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.

Study Overview

• Status: Unknown
• Conditions: Schizophrenia
• Intervention / Treatment: Dietary supplement: essential fatty acids; Dietary supplement: olive oil

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • Lodz, Poland, 92216
    • Department of Affective and Psychotic Disorders Medical University of Lodz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 35 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Dietary supplement: essential fatty acids; Yellow capsules containing eicosapentaenoic acid, docosahexaenoic acid (active)
Placebo Comparator: olive oil; Placebo capsules contain olive oil and trace amount of fish oil to assure comparable taste, 26 weeks intervention	Dietary supplement: olive oil; Yellow capsules containing olive oil (placebo)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 and 26 weeks of supplementation

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
Plasma cholesterol and Triglycerides	Baseline, 1, 2, 4, 6, 8, 26 and 52 weeks
Blood pressure	Baseline, 1, 2, 4, 6, 8, 26 and 52 weeks
Body mass index (BMI)	Baseline, 1, 2, 4, 6, 8, 26 and 52 weeks
Waist circumference	Baseline, 1, 2, 4, 6, 8, 26 and 52 weeks
Fasting glucose levels	Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks

Collaborators and Investigators

• Sponsor: Medical University of Lodz
• Investigators: Principal Investigator: Tomasz P Pawełczyk, MD, PhD, Department of Affective and Psychotic Disorders Medical University of Lodz

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Anticipated): February 1, 2015
• Study Completion (Anticipated): February 1, 2015

Study Registration Dates

• First Submitted: August 5, 2014
• First Submitted That Met QC Criteria: August 5, 2014
• First Posted (Estimate): August 7, 2014

Study Record Updates

• Last Update Posted (Estimate): February 18, 2015
• Last Update Submitted That Met QC Criteria: February 16, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: relapse prevention; efficacy; early psychosis; first episode psychosis; chronic schizophrenia; omega-3 and omega-6 essential fatty acids
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: N N402 243435