Criteria for defining symptomatic and sustained remission in bipolar I disorder: a post-hoc analysis of a 26-week aripiprazole study (study CN138-010).

OBJECTIVE

Remission is a key goal after treating an acute episode of bipolar I disorder, but greater understanding is needed of the correlation between attaining remission at a specific time point and maintaining sustained remission. This post-hoc analysis assessed symptomatic point remission and sustained remission according to either a standard criterion (YMRS ≤ 12) or a set of more rigorous criteria (YMRS ≤ 7, MADRS ≤ 10, and CGI-I = 1) using data from a 26-week, randomized, double-blind, placebocontrolled study with the atypical antipsychotic aripiprazole in patients with bipolar I disorder.

METHODS

Following ≥ 6 consecutive weeks' stabilization with open-label aripiprazole, 161 patients were randomized (1:1) to aripiprazole or placebo for up to 26 weeks. Symptomatic remission rates were determined at Weeks 8, 16, and 26; sustained remission rates were determined at each visit up until Weeks 8, 16, and 26, including a requirement to maintain remission for ≥ 8 consecutive weeks (frequency counts, LOCF analysis).

RESULTS

Compared with the standard criterion (YMRS ≤ 12), symptomatic and sustained remission criteria were fulfilled at a lower rate at all time points when defined with YMRS ≤ 7, and lower still with additional MADRS ≤ 10 and CGI-I = 1 criteria. In aripiprazole-treated patients, symptomatic remission rates were consistent at Weeks 8, 16, and 26; sustained remission rates at Week 8 were retained at Weeks 16 and 26.

CONCLUSIONS

When discerning an operational definition of remission in patients with a recent manic or mixed episode, the YMRS ≤ 7 criterion and sustaining this criterion for ≥ 8 weeks can be a useful clinical or research tool for assessing clinical recovery.