Intramuscular aripiprazole in the control of agitation.
OBJECTIVE
To evaluate response to intramuscular (IM) aripiprazole injections using secondary analyses from clinical trials.


METHODS
Data from one trial in patients with bipolar I disorder and two trials in patients with schizophrenia were assembled and used for three secondary analyses. Analysis 1 looked at data from "nonsedated" patients (i.e., patients with scores < 8 [deep sleep] or 9 [unarousable] on the Agitation-Calmness Evaluation Scale [ACES]). In analysis 2, patients were subdivided into "higher" and "lower" agitation groups according to a median split on the baseline score for the Positive and Negative Syndrome Scale (PANSS) Excited Component (PEC) (median = 18). Analysis 3 looked at the patients who received a second injection within the 24-hour study period. In each analysis, the mean change from baseline in PEC scores was re-evaluated.


RESULTS
Analysis 1 found that nonsedated patients with bipolar I disorder and schizophrenia showed significant decreases in PEC scores following treatment with aripiprazole IM (p < 0.005). Analysis 2 found that aripiprazole IM significantly reduced agitation compared with placebo in patients with bipolar I disorder who had lower baseline agitation (p < 0.01), while patients with bipolar I disorder who had higher baseline agitation showed similarly large PEC decreases with aripiprazole (-9.9) and placebo (-7.9). Patients with schizophrenia showed significant reductions in PEC scores compared with placebo regardless of baseline level of agitation (p < 0.01). Analysis 3 found that a second injection of aripiprazole IM significantly reduced agitation in patients with bipolar I disorder or schizophrenia (p < 0.05); repeated injections were safe and well tolerated.


CONCLUSIONS
Improvements with aripiprazole IM appeared to be specific to core agitation symptoms, as opposed to nonspecific sedation, and to be independent of baseline level of agitation. Furthermore, patients benefited from a repeated aripiprazole injection when clinically warranted. These results address important clinical issues regarding use of aripiprazole IM in treating agitation.
Currier
Glenn W
GW
Department of Psychiatry, University of Rochester Medical Center, Rochester, NY 14642, USA. glenn_currier@urmc.rochester.edu
Citrome
Leslie L
LL
Zimbroff
Dan L
DL
Oren
Dan
D
Manos
George
G
McQuade
Robert
R
Pikalov
Andrei A
AA
Crandall
David T
DT
D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000068180:Aripiprazole; D001143:Arousal / Q000187:drug effects; D001714:Bipolar Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006220:Haloperidol / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage; D007273:Injections, Intramuscular; D008140:Lorazepam / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D010879:Piperazines / Q000008:administration & dosage* / Q000009:adverse effects; D011569:Psychiatric Status Rating Scales; D011595:Psychomotor Agitation / Q000188:drug therapy*; D015363:Quinolones / Q000008:administration & dosage* / Q000009:adverse effects; D016032:Randomized Controlled Trials as Topic; D012559:Schizophrenia / Q000175:diagnosis / Q000188:drug therapy*; D012565:Schizophrenic Psychology; D016896:Treatment Outcome
D014150:Antipsychotic Agents; D006993:Hypnotics and Sedatives; D010879:Piperazines; D015363:Quinolones; D000068180:Aripiprazole; D006220:Haloperidol; D008140:Lorazepam