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Antipsychotic treatment in women can result in hyperprolactinemia—a condition of elevated prolactin in the bloodstream that may cause irregular menstrual periods or no menstrual periods (amenorrhea), milky discharge from the breasts (galactorrhea) when not pregnant or breast-feeding, and/or painful intercourse due to vaginal dryness.
Deanna Kelly, Pharm.D., director of the Treatment Research Program at Maryland Psychiatric Research Center, and colleagues randomized 46 premenopausal women with a diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder who were stable on antipsychotics to 16 weeks of placebo or adjunctive aripiprazole (starting with 5 mg/day for the first two weeks and escalating doses to 15 mg/day if symptoms didn’t resolve). All women in the trial had elevated prolactin levels of greater than 24 ng/mL and reported menstrual dysfunction, galactorrhea, and/or sexual dysfunction related to use of an antipsychotic. At baseline, 70% of the women had at least two of these side effects.
The study participants were evaluated every two weeks for measurement of morning prolactin levels, breast exams, menstrual diary review, and a review of side effects, including sexual function.
Improvements were seen on all prolactin-related side effects for women taking adjunctive aripiprazole compared with women taking placebo. Aripiprazole was particularly effective at improving galactorrhea, with almost 80% of women having resolution of this side effect at the end of the 16 weeks compared with 33% in the placebo group.
Women also responded favorably to questions related to resumption of their menstrual periods and improvements in sexual function and libido. Women in the study indicated at exit interview that the resolution of prolactin-related symptoms would make them more inclined to continue taking their antipsychotic medication.
Psychiatric News first reported on the results of the Dopamine Partial Agonist Aripiprazole for the Management of Symptomatic Elevated Prolactin (DAAMSEL) trial after a presentation by Kelly at the 2017 meeting of the International Congress on Schizophrenia Research.
At the time, Kelly said the addition of aripiprazole to an antipsychotic regimen should be regarded as an example of “rational polypharmacy” that can help treatment adherence. “These are improvements that do really matter to women and may help with recovery-oriented treatment,” she said.
For related information, see Managing the Side Effects of Psychotropic Medications, Second Edition, from APA Publishing.
(Image: iStock/FilippoBacci)
