Simvastatin adjunct therapy for negative symptoms of schizophrenia: a randomized double-blind placebo-controlled trial.

We investigated the effects of simvastatin adjunctive therapy on the negative symptoms of schizophrenia. In this double-blind trial, inpatients with chronic schizophrenia were clinically stabilized on a constant dose of risperidone for at least 4 weeks before the study and were then randomized to receive risperidone (4-6 mg/day) plus either simvastatin (40 mg/day) (n=33) or placebo (n=33) for 8 weeks. The Positive and Negative Syndrome Scale was used to measure the negative, positive, and general symptoms of schizophrenia at baseline and every 2 weeks. The Hamilton Depression Rating Scale and the Extrapyramidal Symptom Rating Scale were used to measure depression and extrapyramidal symptoms at baseline and week 8. Difference in change in negative symptoms score from the baseline to week 8 was considered the single primary outcome. At baseline, negative symptoms scores were higher than positive symptoms scores in both simvastatin and placebo groups. There was no baseline difference between the two groups in terms of any of the measured variables. Compared with the placebo group, the simvastatin group showed a significantly higher reduction in negative symptoms scores from baseline to week 8 [mean difference: 95% confidence interval=-1.42 (-2.32 to -0.52), P=0.003]. Similar findings were observed for total scores [mean difference: 95% confidence interval=-1.85 (-2.87 to -0.83), P=0.001]. The results were not significant for positive symptoms or general psychopathology scores. We found a favorable effect of simvastatin on negative symptoms of patients with schizophrenia; however, future studies are warranted to confirm these results.

RCT Entities:   Population Interventions Outcomes