Adjunct Aripiprazole Reduces Prolactin and Prolactin-Related Adverse Effects in Premenopausal Women With Psychosis: Results From the DAAMSEL Clinical Trial. Issue 4 (August 2018)

• Record Type: Journal Article
• Authors: Kelly, Deanna L.; Powell, Megan M.; Wehring, Heidi J.; Sayer, MacKenzie A.; Kearns, Ann Marie; Hackman, Ann L.; Buchanan, Robert W.; Nichols, Rebecca B.; Adams, Heather A.; Richardson, Charles M.; Vyas, Gopal; McMahon, Robert P.; Earl, Amber K.; Sullivan, Kelli M.; Liu, Fang; Luttrell, Sarah E.; Dickerson, Faith B.; Feldman, Stephanie M.; Narang, Supriya; Koola, Maju M.; Buckley, Peter F.; RachBeisel, Jill A.; McEvoy, Joseph P.
• Is Part Of: Journal of clinical psychopharmacology. Volume 38:Issue 4(2018)
• Publication Date: 2018-08
• Subjects: aripiprazole -- clinical trial -- prolactin -- sexual dysfunction -- women; Psychopharmacology -- Periodicals; Psychopharmacology -- Periodicals; Psychopharmacologie -- Périodiques; Psychopharmacology; Periodicals; 615.78
• DOI: 10.1097/JCP.0000000000000898
• Languages: English
• ISSNs: 0271-0749

Abstract

Abstract: Purpose/Background: Prolactin-related adverse effects contribute to nonadherence and adverse health consequences, particularly in women with severe mental illness. Treating these adverse effects may improve treatment acceptability, adherence, and long-term outcomes. Methods/Procedures: Premenopausal women with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder were recruited for a randomized, double-blind, placebo-controlled 16-week trial of adjunct aripiprazole (5–15 mg/d). Participants had elevated prolactin (>24 ng/mL) and were experiencing galactorrhea, amenorrhea, oligomenorrhea, or sexual dysfunction on a prolactin-elevating antipsychotic. Participants were evaluated biweekly for prolactin elevation and galactorrhea and completed a menstrual diary review. Psychiatric symptoms and adverse effects were closely monitored. Findings/Results: Forty-six women were randomized (n = 25 aripiprazole, n = 21 placebo). Thirty-seven completed at least 8 weeks of the study (n = 20 [80%] aripiprazole and n = 17 [81%] placebo). Aripiprazole (mean dose, 11.7 ± 2.4 mg/d) was effective for lowering prolactin relative to placebo ( P = 0.04). In addition, 45% (9/20) of the aripiprazole group had a normalized prolactin (<24 mg/mL) compared with 12% (2/17) of the placebo group ( P = 0.028). Galactorrhea resolved in 77% (10/13) of the aripiprazole-treated participants compared with 33% (4/12) in the placebo group ( P = 0.028). Normalization of sexual function (<16 on the Arizona Sexual Experience Scale) occurred in 50% on aripiprazole (7/14) versus 9% (1/11) on placebo ( P = 0.030). No differences between groups in symptoms or adverse effects were noted. Overall, women rated a mean score of 4.6 ± 0.6 on a 5-point Likert scale for sexual function improvement, suggesting their particular satisfaction with improvement in this domain. Implications/Conclusions: Building upon prior studies, this rigorous evaluation confirms the utility of adjunctive aripiprazole as a strategy for improving prolactin and managing prolactin-related adverse effects in premenopausal women with psychosis. Abstract : Supplemental digital content is available in the text.