Journal Article

Intramuscular aripiprazole for the treatment of acute agitation in patients with schizophrenia or schizoaffective disorder: a double-blind, placebo-controlled comparison with intramuscular haloperidol

Marcus, Ronald N., Oren, Dan A., Josiassen, Richard C., Carson, William H., Manos, George, Stock, Elyse, Iwamoto, Taro, Andrezina, Raisa

2006

Overview

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. 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. 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%). These results show that IM aripiprazole is an effective treatment, comparable to IM haloperidol, and well-tolerated for acute agitation in patients with schizophrenia.

• Publisher: Springer,Springer Nature B.V
• Subject: Acute Disease / Administration, Oral / Adolescent / Adult / Adult and adolescent clinical studies / Anti-Dyskinesia Agents - administration & dosage / Anti-Dyskinesia Agents - adverse effects / Anti-Dyskinesia Agents - therapeutic use / Antipsychotic Agents - administration & dosage / Antipsychotic Agents - adverse effects / Antipsychotic Agents - therapeutic use / Aripiprazole / Basal Ganglia Diseases - chemically induced / Benzodiazepines - administration & dosage / Benzodiazepines - adverse effects / Benzodiazepines - therapeutic use / Biological and medical sciences / Blood Glucose - metabolism / Clinical trials / Comparative studies / Double-Blind Method / Drug Therapy, Combination / Female / Haloperidol - administration & dosage / Haloperidol - adverse effects / Haloperidol - therapeutic use / Humans / Injections, Intramuscular / Male / Medical sciences / Muscular system / Neuropharmacology / Pharmacology / Pharmacology. Drug treatments / Piperazines - administration & dosage / Piperazines - adverse effects / Piperazines - therapeutic use / Psycholeptics: tranquillizer, neuroleptic / Psychology. Psychoanalysis. Psychiatry / Psychomotor Agitation - complications / Psychomotor Agitation - drug therapy / Psychopathology. Psychiatry / Psychopharmacology / Psychoses / Psychotic Disorders - complications / Psychotic Disorders - drug therapy / Quinolones - administration & dosage / Quinolones - adverse effects / Quinolones - therapeutic use / Schizophrenia / Schizophrenia - complications / Schizophrenia - drug therapy / Side effects / Time Factors / Treatment Outcome / Withholding Treatment - statistics & numerical data