Adjunctive simvastatin treatment in schizophrenia patients; a double blind randomized and placebo controlled trial

Abstract

Introduction: Statins such as simvastatin are recently introduced as agents that may have beneficial effects in schizophrenia regarding their prominent anti-inflammatory properties. Objectives: This study was designed to evaluate the effects of simvastatin on schizophrenia symptoms. Patients and Methods: In a double-blinded randomized clinical trial, 40 hospitalized schizophrenia patients (according to the DSM-IV-TR criteria) were studied for 6 weeks. One group of the patients (n=20) received simvastatin (with the dose of 40 mg/d) and the other group received (n=20) placebo. The patients were evaluated by the Positive and Negative Syndrome Scale (PANSS) for schizophrenia symptoms. Data were analyzed with mixed model repeated measure ANOVA, t test, and χ2 test or Fischer’s exact test by SPSS software. The significant cutoff was considered at P<0.05. Results: The mean age of the patients was 34.05±9.74 years and 50% of them were men. There was not a significant difference between the two groups regarding negative symptoms reduction. Conclusion: Our study demonstrated that adding simvastatin on atypical antipsychotic treatment had no significant beneficial effects on the negative and positive symptoms in patients with schizophrenia disorder. Trial Registration: The trial protocol was approved by the Iranian Registry of Clinical Trials (identifier: IRCT2017052034046N1; https://en.irct.ir/trial/26134, ethical code; ETH-457).