A new study evaluated the efficacy and safety of a new psychotropic agent for the treatment of schizophrenia in a 6-week, randomized, placebo-controlled trial.
Although the trial was brief, and the sample size relatively small, the mechanism by which the active metabolite of the drug risperidone is delivered may provide physicians another treatment option.
Schizophrenia is one of the most debilitating of the major psychiatric disorders, and is also one of the most difficult to treat. Although numerous antipsychotic treatments are available, they can cause significant side effects and many patients experience only a partial relief of their symptoms and up to 30 percent no relief at all.
In the study scheduled for publication in the December 15th issue of Biological Psychiatry, Marder and colleagues examined the efficacy and safety of a new psychotropic agent for the treatment of schizophrenia.
The authors studied paliperidone extended-release (ER) tablets, an investigational drug which orally delivers the active metabolite of the drug risperidone, which is an already established efficacious antipsychotic.
The authors recruited 444 patients who were experiencing an acute episode of schizophrenia and, after evaluating the severity of their symptoms, administered one of four treatments for 6 weeks: 6 mg or 12 mg/day of paliperidone ER, 10 mg/day of olanzapine (the active comparator), or placebo. During the six weeks of treatment, the investigators monitored the patients for side effects and assessed their symptom improvement.
Dr. Stephen Marder, senior author on the paper, explains the findings: “This double-blind study found that two doses of paliperidone extended release tablets were more effective than placebo for treating the symptoms of acute schizophrenia. Patients receiving the most effective dose of paliperidone (6 mg) also demonstrated improvements in their social functioning.”
Jeffrey A. Lieberman, M.D., Chairman of the Department of Psychiatry at Columbia University and Director of the New York State Psychiatric Institute, comments, “This study demonstrates the efficacy of the 9-hydroxy metabolite of risperidone that has antipsychotic efficacy and an acceptable safety profile which provides psychiatrists with yet another treatment option. It has practical advantages with its long half life, duration of action and extended release formulation.”
Dr. Lieberman cautions though that this finding is not “a novel or breakthrough treatment and does not provide major differences or advantages over existing treatments.” Additional studies are currently underway to further evaluate the long-term (up to one year) efficacy and safety of paliperidone ER in the treatment of schizophrenia.