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Title: Orally Disintegrating Risperidone Tablets in Patients With Major Depressive Disorder, Bipolar Disorder, or Dementia: Presented at APA

"Orally Disintegrating Risperidone Tablets in Patients With Major Depressive Disorder, Bipolar Disorder, or Dementia: Presented at APA"

By Danny Kucharsky TORONTO, CANADA -- May 23, 2006 -- Patients stable on compressed risperidone tablets were able to transition to the equivalent dose of orally disintegrating (OD) risperidone tablets with continued maintenance of effect, according to findings from an open-label study. The open-label, 4-week, multicenter trial evaluated the safety and maintenance of clinical effect in patients with major depressive disorder, bipolar disorder, or dementia who were transitioned from a regimen of compressed risperidone to OD risperidone. Results were presented here on May 23[^rd at the American Psychiatric Association Annual Meeting (APA).

OD risperidone tablets, which dissolve within 5 seconds, may provide an alternative method of drug delivery that could benefit patients with compliance and swallowing issues, said investigator Rosanna Prinzo, a toxicologist at Janssen-Ortho in Toronto, Ontario, Canada. There is a lack of previous clinical data with the orally disintegrating formulation of risperidone, she added.

The study involved 25 patients with major depressive disorder (MDD), 21 with bipolar disorder, and 20 with dementia, who had been treated with a minimum of 2 weeks of prior oral risperidone therapy with compressed tablets at a stable dose of 0.5, 1.0, or 2.0 mg/day.

Patients were evaluated using the Clinical Global Impression Severity Scale (CGI-SS) at baseline and 4 weeks after transitioning to OD risperidone.

At the final visit posttransition, 80% of MDD patients experienced no change on the CGI-SS compared with baseline (score of 0) and 16% improved by 1 point. Among those with bipolar disorder, 76% experienced no change and 19% improved by 1 point. In patients with dementia, 78% had no change and 17% improved by 1 point.

Efficacy was maintained by all patients.

Similar results were seen in measurements of anxiety, depression, and psychotic symptoms. "None of the symptoms present at baseline got worse," said Prinzo.

At the final visit, all patients gave a positive rating regarding acceptability of OD risperidone tablets on the Visual Analogue Scale. MDD patients rated their acceptability at 6.4 out of 10, bipolar disorder patients at 8.2 of 10, and dementia patients at 7.0 of 10.

No serious adverse events were reported in the MDD or bipolar disorder patient groups, but 2 cases were reported in the dementia group (1 case of atrial fibrillation and 1 case of myocardial infarction). The events were considered to be "not related" and "doubtfully related" to the use of the study drug, respectively.

Two (8%) MDD patients discontinued due to an adverse event (1 case of agitation and 1 case of dyspepsia).

Prinzo said there was no evidence of decompensation across symptom clusters measured.

The study was sponsored by Janssen-Ortho in Canada.

[Presentation title: Safety and Maintenance of Effect of Orally Disintegrating Risperidone Tablets in Patients With Major Depressive Disorder, Bipolar Disorder or Dementia, Results of an Open-label Study. Abstract NR480]

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