Clinically relevant response and remission outcomes in cariprazine-treated patients with bipolar I disorder.

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 years) 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 hoc 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.