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Aripiprazole Versus Placebo in the Treatment of Chronic Schizophrenia: Presented at APA
By Bruce Sylvester
PHILADELPHIA, PA -- May 23, 2002 -- The investigative drug aripiprazole provides effective and safe antipsychotic treatment in patients with chronic schizophrenia, researchers reported here this week at the annual meeting of the American Psychiatric Association (APA).
"The most important implication of this study is that it shows that aripiprazole is effective in significantly reducing the time-to-relapse as well as the rate of relapse in patients with schizophrenia who are being treated with medication," said lead investigator Teresa Pigott, MD, director of clinical trials in the department of psychiatry at the University of Florida School of Medicine in Gainesville, Florida.
The purpose of the study was to assess the time to relapse with aripiprazole, compared to placebo, over 26 weeks in stable patients with chronic schizophrenia.
The multicenter, randomized, double-blind, placebo-controlled study enrolled 310 subjects with chronic schizophrenia who were evaluated as stable, with no significant improvement or worsening in the previous three months and baseline on the Positive and Negative Symptoms for Schizophrenia (PANSS) scale of 82. They were randomized to aripiprazole 15 mg/day or placebo. Efficacy was determined by time to relapse, PANSS Total Score, and Clinical Global Improvement (CGI) score.
Significantly fewer patients in the aripiprazole group (34 percent) relapsed by study end point compared to placebo (57 percent). Aripiprazole also increased the time to relapse by two fold.
The agent was well tolerated , with an adverse events rate comparable to placebo, the researchers found. No significant changes occurred in Simpson-Angus Scale (SAS), Involuntary Movement Scale (AIMS), and Barnes Akathisia scores in either group. Weight gain in the aripiprazole group was comparable to placebo, Dr. Pigott said.
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