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

• Register: ClinicalTrials.gov
• Last refreshed on: 2 March 2015
• Main ID: NCT02210962
• Date of registration: 05/08/2014
• Prospective Registration: No
• Primary sponsor: Medical Universtity of Lodz
• Public title: Omega-3 Fatty Acids Efficacy in First-episode of Schizophrenia OFFER
• Scientific title: Omega-3 Fatty Acids in First-episode Schizophrenia - a Randomized Controlled Study of Efficacy and Relapse Prevention (OFFER). Rationale, Design, and Methods.
• Date of first enrolment: September 2011
• Target sample size: 80
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT02210962
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
• Phase: Phase 4

Countries of recruitment

Poland

Contacts

• Name: Tomasz P Pawelczyk, MD, PhD
• Affiliation: Department of Affective and Psychotic Disorders Medical University of Lodz

Key inclusion & exclusion criteria

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



Age minimum: 16 Years
Age maximum: 35 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Schizophrenia

Intervention(s)

Dietary Supplement: olive oil

Dietary Supplement: essential fatty acids

Primary Outcome(s)

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

Secondary Outcome(s)

A white matter directional organization metric: fractional anisotropy (FA) measured in two areas: corpus callosum and uncinate fasciculus [Time Frame: Baseline, 26 weeks]

Global Assessment of Functioning (GAF) [Time Frame: Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks]

PANSS total, positive, negative and general psychopathology subscales [Time Frame: Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks]

Equivalent doses of antipsychotics used [Time Frame: Baseline, 1, 2, 4, 6, 8, 16, 26 and 52 weeks]

Grey matter volume: a voxel based structural MRI assessment [Time Frame: Baseline, 8 and 26 weeks]

Side effects profile according to self-prepared questionnaire [Time Frame: Baseline, 4, 8, 26]

Calgary Depression Scale for Schizophrenia (CDSS) [Time Frame: Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks]

Clinical Global Impression (CGI) [Time Frame: Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks]

Lymphocyte telomerase activity [Time Frame: Baseline, 8 and 26 weeks]

Cognitive performance using composite battery of neuropsychologic tests [Time Frame: Baseline, 8 and 26 weeks]

Relapse rate - Positive and Negative Syndrome Scale (PANSS) defined schizophrenia relapse [Time Frame: 26 weeks intervention plus 26 weeks observation]

Niacin Flush Skin Test [Time Frame: Baseline, 8 and 26 weeks]

Secondary ID(s)

N N402 243435

Source(s) of Monetary Support

Please refer to primary and secondary sponsors