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

Medical University of Lodz

Status and phase: Unknown; Phase 4

Conditions: Schizophrenia

Treatments: Dietary Supplement: olive oil; Dietary Supplement: essential fatty acids

Study type: Interventional

Funder types: Other

Identifiers

NCT02210962

N N402 243435

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 16 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

essential fatty acids

Experimental group

Description:

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

Treatment:

Dietary Supplement: essential fatty acids

olive oil

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: olive oil