Omega-3 Fatty Acids Efficacy in First-episode of Schizophrenia (OFFER)

Omega-3 Fatty Acids in First-episode Schizophrenia - a Randomized Controlled Study of Efficacy and Relapse Prevention (OFFER). Rationale, Design, and Methods.

There is accumulating experimental evidence to suggest the role of essential fatty acids (EFA) in neuronal migration, pruning and synaptic plasticity. These processes are implied to be dysfunctional on early stages of schizophrenia, according to neurodevelopmental hypothesis. Numerous epidemiological and clinical trial data support the benefit of EFA rich diets in reducing symptoms in schizophrenia. An EFA rich diet might be of particular importance at the beginning of the illness. As a relatively safe option, EFA supplementation would be a preferable add on therapy in treating individuals with a first episode of schizophrenia (FES) and a short duration of psychotic symptoms. No long term follow-up studies of EFA supplementation in FES patients were carried out. The demonstration of the efficacy of the prophylactic properties of EFAs in relapse prevention in FES patients would be a strong basis for further studies and prescribing EFAs for a large population of patients who are in the early stages of that debilitating illness.

early psychosis, chronic schizophrenia, first episode psychosis, omega-3 and omega-6 essential fatty acids, relapse prevention, efficacy

The experimental treatment is a food supplement containing fish oil. The daily dose of 4 capsules provides 1320 mg of eicosapentaenoic acid and 880 mg of docosahexaenoic acid, 26 weeks intervention

Placebo capsules contain olive oil and trace amount of fish oil to assure comparable taste, 26 weeks intervention

The primary outcome measure will be the efficacy of n-3 PUFA in reducing psychopathology in first-episode schizophrenia.

The Positive and Negative Syndrome Scale [64] will be used to assess the efficacy of EPA+DHA supplementation in reducing symptom severity in first-episode schizophrenia after 8 and 26 weeks of supplementation. The main outcome measure will be the change in symptom severity from baseline to week 26. Baseline PANSS total score will be subtracted from PANSS score obtained after 26 weeks, resulting in the degree of change observed in the study.

A white matter directional organization metric: fractional anisotropy (FA) measured in two areas: corpus callosum and uncinate fasciculus

Inclusion Criteria: Patients diagnosed with schizophrenia using Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria Patients aged between 16-35 years Signed informed consent (parallel parents consent for individuals under 18 years of age) Exclusion Criteria: Patients taking fish oil supplements (a washout period of 6 months is required) Patients diagnosed with epilepsy or suffering from epileptic seizures Patients receiving anticoagulant medication e.g., Warfarin Patients receiving psychotherapy Chronic somatic diseases Psychoactive substance dependence Pregnancy and lactation Mental retardation or diagnosed organic brain injury

Pawelczyk T, Grancow M, Kotlicka-Antczak M, Trafalska E, Gebski P, Szemraj J, Zurner N, Pawelczyk A. Omega-3 fatty acids in first-episode schizophrenia - a randomized controlled study of efficacy and relapse prevention (OFFER): rationale, design, and methods. BMC Psychiatry. 2015 May 2;15:97. doi: 10.1186/s12888-015-0473-2.