This trial is active, not recruiting.

Condition schizophrenia
Treatments essential fatty acids, olive oil
Phase phase 4
Sponsor Medical Universtity of Lodz
Start date September 2011
End date February 2015
Trial size 80 participants
Trial identifier NCT02210962, N N402 243435


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
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
essential fatty acids
Yellow capsules containing eicosapentaenoic acid, docosahexaenoic acid (active)
(Placebo Comparator)
Placebo capsules contain olive oil and trace amount of fish oil to assure comparable taste, 26 weeks intervention
olive oil
Yellow capsules containing olive oil (placebo)

Primary Outcomes

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 Outcomes

Relapse rate - Positive and Negative Syndrome Scale (PANSS) defined schizophrenia relapse
time frame: 26 weeks intervention plus 26 weeks observation
PANSS total, positive, negative and general psychopathology subscales
time frame: Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks
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
Global Assessment of Functioning (GAF)
time frame: 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
time frame: Baseline, 26 weeks
Cognitive performance using composite battery of neuropsychologic tests
time frame: Baseline, 8 and 26 weeks
Niacin Flush Skin Test
time frame: Baseline, 8 and 26 weeks
Side effects profile according to self-prepared questionnaire
time frame: Baseline, 4, 8, 26
Lymphocyte telomerase activity
time frame: Baseline, 8 and 26 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

Eligibility Criteria

Male or female participants from 16 years up to 35 years old.

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

Additional Information

Official title Omega-3 Fatty Acids in First-episode Schizophrenia - a Randomized Controlled Study of Efficacy and Relapse Prevention (OFFER). Rationale, Design, and Methods.
Principal investigator Tomasz P Pawełczyk, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Medical Universtity of Lodz.