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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
80
Yellow capsules containing eicosapentaenoic acid, docosahexaenoic acid (active)
Yellow capsules containing olive oil (placebo)
Department of Affective and Psychotic Disorders Medical University of Lodz
Lodz, Łódź Voivodeship, Poland
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.
Time frame: 8 and 26 weeks of supplementation
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
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