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Risperdal (Risperidone) Shown to Rapidly Reduce Manic Symptoms Associated With Bipolar I Disorder

TITUSVILLE, N.J. -- June 2, 2004 -- Results from a controlled, large-scale, clinical trial show that when RISPERDAL (R) (risperidone) was used to treat patients with acute bipolar mania, a statistically significant reduction of symptoms as compared to placebo was observed as early as the third day of treatment. Moreover, patients in the three-week study receiving Risperdal achieved significantly higher rates of remission as defined by a well- validated scale measuring manic symptoms. The findings appear in the June issue of The American Journal of Psychiatry.

Bipolar I disorder is characterised by substantial swings in moods, energy and ability to function. More than two million Americans are believed to suffer from bipolar disorder, which is often under-diagnosed and under- treated.

"Bipolar disorder can be devastating. Manic behavior can cause huge problems for the patient and his or her family. The ability to control symptoms and reach remission is essential for treatment," said Robert Hirschfeld, MD, Professor and Chair, Department of Psychiatry, University of Texas Medical Branch in Galveston, Texas.

The 2-week, double-blind, placebo-controlled study evaluated 259 patients diagnosed with bipolar I disorder in an acute manic episode at multiple treatment centers throughout the United States. One hundred thirty four patients were randomised to the Risperdal monotherapy group and 125 to the placebo group. Groups were similar in terms of age, weight, gender, ethnicity and disease severity.

The primary measure of efficacy was change in score from baseline to end point on the Young Mania Rating Scale (YMRS), which clinicians use to assess the degree of a patient's manic symptoms (such as irritability, disruptive/aggressive behavior, elevated mood, increased activity, language/thought disorder and other measures) from 0 (no manic features) to 60 (maximum score).

Secondary efficacy measures included the Clinical Global Impression (CGI) severity scale and Montgomery-Asberg Depression Rating Scale (MADRS). Patients assigned to Risperdal received an average dose of 4.1mg/day. Significant reduction in overall YMRS versus placebo was seen as early as the third day of study. By the end of the study, on average, treatment with Risperdal led to a significantly greater improvement of symptoms, as shown by reduction in YMRS (reduced by 10.6 points versus 4.8 points, respectively).

Additionally, significantly more patients treated with Risperdal (43%) compared to those taking placebo (24%) showed a therapeutic response, defined as at least a 50% improvement in manic symptoms, as measured by the YMRS. Efficacy was demonstrated in patients with and without psychosis. Finally, significantly more patients taking Risperdal (38%) compared to those taking placebo (20%) achieved remission, defined as a YMRS score of 12 or less.

The Clinical Global Impression (CGI) severity scale was used to determine the severity of illness in patients. Overall, Risperdal patients saw significantly greater improvements in the severity of illness compared to those taking placebo. At the end of the study, more than twice as many

Risperdal patients (53.5%) were characterised as not ill, very mildly ill, or mildly ill compared to those taking placebo (25.8%).

Depressive symptoms were assessed using the MADRS. Risperdal was not associated with an onset or worsening of depression, a serious concern when treating bipolar disorder.

A total of 127 patients completed the study, 75 (56%) in the risperidone group and 52 (42%) in the placebo group. The most commonly reported reason for discontinuation from the study was insufficient response (36% of the placebo patients and 14% of the risperidone patients). Treatment with Risperdal was well tolerated, with a similar rate of discontinuation due to adverse events in both treatment groups (8% of Risperdal patients compared to 6% in the placebo group).

Although Risperdal patients experienced a higher rate of extrapyramidal symptoms (EPS), compared with those taking placebo, the mean increase in EPS severity scores in the Risperdal group was small but statistically significant at the end of the study (0.6 points). Adverse events occurring in more than 10% of Risperdal patients included sleepiness, headache, restlessness, dizziness, upset stomach and nausea.

In bipolar patients, the most common side effects experienced in Risperdal monotherapy studies included extrapyramidal symptoms (reversible movement disorders or muscle disturbances such as restlessness, tremors and muscle stiffness), sleepiness, dyspepsia, nausea, abnormal vision and increased saliva.

Diabetes mellitus was observed in less than or equal to 1% during the pre- marketing evaluation of Risperdal. In addition, since market introduction, hyperglycemia, diabetes mellitus aggravated, including DKA, have been reported as temporarily (but not necessarily casually) related to Risperdal therapy.


SOURCE Janssen Pharmaceutica Products, L.P.

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