BackgroundPolyunsaturated fatty acid (PUFA) metabolism abnormalities have been long implicated in the etiology of schizophrenia. Although several randomized clinical trials have been carried out to assess the efficacy of omega-3 PUFA as add-on therapy in reducing psychopathology in populations of chronic patients with schizophrenia, only a few concern first-episode schizophrenia. The majority of these studies used a 12-week intervention based on ethyl-eicosapentaenoic acid (ethyl-EPA), however, with conflicting results. An intervention based on docosahexaenoic acid plus EPA has not been used in first-episode schizophrenia studies so far. No add-on supplementation studies have been carried out in medicated first-episode schizophrenia patients to assess the efficacy of omega-3 PUFA in preventing relapses.MethodsA randomized placebo-controlled one-center trial will be used to compare the efficacy of 26-week intervention, composed of either 1320 mg/day of EPA and 880 mg/day of DHA, or olive oil placebo with regard to symptom severity and relapse rate in first-episode schizophrenia patients. Eighty-two patients (aged 16–35) will be recruited for the study. Eligible patients will be randomly allocated to one of two intervention arms: an active arm or a placebo arm (olive oil). The primary outcome measure of the clinical evaluation is schizophrenia symptom severity measured by the Positive and Negative Syndrome Scale (PANSS). Other outcomes include depressive symptoms, patient functioning and the level of insight. Correlates of change measured during the study will include structural brain changes, oxidative stress and defense, as well as neuroplasticity indicators. Metabolic syndrome components will also be assessed throughout the study.DiscussionBy comparing 26-week administration of EPA + DHA or (placebo) olive oil as add-on therapy in reducing symptom severity and one-year relapse rate in patients with first episode schizophrenia, it is intended to provide new insights into the efficacy of omega-3 PUFA and correlates of change, and contribute to the improvement of mental health care for individuals suffering from schizophrenia.Trial registrationThis study has been registered at Clinical Trials.gov with the following number: NCT02210962.
Introduction: Omega-3 polyunsaturated fatty acids (n3-PUFA) are major constituents of the neural membranes. N-3 PUFA take part in several neuronal mechanisms, including modulation and control of neurobiological processes, such as ion channel and receptor activity, neurotransmitter release, synaptic plasticity, second messenger pathways and neuronal gene expression. Deficiency in n-3 PUFA has been postulated in the etiology of schizophrenia. Intervention trials supplementing n-3 PUFA were conducted to assess the efficacy of n-3 PUFA in reducing symptom severity in exacerbations of chronic schizophrenia and acute phase of first-episode schizophrenia. The results were n-3 PUFA were found to prevent conversion to psychosis in clinical high risk populations. Objectives: To assess the efficacy n-3 PUFA as add-on treatment in relapse prevention in first-episode schizophrenia patients. Methods: We conducted a randomized, double-blind, placebo-controlled, parallel-group single-center 6 months augmentation trial of either 2,2 g per day of n-3 PUFA or placebo added on to an adjustable dose of antipsychotic medication in first-episode schizophrenia patients. Intervention was composed of either 1320 mg/day of eicosapentaenoic acid plus 880 mg/day of docosahexaenoic acid or placebo olive oil. The relapse rate was observed during a follow up period of 12 months. Results: 71 patients completed the study (41% female). Relapse was observed in 4 patients (11.4%) enrolled in n-3 PUFA group and 12 patients (33.3%) in placebo group over a period of 12 months. The difference was statistically significant (log rank test, p=0.0225). Conclusions: The results indicate, that n-3 PUFA add-on therapy can effectively prevent relapses in firstepisode schizophrenia patients.
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