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.