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

Schizophrenia Clinical Trial

— OFFER  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02210962
• Other study ID #: N N402 243435
• Status: Active, not recruiting
• Phase: Phase 4
• First received: August 5, 2014
• Last updated: February 16, 2015
• Start date: September 2011
• Est. completion date: February 2015

Study information

• Verified date: February 2015
• Source: Medical Universtity of Lodz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Science and Higher Education
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Dietary Supplement:
• essential fatty acids
Yellow capsules containing eicosapentaenoic acid, docosahexaenoic acid (active)
• olive oil
Yellow capsules containing olive oil (placebo)

Locations

Country	Name	City	State
Poland	Department of Affective and Psychotic Disorders Medical University of Lodz	Lodz

Sponsors (1)

Lead Sponsor	Collaborator
Medical Universtity of Lodz

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Plasma cholesterol and Triglycerides		Baseline, 1, 2, 4, 6, 8, 26 and 52 weeks	Yes
Other	Blood pressure		Baseline, 1, 2, 4, 6, 8, 26 and 52 weeks	Yes
Other	Body mass index (BMI)		Baseline, 1, 2, 4, 6, 8, 26 and 52 weeks	Yes
Other	Waist circumference		Baseline, 1, 2, 4, 6, 8, 26 and 52 weeks	Yes
Other	Fasting glucose levels		Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks	Yes
Primary	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	No
Secondary	Relapse rate - Positive and Negative Syndrome Scale (PANSS) defined schizophrenia relapse		26 weeks intervention plus 26 weeks observation	No
Secondary	PANSS total, positive, negative and general psychopathology subscales		Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks	No
Secondary	Calgary Depression Scale for Schizophrenia (CDSS)		Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks	No
Secondary	Clinical Global Impression (CGI)		Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks	No
Secondary	Global Assessment of Functioning (GAF)		Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks	No
Secondary	A white matter directional organization metric: fractional anisotropy (FA) measured in two areas: corpus callosum and uncinate fasciculus		Baseline, 26 weeks	No
Secondary	Cognitive performance using composite battery of neuropsychologic tests		Baseline, 8 and 26 weeks	No
Secondary	Niacin Flush Skin Test		Baseline, 8 and 26 weeks	No
Secondary	Side effects profile according to self-prepared questionnaire		Baseline, 4, 8, 26	Yes
Secondary	Lymphocyte telomerase activity		Baseline, 8 and 26 weeks	No
Secondary	Equivalent doses of antipsychotics used		Baseline, 1, 2, 4, 6, 8, 16, 26 and 52 weeks	No
Secondary	Grey matter volume: a voxel based structural MRI assessment		Baseline, 8 and 26 weeks	No