Sexual dysfunction, a common side effect of
antipsychotic medications, may be partly caused by
dopamine antagonism and elevation of
prolactin. In QUALIFY, a randomized study,
aripiprazole once-monthly 400 mg (AOM 400), a
dopamine D2 receptor partial agonist, showed noninferiority and subsequent superiority versus
paliperidone palmitate (PP), a
dopamine D2 receptor antagonist, on the Heinrichs-Carpenter Quality-of-Life Scale (QLS) in patients with
schizophrenia aged 18-60 years. Sexual dysfunction (Arizona Sexual Experience Scale) and serum
prolactin levels were also assessed. Odds for sexual dysfunction were lower with AOM 400 versus PP [week 28 adjusted odds ratio (95% confidence interval), 0.29 (0.14-0.61); P=0.0012] in men [0.33 (0.13-0.86); P=0.023], women [0.14 (0.03-0.62); P=0.0099], and patients aged 18-35 years [0.04 (<0.01-0.34); P=0.003]. Among patients shifting from sexual dysfunction at baseline to none at week 28, there was a trend toward greater improvement in the QLS total score. The mean (SD)
prolactin concentrations decreased with AOM 400 [-150.6 (274.4) mIU/l] and increased with PP [464.7 (867.5) mIU/l] in both men and women. Six PP-treated patients experienced
prolactin-related adverse events. In addition to greater improvement on QLS, patients had a lower risk for sexual dysfunction and
prolactin elevation with AOM 400 versus PP in QUALIFY.