Individuals with bipolar disorder (also known as manic depression) experience significant relief of manic symptoms when treated with Risperdal (risperidone), according to research presented for the first time at a major U.S. psychiatry meeting. Bipolar disorder is a serious psychiatric illness affecting an estimated 3.4 percent 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, 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-center, double-blind Phase III study assessed 259 patients with "bipolar 1" disorder (marked by pronounced manic symptoms requiring hospitalization. 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 stabilizer. The study reported demonstrates the efficacy of Risperdal as monotherapy as well.

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.