Risperidone Is Approved for TX of Mania in Bipolar Disorder

By Mechcatie, Elizabeth | Clinical Psychiatry News, January 2004 | Go to article overview

Risperidone Is Approved for TX of Mania in Bipolar Disorder


Mechcatie, Elizabeth, Clinical Psychiatry News


The Food and Drug Administration has approved risperidone for the short-term treatment of acute manic or mixed episodes associated with bipolar I disorder, making it one of several approvals last year for a bipolar indication.

Last month, the FDA approved risperidone (Risperdal) as monotherapy or in combination with lithium or valproate for the short-term treatment of acute manic or mixed episodes associated with bipolar I disorder. Risperidone, approved in 1994 for the treatment of schizophrenia, has been used off label for treating patients with bipolar disorder.

In June, the FDA approved the antiepileptic lamotrigine (Lamictal) for maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes, in patients treated for acute mood episodes with standard therapy. This was followed by the approval in July of olanzapine (Zyprexa) for use with lithium or valproate, for treating acute manic episodes associated with bipolar I disorder.

The recent approvals for bipolar disorder are "very exciting," considering that for many years, the only treatments available were lithium and traditional antipsychotics, said Dr. Robert Hirschfeld, professor and chair of the department of psychiatry and behavioral sciences at the University of Texas, Galveston. Risperidone "is a medication that works fast, is safe, and can be used very nicely in combination," with other drugs to treat bipolar patients, said Dr. Hirschfeld, who was not an investigator but was involved in the analysis and presentation of the results. Dr. Hirschfeld is a consultant to Janssen, marketer of risperidone; has received speaking honoraria from the company; and is also a consultant to manufacturers of other drugs used to treat bipolar disorder. …

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Risperidone Is Approved for TX of Mania in Bipolar Disorder
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