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.
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.
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.
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.
From the *Maryland Psychiatric Research Center, Department of Psychiatry; and
†Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD;
‡Department of Psychiatry, Georgia Regents University, Augusta, GA;
§Spring Grove Hospital Center and Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine;
∥MS Thread, Inc, Baltimore, MD;
¶Cystic Fibrosis/Pulmonary Research and Treatment Center, University of North Carolina at Chapel Hill, Chapel Hill, NC;
#Department of Pharmacy, University of Maryland Eastern Shore School of Pharmacy, Princess Anne, MD;
**Department of Psychology and
††Mosaic Community Services, Sheppard Pratt Health System, Baltimore, MD;
‡‡Department of Psychiatry and Behavioral Sciences, George Washington University School of Medicine and Health Sciences, Washington, DC; and
§§Department of Psychiatry, Virginia Commonwealth University School of Medicine, Richmond, VA.
Received October 6, 2017; accepted after revision April 10, 2018.
Reprints: Deanna L. Kelly, PharmD, BCPP, Maryland Psychiatric Research Center, University of Maryland School of Medicine, PO Box 21247, Baltimore, MD 21228 (e-mail: email@example.com).
DAAMSEL: Dopamine Partial Agonist Aripiprazole for the Management of Symptomatic ELevated Prolactin.
This study was supported by NIMH R01MH090071-01A1 (principal investigator, D.L.K.), and aripiprazole and matching placebo were supplied by Bristol-Myers Squibb/Otsuka.
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