NCT02210962

Omega-3 Fatty Acids Efficacy in First-episode of Schizophrenia

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Medical University of Lodz · Academic / Other
• Sex: All
• Age: 16 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	essential fatty acids	Yellow capsules containing eicosapentaenoic acid, docosahexaenoic acid (active)
DIETARY_SUPPLEMENT	olive oil	Yellow capsules containing olive oil (placebo)

Timeline

• Start date: 2011-09-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2014-08-07
• Last updated: 2015-02-18

Locations

1 site across 1 country: Poland