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)

Abstract

Background: Hyperprolactinemia, a side effect of antipsychotic treatment, causes amenorrhea, oligomenorrhea, galactorrhea, gynecomastia, and sexual dysfunction. These side effects increase risk of antipsychotic non-adherence and pose signifcant 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 dis-order 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 aripip-razole, 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 oligo-menorhea/amenorrhea and 25/37 (68%) had sexual dysfunction at baseline. The prolactin level signifcantly 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, oligo-menorrhea/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 hyperprolac-tinemia in women.