Effect of bromocriptine on antipsychotic drug-induced hyperprolactinemia: eight-week randomized, single-blind, placebo-controlled, multicenter study

Abstract

Aim: The objective of the present study was to assess the efficacy and safety of bromocriptine treatment for patients with antipsychotic-drug-induced hyperprolactinemia in clinical practice.

Methods: This was an 8-week randomized, single-blind, placebo-controlled, multicenter study. Sixty female schizophrenia patients were enrolled and were randomly assigned to one of four treatment groups: bromocriptine 2.5 mg/day, 5 mg/day, 10 mg/day, and placebo. Serum levels of prolactin, estradiol (E2), luteinizing hormone (LH), and follicle-stimulating hormone (FSH) were evaluated on three occasions (baseline, and 4 and 8 weeks after commencement of the treatment paradigm). Extrapyramidal symptoms (EPS) and clinical symptoms were assessed using the Simpson-Angus scale and the Positive and Negative Syndrome Scale (PANSS), respectively.

Results: Of the 60 subjects who were enrolled, 48 completed the study (n = 14, 13, 11, and 10 in the bromocriptine 2.5 mg/day, 5 mg/day, and 10 mg/day, and placebo groups, respectively). Four patients in the 10-mg/day group, two in the 5-mg/day group, and one in the placebo group resumed menses during the study. The mean level of prolactin significantly decreased from baseline to week 4, and then plateaued, showing no significant change for the remaining 4 weeks of the study. No significant changes in LH, FSH, or E2 levels were observed throughout the 8-week study period, either within or between groups.

Conclusion: Administration of bromocriptine is a safe method for treating antipsychotic-drug-induced hyperprolactinemia without exacerbating either psychotic symptoms or EPS.