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.
Masand
Prakash S
PS
Duke University Medical Center, Durham, NC, USA. pmasand2001@yahoo.com
Eudicone
James
J
Pikalov
Andrei
A
McQuade
Robert D
RD
Marcus
Ronald N
RN
Vester-Blokland
Estelle
E
Carlson
Berit X
BX
D000328:Adult; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D000068180:Aripiprazole; D001714:Bipolar Disorder / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D010879:Piperazines / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales; D015363:Quinolones / Q000627:therapeutic use*; D012008:Recurrence
D014150:Antipsychotic Agents; D010879:Piperazines; D015363:Quinolones; D000068180:Aripiprazole