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Adjunct Aripiprazole Reduces Prolactin and Prolactin-Related Adverse Effects in Premenopausal Women With Psychosis

Results From the DAAMSEL Clinical Trial

Kelly, Deanna L., PharmD, BCPP*; Powell, Megan M., BA; Wehring, Heidi J., PharmD, BCPP; Sayer, MacKenzie A., BS; Kearns, Ann Marie, MS; Hackman, Ann L., MD; Buchanan, Robert W., MD; Nichols, Rebecca B., BS; Adams, Heather A., PsyD§; Richardson, Charles M., MD§; Vyas, Gopal, DO§; McMahon, Robert P., PhD; Earl, Amber K., MA; Sullivan, Kelli M., MPH; Liu, Fang, MS; Luttrell, Sarah E., PharmD, BCPS#; Dickerson, Faith B., PhD, MPH**; Feldman, Stephanie M., MSW; Narang, Supriya, MD††; Koola, Maju M., MD‡‡; Buckley, Peter F., MD§§; RachBeisel, Jill A., MD; McEvoy, Joseph P., MD

Journal of Clinical Psychopharmacology: August 2018 - Volume 38 - Issue 4 - p 317–326
doi: 10.1097/JCP.0000000000000898
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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.

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: dkelly@mprc.umaryland.edu).

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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