M17. Treating Symptomatic Hyperprolactinemia in Premenopausal Women With Severe Mental Illness: Results: Of the Daamsel Clinical Trial (Dopamine Partial Agonist, Aripiprazole, for the Management of Symptomatic Elevated Prolactin)

Background: Hyperprolactinemia, a side effect of antipsychotic treatment, causes amenorrhea, oligomenorrhea, galactorrhea, gynecomastia, and sexual dysfunction. These side effects increase risk of antipsychotic nonadherence and pose significant problems in the long-term management, particularly in w...

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Published in:Schizophrenia bulletin 2017-03, Vol.43 (suppl_1), p.S217-S217
Main Authors: Kearns, Ann Marie, Kelly, Deanna, Powell, Megan, Wehring, Heidi, Hackman, Ann, Nichols, Rebecca, George, Nesley, Richardson, Charles, Vyas, Gopal, McMahon, Robert, Earl, Amber, Sullivan, Kelli, Liu, Fang, Dickerson, Faith, Feldman, Stephanie, Buchanan, Robert, Gorelick, David, Narang, Supriya, Koola, Maju, Rachbeisel, Jill, McEvoy, Joseph
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Language:English
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Summary:Background: Hyperprolactinemia, a side effect of antipsychotic treatment, causes amenorrhea, oligomenorrhea, galactorrhea, gynecomastia, and sexual dysfunction. These side effects increase risk of antipsychotic nonadherence and pose significant problems in the long-term management, particularly in women with severe mental illness. Methods: Women with antipsychotic induced hyperprolactinemia and experiencing a prolactin related side effect were recruited for a 16-week double-blind randomized placebo controlled trial of adjunct aripriprazole (5 to 15 mg day). Participants with DSM-IV schizophrenia or bipolar disorder were included. Participants were seen every 2 weeks for prolactin levels, breast exams, menstrual diary review and side effect monitoring. Other assessments were performed monthly. Results: Forty-six women were randomized to treatment ( N  = 25 aripiprazole, N  = 21 placebo). Thirty-seven completed the study ( N  = 20 (80%) aripiprazole and N =17 (81%) placebo). The mean age was 36.6 ± 9.4 years and 62% were African American. The mean baseline prolactin level was 84.3 ± 56.6, 23/37 (62%) had galactorrehea, 24/37 (65%) had oligomenorhea/ amenorrhea and 25/37 (68%) had sexual dysfunction at baseline. The prolactin level significantly decreased in the aripiprazole group compared to placebo (estimated difference −26.3 ± 12.6, df  = 35, P  = .04). Seventy-seven percent (10/13) improved or remitted on galactorrhea in the aripiprazole vs 33% (4/12) in the placebo group (Chi-Square = 4.8, df  = 1, P  = .028). Normal menstruation resumed in 46% and 27% in the aripiprazole and placebo groups, respectively ( P  = .34). With regards to sexual dysfunction, 5/20 (25%) women in the aripiprazole group had a >20% improvement in the ASEX compared to none in the placebo group ( P  = .03). Conclusion: Two-thirds of premenopausal women with severe mental illness treated with prolactin elevating medications experience galactorrhea, oligomenorrhea/amenorrhea and sexual dysfunction. Low dose aripiprazole is effective at lowering prolactin levels relative to placebo and it is particularly effective at improving galactorrhea in about 77% of women, menstruation in about 46% and sexual dysfunction in about a quarter of women. This and other accumulating data suggest that adjunct aripriprazole is a useful strategy for treating antipsychotic-induced symptomatic hyperprolactinemia in women.
ISSN:0586-7614
1745-1701
DOI:10.1093/schbul/sbx022.016