Effects of aripiprazole once-monthly on domains of personal and social performance: results from 2 multicenter, randomized, double-blind studies.

OBJECTIVE

To assess the effects of maintenance therapy with aripiprazole once-monthly 400mg on personal and social functioning.

METHODS

Data were analyzed from 2 randomized, double-blind trials of patients with schizophrenia requiring chronic antipsychotic treatment. One study was a 52-week trial of aripiprazole once-monthly 400mg versus placebo; the other was a 38-week trial of aripiprazole once-monthly 400mg, oral aripiprazole (10-30 mg daily), and aripiprazole once-monthly 50mg (subtherapeutic dose to test assay sensitivity). Functioning was assessed using the Personal and Social Performance (PSP) scale, comprising 4 domain subscales.

RESULTS

In the 52-week study, 403 patients stabilized on aripiprazole once-monthly 400mg were randomized to receive aripiprazole once-monthly 400mg (n=269) or placebo (n=134). In the 38-week study, 662 patients stabilized on oral aripiprazole were randomized to receive aripiprazole once-monthly 400mg (n=265), oral aripiprazole (n=266), or aripiprazole once-monthly 50mg (subtherapeutic dose; n=131). In the 52-week study, mean changes from baseline were significantly worsened with placebo compared with aripiprazole once-monthly 400mg for PSP total score (P<0.001) and domain scores for Personal and Social Relationships (P<0.001), Self-Care (P<0.01), and Disturbing and Aggressive Behavior (P<0.0001). In the 38-week study, mean changes from baseline were significantly worsened with aripiprazole once-monthly 50mg compared with aripiprazole once-monthly 400mg for PSP total score (P<0.05) and the Personal and Social Relationships domain score (P<0.05).

CONCLUSION

Patient functioning, assessed using the PSP scale, was maintained in stabilized patients treated with aripiprazole once-monthly in 2 pivotal relapse studies.