80
Participants
Start Date
June 30, 2014
Primary Completion Date
June 30, 2016
Study Completion Date
June 30, 2016
omega-3 PUFAs
4 capsules (2 in the morning; 2 in the evening) for a period of 12 weeks. The active treatment is a supplement of yellow gelatine 0.625 g capsules containing concentrated marine fish oil. The daily dose of 4 capsules will provide approximately 700 mg of eicosapentaenoic acid (EPA, 20:5n3), 480 mg of docosahexaenoic acid (DHA, 22:6n3), and 7.6 mg of Vitamin E.
Standard care
Standard care includes management by a psychiatrist or resident psychiatrist and non-neuroleptic pharmacotherapy as clinically indicated. Specifically, Cognitive-behavioural therapy (CBT) embedded within case management will be administered. The CBT will be based on the models developed at the PACE Clinic in Melbourne, in the EDIE trial, and in Cologne, as these have proven to be effective in RCTs. The number of sessions delivered will be captured for each client. In addition, fidelity will be monitored by therapists rating their own sessions on an established checklist of therapeutic interventions.
placebo
4 capsules of 0.7g of paraffin oil (which is not absorbed by the gastrointestinal tract) per day.
Bambino Gesù Hospital and Research Institute, Vatican City
Collaborators (1)
National Alliance for Research on Schizophrenia and Depression
OTHER
Orygen
OTHER
Bambino Gesù Hospital and Research Institute
OTHER