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Risperdal Shown to Improve Manic Symptoms and Global Functioning in Many Patients With Bipolar I Disorder.

PARIS, France, June 24 /PRNewswire/ -- Many people with bipolar I disorder achieved clinically significant improvements in manic symptoms and global (social and psychological) functioning when treated with RISPERDAL(R) (risperidone), according to new information presented today at the XXIVth CINP Congress - Collegium Internationale Neuro-Pychopharmacologicum in Paris, France(1). These results are important because people with bipolar I disorder may experience extreme changes of mood, swinging from deep depression to acute mania (excessive excitement, hyperactivity and, sometimes, delusions and hallucinations), which can lead to dangerous risk-taking behaviour.

Bipolar disorder, also known as manic depressive illness, is one of the most common severe mental illnesses, affecting up to five percent of the worldwide population(2). It is the sixth leading cause of disability in developed nations worldwide(3).

A post-hoc analysis of data from two randomised, placebo-controlled, three-week trials to evaluate the treatment of bipolar mania was conducted. In both trials, significantly more risperidone-treated patients at endpoint scored higher than 50 on the Global Assessment Scale (GAS) (Note to Editors 1), a rating scale used for evaluating overall patient functioning. In one of the trials, which involved 285 patients, 78.3 percent of risperidone-treated patients scored more than 50 on the GAS, compared to only 41.5 percent of patients who received placebo(1). In addition, more than one-third (33.8 percent) of patients treated with risperidone scored over 70 on GAS. A GAS score of more than 50 indicates that the patient achieved moderate functioning; a GAS score of more than 70 indicates good functioning.

"These data show that risperidone monotherapy alleviates manic symptoms and improves psychosocial functioning," said Dr. Robert Hirschfeld, lead author and Professor and Chair of the Department of Psychiatry and Behavioral Sciences at The University of Texas Medical Branch at Galveston in the United States. "This new information will benefit many patients."

The improvements in global functioning with risperidone were maintained, as seen in a follow-up trial to the three-week studies. The results from a nine-week, open-label extension trial with 239 patients, a follow-up to these three-week studies, found that mean GAS scores improved from 56.1 to 66.8 in patients who had received placebo followed by risperidone, and from 66.9 to 77.7 in patients who had received only risperidone(4). In addition, at the end of the open-label study, more than 60 percent (62.3) of all patients who received risperidone alone achieved good functioning levels, with GAS scores higher than 70; among those who received risperidone in both the double-blind and open-label phases, 73.1 percent achieved good functioning levels, with GAS scores higher than 70(4).

Commenting on these findings, Professor Julien Mendlewicz, Professor of Psychiatry at the University of Brussels and member of the CINP coordination committee said, "The results from this study are important as they document the efficacy and patient benefits associated with risperidone as monotherapy in the treatment of acute bipolar mania."

RISPERDAL(R) is the world's most widely prescribed, new generation atypical antipsychotic. It was developed by Johnson & Johnson Pharmaceutical Research & Development and is marketed in most parts of the world by Janssen-Cilag. It is approved for a variety of conditions in more than 80 countries, including treatment of schizophrenia, behavioural and psychological disturbances in patients with dementia, acute mania associated with bipolar disorder and disruptive behaviour disorders.

The formulation of risperidone can be selected to suit the unique needs of patients; it is available in tablet form, both standard and fast-dissolving, and as an oral solution.

Notes to Editors:

1. The Global Assessment Scale (GAS) is a rating scale for evaluating the overall functioning of a patient during a specified time period on a continuum from psychological or psychiatric illness to health.

2. The tradename, regulatory status of medicines and potential indications as discussed in these materials may vary from country to country.

3. The Janssen-Cilag companies, which are members of the Johnson & Johnson (NYSE:JNJ) family of companies, one of the world's most diversified healthcare corporations, 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 CONCERTA(r) (ADHD), DUROGESIC(r) (pain management), EPREX(r) (anemia), PARIET(r) (gastroenterology), TOPAMAX(r) (epilepsy), REMINYL(r) (Alzheimer's disease), RISPERDAL(r) (schizophrenia, acute bipolar mania, behavioural psychological symptoms of dementia, disruptive behaviour disorders) and RISPERDAL(r) CONSTA(TM) (schizophrenia). More information can be found at www.psychiatry24 X 7 or at www.janssen-cilag.com

References:

1. Hirschfeld RMA, Rupnow MFT, Canuso CM. Improvements in global functioning with risperidone treatment in bipolar patients. Data presented at the CINP, Paris, France, June 2004.

2. Thomas P. The many forms of bipolar disorder: a modern look at an old illness. J Affect Disord 2004 Apr; 79 Suppl: 3-8.

3. Woods SW. The economic burden of bipolar disease. J Clin Psychiatry 2000; 61 Supp 13:38-41.

4. Rupnow MFT, Canuso CM, Janicak PG. Improvements in global functioning in bipolar patients: results from an open-label, risperidone study. Data presented at the CINP, Paris, France, June 2004.

The original language of this press release is English. Translation into other languages is provided as a courtesy by PR Newswire. Any discrepancies in the translations are the responsibility of the translator.

For further information, contact: Brigitte Byl, Johnson & Johnson, Global Pharmaceutical Communications, Europe, Middle-East, Africa, +32 (0)2-749-2772 (Belgium), Bbyl@gpcbe.jnj.com
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