Study results published in the Journal of Clinical Psychopharmacology support the efficacy of adjunctive aripiprazole in reducing prolactin-related adverse effects in premenopausal women with psychosis.
The Dopamine partial Agonist Aripiprazole for the Management of Symptoms of ELevated prolactin (DAAMSEL) study was a randomized, double-blind, placebo-controlled, 16-week trial designed to assess the efficacy and tolerability of adjunctive aripiprazole in treating symptomatic hyperprolactinemia in premenopausal women. Study participants had a diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder and were currently experiencing hormonal adverse effects on a prolactin-elevating antipsychotic. A total of 46 women were randomly assigned (n=25 aripiprazole; n=21 placebo) to study arms and were assessed biweekly for prolactin elevation and galactorrhea. Psychiatric symptoms and adverse effects were closely monitored, and each patient completed a menstrual diary review. All patients had elevated prolactin (>24 ng/mL) levels at baseline.
Of 46 participants, 37 completed at least 8 weeks of the study (80% aripiprazole; 81% placebo). Aripiprazole (mean dose, 11.7±2.4 mg/d) was effective in lowering prolactin relative to placebo (P =.04). By the end of the trial, 45% of the aripiprazole group had a normalized prolactin level (<24 mg/mL) compared with just 12% of the placebo group (P =.028). Galactorrhea resolved in 77% of the aripiprazole group vs 33% of the placebo group (P =.028). Additionally, normalization of sexual function was reported by 50% of aripiprazole-treated patients compared with just 9% of placebo-treated patients (P =.030). No significant between-group differences were observed for psychiatric symptoms or adverse effects. Women treated with aripiprazole reported satisfaction, in particular, with improvement in sexual function.
These data suggest that aripiprazole can be safely used in premenopausal women to treat elevated prolactin levels and prolactin-related adverse effects. Although longer-term studies are needed to further assess the risks and benefits of long-time use, these data may be helpful to clinicians in treating women experiencing adverse effects on a prolactin-elevating antipsychotic.
Disclosures: RB has served on the advisory boards of Astellas Pharma, Inc.; Boehringer Ingelheim-RCV GmbH & Co KG; Instrument Technology, Inc.; and Lundbeck, Inc.; he has also been a consultant for Takeda Pharmaceuticals North America, Inc.; Upsher-Smith Laboratories, Inc., and been on the Data Safety and Monitoring Board for Pfizer Inc. JPM received honoraria for advisory boards with Neurocrine Biosciences, Inc. and Teva Pharmaceuticals USA during the past 2 years. DLK served on the advisory board for Lundbeck, Inc. and a consultant for HLS Therapeutics Inc. The other authors declare no conflicts of interest.
Kelly DL, Powell MM, Wehring HJ. Adjunct aripiprazole reduces prolactin and prolactin-related adverse effects in premenopausal women with psychosis: results from the DAAMSEL clinical trial. J Clin Psychopharmacol. 2018 Aug;38(4):317-326.