None listed
Conditions
Brief summary
Long-chain omega-3 polyunsaturated fatty acids (PUFAs) play an important role in a range of physiological processes in all living organisms. Supplementation with omega-3 PUFAs has been shown to have range of beneficial effects on both physical and mental health, while results of previous trials in child and adult populations suggest that omega-3 PUFAs may offer a safe and effective treatment for depression. However, conclusions from these trials have been limited by their relatively small sample sizes. This study aims to test the therapeutic effects of a 12-week randomised, placebo controlled trial of approximately 1.4 grams/day omega-3 fatty acids in 300 help-seeking 15 to 25 year olds presenting with moderate to severe major depressive disorder (MDD). The primary hypothesis is that young people with moderate-to-severe MDD will show greater improvement after 12 weeks of treatment with omega-3 PUFAs plus cognitive behavioural case management (CBCM) compared to treatment with placebo plus CBCM. The primary outcome measure is change in the Quick Inventory of Depression Symptomatology (QIDS-A17-C) score. The secondary hypotheses include the rate of remission (defined as patients not meeting the criteria for MDD at 12 weeks and 6 months) will be greater for young people treated with omega-3 PUFAs plus CBCM compared to treatment with placebo plus CBCM.
Interventions
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.
Sponsors
Orygen Youth Health Research Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
15 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
1) Aged 15-25 years help seeking for psychological distress. 2) A score between 11 and 20 on the QIDS-A17-C at first contact with the service AND after 1 week (plus 1-5 days if the client is unable to attend earlier) at the second assessment, or at 2 subsequent (weekly) follow-up assessments. 3) A diagnosis of major depressive disorder using the Structured Clinical Interview for DSM-IV Axis I Disorders, patient version (SCID-I/P). 4) Written informed consent (for individuals under 18, written informed consent of at least one parent or a guardian is required).
Exclusion criteria
1) Lifetime diagnosis or history of treatment for psychotic disorder or bipolar disorder or substance dependence (assessed with a brief, self-developed checklist). 2) History of treatment with an antidepressant (more than four weeks during the last 12 months, upon review of medical history). 3) Acute suicidal behaviour as assessed by a score of 6 on the Comprehensive Assessment of At Risk Mental States (CAARMS; item 7.3) or aggressive behaviour (score of 6 on CAARMS item 5.4). 4) Depression secondary to a medical condition. 5) IQ<70 as per medical history review. 6) Pregnancy or lactation. 7) Laboratory values more than 15% outside the normal range for bleeding parameters. 8) Individuals who are taking omega-3 supplements or psychotropic medication, currently or within 8 weeks of being included in the trial, for more than 1 week continuously. 9) Known allergy to omega-3s or any ingredients in the investigational product.
Outcome results
None listed