Intramuscular aripiprazole for the treatment of acute agitation in patients with schizophrenia or schizoaffective disorder: a double-blind, placebo-controlled comparison with intramuscular haloperidol.
BACKGROUND
This double-blind, placebo-controlled study investigated the efficacy and safety of intramuscular (IM) aripiprazole and IM haloperidol for the treatment of acute agitation in patients with schizophrenia or schizoaffective disorder.


METHODS
Four-hundred and forty-eight patients were randomized (2:2:1 ratio) to IM aripiprazole 9.75 mg, IM haloperidol 6.5 mg, or IM placebo. Patients could receive up to three injections over the first 24 h, with second and third injections administered > or =2 and > or =4 h, respectively, after the first if deemed clinically necessary. Primary efficacy measure was mean change in Positive and Negative Syndrome Scale Excited Component (PEC) score from baseline to 2 h.


RESULTS
Mean improvement in PEC at 2 h was significantly greater for IM aripiprazole (-7.27) vs placebo (-4.78; p<0.001); IM aripiprazole was noninferior to IM haloperidol (-7.75) on PEC. All secondary efficacy measures showed significantly greater improvements at 2 h for IM aripiprazole and IM haloperidol over placebo. Mean number of injections/patient and percentage of patients requiring benzodiazepines were significantly lower for IM aripiprazole vs placebo (p<0.01). IM aripiprazole was well tolerated. Extrapyramidal symptom-related adverse events were similar for aripiprazole (1.7%) and placebo (2.3%) and lower than with haloperidol (12.6%).


CONCLUSIONS
These results show that IM aripiprazole is an effective treatment, comparable to IM haloperidol, and well-tolerated for acute agitation in patients with schizophrenia.
Andrezina
Raisa
R
Department of Psychiatry, Riga Mental Health Care Centre, Tvaika Street 2, Riga, 1005, Latvia.
Josiassen
Richard C
RC
Marcus
Ronald N
RN
Oren
Dan A
DA
Manos
George
G
Stock
Elyse
E
Carson
William H
WH
Iwamoto
Taro
T
D000208:Acute Disease; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D018726:Anti-Dyskinesia Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000068180:Aripiprazole; D001480:Basal Ganglia Diseases / Q000139:chemically induced; D001569:Benzodiazepines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D001786:Blood Glucose / Q000378:metabolism; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006220:Haloperidol / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D010879:Piperazines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011595:Psychomotor Agitation / Q000150:complications / Q000188:drug therapy*; D011618:Psychotic Disorders / Q000150:complications / Q000188:drug therapy*; D015363:Quinolones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012559:Schizophrenia / Q000150:complications / Q000188:drug therapy*; D013997:Time Factors; D016896:Treatment Outcome; D028761:Withholding Treatment / Q000706:statistics & numerical data
D018726:Anti-Dyskinesia Agents; D014150:Antipsychotic Agents; D001786:Blood Glucose; D010879:Piperazines; D015363:Quinolones; D001569:Benzodiazepines; D000068180:Aripiprazole; D006220:Haloperidol