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

Phase 4

• Conditions: Schizophrenia
• Interventions: Dietary Supplement: essential fatty acids; Dietary Supplement: olive oil

• Registration Number: NCT02210962
• Lead Sponsor: Medical University of Lodz

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2014-08-05
• Study First Submitted QC: 2014-08-05
• Study First Posted: 2014-08-07
• Status Verified: 2015-02
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Last Update Submitted: 2015-02-16
• Last Update Posted: 2015-02-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
essential fatty acids	essential fatty acids	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
olive oil	olive oil	Placebo capsules contain olive oil and trace amount of fish oil to assure comparable taste, 26 weeks intervention

Primary Outcome Measures

Name	Time	Method
The primary outcome measure will be the efficacy of n-3 PUFA in reducing psychopathology in first-episode schizophrenia.	8 and 26 weeks of supplementation	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.

Secondary Outcome Measures

Name	Time	Method
Calgary Depression Scale for Schizophrenia (CDSS)	Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks
Clinical Global Impression (CGI)	Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks
PANSS total, positive, negative and general psychopathology subscales	Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks
Relapse rate - Positive and Negative Syndrome Scale (PANSS) defined schizophrenia relapse	26 weeks intervention plus 26 weeks observation
Niacin Flush Skin Test	Baseline, 8 and 26 weeks
Equivalent doses of antipsychotics used	Baseline, 1, 2, 4, 6, 8, 16, 26 and 52 weeks
Side effects profile according to self-prepared questionnaire	Baseline, 4, 8, 26
Cognitive performance using composite battery of neuropsychologic tests	Baseline, 8 and 26 weeks
Global Assessment of Functioning (GAF)	Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks
Lymphocyte telomerase activity	Baseline, 8 and 26 weeks
A white matter directional organization metric: fractional anisotropy (FA) measured in two areas: corpus callosum and uncinate fasciculus	Baseline, 26 weeks
Grey matter volume: a voxel based structural MRI assessment	Baseline, 8 and 26 weeks

Trial Locations

Locations (1)

Department of Affective and Psychotic Disorders Medical University of Lodz; 🇵🇱 Lodz, Poland