BY A CORRESPONDENT
ATLANTA, GEORGIA (May 25, 2005) - In two double-blind, randomized, multicenter studies reported this week at the 158thAnnual Meeting of the American Psychiatric Association, data were presented on the investigational use of intramuscular (IM) aripiprazole in patients with either acute bipolar mania or schizophrenia. The primary efficacy measure for both studies was mean change from baseline to two hours post-initial IM injection, in the Positive and Negative Syndrome Scale (PANSS) Excited Component (PEC) score: poor impulse control, tension, hostility, uncooperativeness and excitement.
In these studies, the first injection was followed by inpatient evaluation for 24 hours. If needed, a second injection was given at least two hours post-initial injection and a third injection, if needed, at least two hours post-second injection. For the placebo group, the third injection contained aripiprazole IM 10 mg.
Detailed Study Information:
Intramuscular Aripiprazole or Lorazepam versus Placebo for Agitation in Acute Mania
This double-blind, randomized, multicenter study compared two investigational doses of IM aripiprazole (10 mg and 15 mg), and IM lorazepam (2 mg) with placebo. Mean changes from baseline in PEC scores two hours after the initial IM injection were aripiprazole 10 mg (n=75), -8.7; aripiprazole 15 mg (n=75), -8.7; lorazepam 2 mg (n=68), -9.6; placebo (n=73), -5.8 (for all active drugs p-value was less than 0.001 versus placebo).
In this study, the most commonly reported adverse events for either dose of aripiprazole occurring in frequency greater than five percent were nausea, vomiting, headache, somnolence, sedation, dizziness and insomnia.
"Patients experiencing acute agitation in bipolar disorder can be highly distressed and require treatment that works quickly," said Gary Sachs, MD, Associate Professor of Psychiatry, Harvard Medical School, Director of the Bipolar Clinic and Research Program, Massachusetts General Hospital. "These data provide important information about the potential use of intramuscular medicine in this patient population."
Intramuscular Aripiprazole or Haloperidol versus Placebo in Acute Schizophrenia: A Pivotal Phase III Study
In the second double-blind, multicenter investigational trial, acutely agitated patients with schizophrenia and schizoaffective disorder were randomized to IM aripiprazole (10 mg), IM haloperidol (6.5 mg) or IM placebo in a 2:2:1 fashion. Mean changes from baseline in PEC scores two hours post-initial IM injection were aripiprazole (n=173), -7.3; haloperidol (n=184), -7.8; and placebo (n=88), -4.8 (p-value less than 0.001 for both drugs versus placebo).
The most commonly reported adverse events for aripiprazole in this study, occurring in frequency greater than or equal to five percent were headache, dizziness, nausea and insomnia.
Aripiprazole is indicated for the treatment of schizophrenia including maintaining stability in patients who had been symptomatically stable on other antipsychotic medications for periods of three months or longer and observed for relapse during a period of up to 26 weeks. Aripiprazole is also indicated for the treatment of acute manic and mixed episodes associated with Bipolar I Disorder. Most recently, in March 2005, aripiprazole was FDA-approved for maintaining efficacy in patients with Bipolar I Disorder with a recent manic or mixed episode who had been stabilized and then maintained for at least six weeks. Physicians who elect to use aripiprazole for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. Since its initial approval in 2002, over 3.7 million prescriptions have been written in the United States. i
Aripiprazole is available by prescription only. In addition to administration as a once-daily tablet, aripiprazole was recently FDA-approved in a 1 mg/mL oral solution. Aripiprazole Oral Solution is an important new treatment option for adult patients who are unable to or have difficulty swallowing tablets, and provides flexibility in addressing individual patient needs. Patients should talk to their healthcare provider for more information. To learn more about aripiprazole and for full product information, please visit
BY A CORRESPONDENT