TITUSVILLE, N.J., Dec. 11 -- PRNewswire/AsiaNet
Individuals with bipolar disorder (also known as manic depression) experience significant relief of manic symptoms when treated with RISPERDAL(R) (risperidone), according to research presented for the first time today at a major U.S. psychiatry meeting*. Bipolar disorder is a serious psychiatric illness affecting an estimated 3.4% of the population, in which patients can experience dramatic mood swings from deep depression to acute mania (with symptoms such as an excessively "high" mood, racing thoughts, poor concentration and unrealistic beliefs about one's own abilities and powers).
"Within three days of initiating monotherapy treatment with risperidone, patients showed significant improvement in symptom control," said lead investigator Robert Hirschfield, MD, professor and chair of the Department of Psychiatry at the University of Texas Medical Branch in Galveston, USA."Manic symptoms can lead to devastating consequences such as squandering family savings, break-up of marriages and even physically dangerous behaviours."
The multi-centre, double-blind Phase III study assessed 259 patients with "bipolar 1" disorder (marked by pronounced manic symptoms requiring hospitalisation. These individuals were randomly assigned to receive 1-6 mg of Risperdal daily (average dose was 4.1 mg) or placebo for three weeks. Patients' symptoms were assessed at the beginning of the research using the YMRS (Young Mania Rating Scale, a widely accepted measurement of manic symptoms) and the primary efficacy was the average change in the YMRS score by the end of the study.
Patients taking Risperdal in the study experienced improvements in their YMRS scores that were significantly greater than those for individuals who received placebo (a drop of 11.1 points for Risperdal versus a decrease of 5 for placebo). Significant improvements were observed with Risperdal as early as day three and were sustained throughout the trial. In addition, significant symptom relief was shown using another assessment tool, the Clinicians' Global Impression-Severity scale. Physicians using this device reported that individuals receiving Risperdal improved twice as much as patients who took placebo.
More Risperdal-treated patients completed the study than those who took placebo. The most frequently reported side effects were drowsiness, dizziness, nausea, dyspepsia (upset stomach), weight gain and excessive fidgeting in Risperdal-treated patients, compared to headache in the placebo group.
The study was conducted by Johnson & Johnson Pharmaceutical Research and Development (J&JPRD). Marketed in most countries by Janssen-Cilag, Risperdal is approved in more than 80 countries for the treatment of schizophrenia and other conditions and in 13 countries** to date for the treatment of mania associated with bipolar disorder, when added on to a mood stabiliser. The study reported today demonstrates the efficacy of Risperdal as monotherapy as well.
Today, Risperdal has earned the status of the world's most widely prescribed atypical antipsychotic. In addition to traditional tablets in various strengths, risperidone is available in oral solution and -- in a growing number of countries -- as a long-acting injection called Risperdal Consta(TM).
* The organisation does not permit in press releases the
use of its name or the cities in which it meets.
** Austria, Iceland, Ireland, Portugal, Spain, Switzerland,
Czech Republic, Hungary, Russia, Turkey, Korea, Mexico,
Philippines.
The Janssen-Cilag companies are affiliates of Johnson & Johnson, the world's most diversified healthcare corporation. The companies have a long track record in developing and marketing treatments for central nervous system disorders, pain management, fungal infections and gastrointestinal conditions. Leading products include Eprex(R) (epoetin alfa), Risperdal(R) (risperidone), Sporanox(R) (itraconazole), Durogesic(R) (transdermal fentanyl), Topamax(R) (topiramate), Pariet(R) (rabeprazole sodium) and Reminyl(R) (galantamine). More information can be found at www.psychiatry24x7.com or www.janssen-cilag.com
SOURCE: Janssen-Cilag
CONTACT: Pam Rasmussen of Janssen-Pharmaceutica
+1-609-730-2986
Web site: http://www.psychiatry24x7.com
http://www.janssen-cilag.com
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--Distributed by AsiaNet (www.asianetnews.net)--
