Youth Depression Alleviation: A randomised controlled trial of omega-3 fatty acids (fish oil) for major depressive disorder in young people (YoDA-F)

Intervention

Intervention code Behaviour , Treatment: Other

Participants will receive either long-chain omega-3 fatty acids or placebo for 12 weeks. All participants will receive cognitive behavioural case management (CBCM). Long-chain omega-3 fatty acids / placebo treatment will commence at week 0. CBCM sessions will commence at approximately week 2. Cognitive behavioural case management (CBCM): Participants are expected to receive 5 sessions of CBCM. The CBCM intervention consists of cognitive-behavioural therapy (CBT) embedded within case management. .... Participants will receive either long-chain omega-3 fatty acids or placebo for 12 weeks. All participants will receive cognitive behavioural case management (CBCM). Long-chain omega-3 fatty acids / placebo treatment will commence at week 0. CBCM sessions will commence at approximately week 2. Cognitive behavioural case management (CBCM): Participants are expected to receive 5 sessions of CBCM. The CBCM intervention consists of cognitive-behavioural therapy (CBT) embedded within case management. The treating clinicians will use a specifically developed manual that details the CBCM to be delivered in the trial, and which outlines the minimum standard of treatment to be delivered. CBCM sessions will be of 50 minutes duration, and will be scheduled on a fortnightly basis (at approximately Weeks 2, 4, 6, 8, 10). The total number of CBCM sessions delivered will be captured for each client. The maximum number of CBCM sessions to be provided is 5. Additional sessions for crisis management will be provided if necessary. In addition, fidelity will be monitored by therapists rating their own sessions on an established checklist of therapeutic interventions. Any additional interventions delivered will also be documented. The case management component will consist of therapists addressing current interpersonal and social issues. Active treatment - omega-3 fatty acids: The active treatment is a supplement containing concentrated marine fish oil. The daily dose of 4 capsules will provide approximately 840 mg of eicosapentaenoic acid (EPA), approximately 560 mg of docosahexaenoic acid (DHA), and approximately 5 mg of Vitamin E. Vitamin E is added as an antioxidant to fish oil capsules to stabilize highly unsaturated fatty acids. Participants will receive either 4 capsules of marine fish oil or 4 capsules of approximately 700 mg of paraffin oil (which is not absorbed by the gastrointestinal tract) per day. The daily dose omega-3 fatty acids is based on previous trials in major depression. Patient compliance will be assessed by monthly pill counts over the course of the study, as well as through self report and the measurement of the fatty acid composition of red blood cell membranes from blood samples collected at baseline and 12 weeks after study entry. The blood samples will be stored frozen for batched analysis. The results of the fatty acid analysis will not be revealed to the investigator until the end of the study.
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Comparison

Control group Placebo

Placebo: The placebo are capsules matched in appearance and taste to the active treatment. Placebo capsules contain paraffin oil, chosen as it does not contain polyunsaturated fatty acids and has no impact on omega-3 fatty acid metabolism. To ensure blinding, placebo capsules will be carefully matched in appearance and flavour with the active treatment; they will also contain the same amount of Vitamin E as the fish oil capsules, and approximately 1% fish oil to mimic taste.

Outcomes

Outcome: Change in depressive symptoms at end of oral intervention phase (12 weeks), as assessed by the 17-item clinician-rated Quick Inventory of Depression Symptoms - Adolescent Version (QIDS-A17-C).
Timepoint: Change in QIDS-A17-C scores, between baseline and 12 weeks or the time point when a subject exits the study.