103. Adjunctive Aripiprazole Treatment for Psychiatric Symptoms in Premenopausal Women: Results: From the Daamsel Clinical Trial

Abstract Women have been largely underrepresented in clinical trials in schizophrenia yet have a different presentation of symptoms, such as higher affective symptoms compared to men. Thus, adjunctive antipsychotic treatment, particularly low-dose aripiprazole, in women may be an effective strategy, particularly for its effects on anxious or depressive symptoms. Premenopausal women with schizophrenia or bipolar disorder were recruited for a randomized double-blind, 16-week trial of adjunct aripriprazole (5 to 15 mg day). The primary study population was those with symptomatic hyperprolactinemia (these results reported elsewhere). Stable participants were evaluated biweekly for psychiatric symptoms using the Brief Psychiatric Rating Scale (BPRS), the Scale for the Assessment of Negative Symptoms (SANS), the Calgary Depression Rating Scale (CDS), and the Clinical Global Improvement (CGI). The Psychological General Well Being Index (PGWB) and the Repeatable Battery for Assessment of Neurological Symptoms (RBANS) were performed monthly and end of study, respectively. Forty-four women were randomized and received medication (N = 24 aripiprazole and N = 20 placebo). Four aripiprazole participants discontinued (2 clinical worsening, 1 patient choice, and 1 nonadherence) and 3 discontinued in the placebo group (patient choice, medication nonadherence and administrative pharmacy error). There were no significant treatment differences in BPRS, SANS, CDS, or CGI scores between the aripiprazole and placebo groups ( > .05). Robust response on the total BPRS (>30% response) was noted in (12%) in the aripiprazole group vs. none in the placebo group ( = .12). There were no differences in RBANS or PGWB index scores and no differences in side effects noted. This clinical trial suggests that adjunct treatment aripiprazole to treat symptomatic hyperprolactinemia in clinically stable women does not significantly improve psychiatric symptoms in most patients. However, 12% of women had robust symptom improvements (>30%) in BPRS scores, and 10% had worsening of BPRS scores leading to discontinuation. No significant improvements were noted in any other clinical ratings such as anxiety, depression or cognition. Nonetheless, adjunct aripriprazole is a safe strategy for stable patients when added for symptomatic hyperprolatinemia, and future work should help distinguish which factors may predict robust symptoms improvements and which women may have clinical worsening that occur in about 10%–12% of patients using this strategy.