Clinically relevant response and remission outcomes in cariprazine-treated patients with bipolar I disorder (original) (raw)

Background: Rates of response and remission are measures that endorse the clinical significance of treatment. Cariprazine is FDA-approved for the acute treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder in adults. Post hoc analyses of pooled data from 3 pivotal trials of cariprazine in manic/mixed episodes associated with bipolar I disorder were conducted to investigate the effect of cariprazine on various criteria of response and remission. Methods: The constituent studies were 3-week randomized, double-blind, placebo-controlled, multicenter, parallel-group phase II/III studies in adult patients (age, 18-65) with bipolar I disorder (NCT00488618, NCT01058096, NCT01058668). Post hoc analyses included Young Mania Rating Scale (YMRS) outcomes for response (≥50% decrease in score), remission (total score ≤12 and ≤8), cumulative remission, and global improvement. Additionally, composite remission (YMRS total score ≤12 plus Montgomery-Åsberg Depression Rating Scale total score ≤12) and worsening/switch to depression (MADRS total score ≥15) by week were investigated. Results: Rates of response and remission were significantly greater for cariprazine versus placebo on every measure evaluated (P<.01 all analyses); the estimated number needed to treat for each measure was ≤10. There was no evidence of worsening/switch to depression. Limitations: Post analyses, short treatment duration, no active comparator. Discussion: Cariprazine-treated patients with bipolar I disorder attained clinically significant improvement in manic symptoms as shown by significantly greater rates of response and remission versus placebo; improvement in manic symptoms did not induce depressive symptoms.