Clinical trial NCT02210962: Omega-3 Fatty Acids Efficacy in First-episode of Schizophrenia
Official title: Omega-3 Fatty Acids in First-episode Schizophrenia - a Randomized Controlled Study of Efficacy and Relapse Prevention (OFFER). Rationale, Design, and Methods.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Schizophrenia
Keywords: early psychosis
chronic schizophrenia
first episode psychosis
omega-3 and omega-6 essential fatty acids
relapse prevention
efficacy
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2014-08-07
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: The primary outcome measure will be the efficacy of n-3 PUFA in reducing psychopathology in first-episode schizophrenia.
timeFrame: 8 and 26 weeks of supplementation
Secondary outcomes:
measure: Relapse rate - Positive and Negative Syndrome Scale (PANSS) defined schizophrenia relapse
timeFrame: 26 weeks intervention plus 26 weeks observation
measure: PANSS total, positive, negative and general psychopathology subscales
timeFrame: Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks
measure: Calgary Depression Scale for Schizophrenia (CDSS)
timeFrame: Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks
measure: Clinical Global Impression (CGI)
timeFrame: Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks
measure: Global Assessment of Functioning (GAF)
timeFrame: Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks
measure: A white matter directional organization metric: fractional anisotropy (FA) measured in two areas: corpus callosum and uncinate fasciculus
timeFrame: Baseline, 26 weeks
measure: Cognitive performance using composite battery of neuropsychologic tests
timeFrame: Baseline, 8 and 26 weeks
measure: Niacin Flush Skin Test
timeFrame: Baseline, 8 and 26 weeks
measure: Side effects profile according to self-prepared questionnaire
timeFrame: Baseline, 4, 8, 26
measure: Lymphocyte telomerase activity
timeFrame: Baseline, 8 and 26 weeks
measure: Equivalent doses of antipsychotics used
timeFrame: Baseline, 1, 2, 4, 6, 8, 16, 26 and 52 weeks
measure: Grey matter volume: a voxel based structural MRI assessment
timeFrame: Baseline, 8 and 26 weeks
Other outcomes:
measure: Plasma cholesterol and Triglycerides
timeFrame: Baseline, 1, 2, 4, 6, 8, 26 and 52 weeks
measure: Blood pressure
timeFrame: Baseline, 1, 2, 4, 6, 8, 26 and 52 weeks
measure: Body mass index (BMI)
timeFrame: Baseline, 1, 2, 4, 6, 8, 26 and 52 weeks
measure: Waist circumference
timeFrame: Baseline, 1, 2, 4, 6, 8, 26 and 52 weeks
measure: Fasting glucose levels
timeFrame: Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks
Locations:
city: Lodz
country: Poland
facility: Department of Affective and Psychotic Disorders Medical University of Lodz
Study officials:
affiliation: Department of Affective and Psychotic Disorders Medical University of Lodz
name: Tomasz P Pawełczyk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.