for the 8 week study period


Locations(1)

Australia

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ACTRN12610000710022


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