Indicated Prevention With Long-chain Polyunsaturated Omega-3 Fatty Acids in Patients With 22q11 Microdeletion Syndrome.

PHASE2/PHASE3UnknownINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

June 30, 2014

Primary Completion Date

June 30, 2016

Study Completion Date

June 30, 2016

Conditions
22q11 Deletion Syndrome
Interventions
DIETARY_SUPPLEMENT

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.

OTHER

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.

DIETARY_SUPPLEMENT

placebo

4 capsules of 0.7g of paraffin oil (which is not absorbed by the gastrointestinal tract) per day.

Trial Locations (1)

00165

Bambino Gesù Hospital and Research Institute, Vatican City

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Alliance for Research on Schizophrenia and Depression

OTHER

collaborator

Orygen

OTHER

lead

Bambino Gesù Hospital and Research Institute

OTHER

NCT02070211 - Indicated Prevention With Long-chain Polyunsaturated Omega-3 Fatty Acids in Patients With 22q11 Microdeletion Syndrome. | Biotech Hunter | Biotech Hunter