title: Lovastatin as an adjuvant to lithium for treating manic phase of bipolar disorder: a 4-week, randomized, double-blind, placebo-controlled clinical trial.
abstract: Objectives. Many patients with bipolar disorder suffer from metabolic disorder. Lovastatin is effective for treating major depression. This double-blind randomized placebo controlled clinical trial investigates whether lovastatin is a useful adjuvant to lithium for treating mania. Methods. Fifty-four patients with bipolar disorder-manic phase were randomly allocated into lovastatin or placebo group. The clinical symptoms were assessed at baseline, week 2, and week 4 using Young Mania Rating Scale. Adverse effects were checked. Results. Forty-six out of 54 patients completed this trial. The mania score in the lovastatin group decreased from 40.6 (11.1) at baseline to 12.9 (8.7) and 4.1 (5.4) at weeks 2 and 4, respectively. The score in the placebo group decreased from 41.0 (11.2) at baseline to 12.8 (8.07) and 5.8 (4.6) at weeks 2 and 4, respectively. However, there was no significant difference between groups at week 2 and week 4. The adverse effects rates were comparable between the two groups. No serious adverse effect was found. Tremor and nausea were the most common adverse effects. Conclusions. Lovastatin neither exacerbated nor decreased the symptoms of mania in patients with bipolar disorder. Current results support that the combination of lovastatin with lithium is tolerated well in bipolar disorder. The trial was registered with the Iranian Clinical Trials Registry (IRCT201302203930N18).
authors.affiliation: Research Center for Psychiatry and Behavioral Sciences, Shiraz University of Medical Sciences, Shiraz, Iran ; Department of Psychiatry, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran ; Department of Neuroscience, School of Advanced Medical Sciences and Technologies, Shiraz University of Medical Sciences, Shiraz, Iran ; Shiraz University of Medical Sciences, Shiraz, Iran.
authors.forename: Ahmad
authors.identifier: 0000-0001-7397-7646
authors.initials: A
authors.lastname: Ghanizadeh
authors.affiliation: Research Center for Psychiatry and Behavioral Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.
authors.forename: Motahhar
authors.initials: M
authors.lastname: OmraniSigaroodi
authors.affiliation: Research Center for Psychiatry and Behavioral Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.
authors.forename: Ali
authors.initials: A
authors.lastname: Javadpour
authors.affiliation: Shiraz Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.
authors.forename: Mohammad Hossein
authors.initials: MH
authors.lastname: Dabbaghmanesh
authors.affiliation: Research Center for Psychiatry and Behavioral Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.
authors.forename: Sara
authors.initials: S
authors.lastname: Shafiee