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| |  APA: Aripiprazole for Long-Term Maintenance Treatment in Schizophrenia By Bruce Sylvester PHILADELPHIA, PA -- May 23, 2002 -- The investigative antipsychotic drug aripiprazole produced improvements in positive, negative and depressive symptoms of schizophrenia during a 52-week study, researchers reported at the annual meeting of the American Psychiatric Association (APA). "Beyond the short-term clinical trials that have demonstrated acute efficacy, this study looks at aripiprazole in more long-term or maintenance treatment for schizophrenia. This is a chronic disorder with frequent relapses. In this study we looked at patients having acute relapses of their illness, at their stabilization with aripiprazole and then maintenance of the efficacy of the effect of this treatment over a one-year period," said Mary J. Kujawa, MD, medical director of US neuroscience medical affairs at Bristol-Myers Squibb Company in Princeton, New Jersey. The mechanism of action of aripiprazole appears to be different from other available antipsychotics. Aripiprazole shows potent partial agonism of D2 dopamine receptors, partial agonism of 5HT1A serotonin receptors and antagonism of 5HT2A serotonin receptors. Partial agonism means that aripiprazole blocks the receptor if it is overstimulated and stimulates it if it when activity is needed. The investigators in this multicenter, randomized, double-blind study recruited 1,294 subjects suffering an acute relapse of chronic schizophrenia. They randomized 861subjects to aripiprazole 30 mg/day and 433 to haloperidol 10 mg/day. They allowed a one-time dose reduction to aripiprazole 20 mg/day and haloperidol 7 mg/day. The investigators used Positive and Negative Symptoms for Schizophrenia (PANSS) and the Montgomery-Asberg Depression Rating Scale (MADRS) scores to evaluate efficacy throughout the study. Compared to the haloperidol cohort, a much larger percentage of patients treated with aripiprazole showed a therapeutic response and remained in treatment at weeks 8, 26, and 52 (week 52: 40 percent vs. 27 percent, p<0.001). Compared to haloperidol, aripiprazole elicited statistically significant improvements in the PANSS negative subscale and in depressive symptoms as shown in the MADRS. Extrapyramidal effect-related adverse events were significantly lower with aripiprazole than with haloperidol (p<0.001). Weight gain was comparable in both groups of subjects. QTc interval were also comparable between the groups. "One of the most difficult challenges in treating patients with schizophrenia is long-term adherence," said Jeffrey Lieberman, MD, professor of psychiatry and pharmacology at the University of North Carolina Medical School in Chapel Hill. "Data from this study suggests the potential for significant benefits of aripiprazole in the long-term treatment of schizophrenia, a chronic mental illness that affects approximately 1 percent of the world’s population."
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