Antimanic response to aripiprazole in bipolar I disorder patients is independent of the agitation level at baseline.
OBJECTIVE
To examine the antimanic efficacy of the relatively nonsedating antipsychotic aripiprazole in patients with bipolar I disorder and high or low baseline levels of agitation.


METHODS
Data were pooled for this post hoc analysis from two 3-week, placebo-controlled trials of aripiprazole in acute mania (DSM-IV). Patients randomly assigned to aripiprazole 30 mg/day (N = 259) or placebo (N = 254) were classified as having either high (Positive and Negative Syndrome Scale [PANSS] Excited Component [PEC] score of >or=14 and a score of >or= 4 on at least one PEC item) or low (PEC < 14) levels of agitation at baseline. Efficacy measures were changes in Young Mania Rating Scale (YMRS) scores, Clinical Global Impressions-Bipolar (CGI-BP) scores, and PEC scores. Efficacy and agitation measurements were assessed by analysis of covariance.


RESULTS
From the first week of therapy onward, aripiprazole-treated subjects had significantly greater reduction from baseline in YMRS total scores than placebo-treated subjects in both the high- and low-agitation groups (p < .05 for both groups) and significantly improved CGI-BP scores vs. placebo at end point (p < .05 for both). In highly agitated patients receiving aripiprazole, PEC scores were significantly decreased versus placebo at end point (p < .05). In patients with low agitation receiving aripiprazole, no increases in PEC scores were seen, and a significant reduction in agitation symptoms was apparent after adjustment for baseline PEC scores.


CONCLUSIONS
Aripiprazole was superior to placebo in reducing the severity of both mania and agitation in highly agitated patients with bipolar I disorder and showed significant antimanic activity in patients with low levels of agitation without increasing agitation. These findings suggest that aripiprazole's antimanic effect is specific and not limited to control of agitation through sedation.
Sachs
Gary S
GS
Massachusetts General Hospital, Boston, MA 02114, USA. sachsg@aol.com
Gaulin
Bruce D
BD
Gutierrez-Esteinou
Rolando
R
McQuade
Robert D
RD
Pikalov
Andrei
A
Pultz
Joseph A
JA
Sanchez
Raymond
R
Marcus
Ronald N
RN
Crandall
David T
DT
D018692:Antimanic Agents / Q000627:therapeutic use*; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D000068180:Aripiprazole; D001714:Bipolar Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology*; D003627:Data Interpretation, Statistical; D039721:Diagnostic and Statistical Manual of Mental Disorders; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000627:therapeutic use*; D011595:Psychomotor Agitation / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology*; D015363:Quinolones / Q000627:therapeutic use*; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires
D018692:Antimanic Agents; D014150:Antipsychotic Agents; D010879:Piperazines; D015363:Quinolones; D000068180:Aripiprazole