Study of Risperidone Monotherapy in Ambulatory Bipolar Disorder With Concurrent Moderately Severe Anxiety and Lifetime Panic or Generalized Anxiety Disorder

Summary

The purpose of this research study is to evaluate the safety, tolerability, and efficacy (how well the drug works) of risperidone compared to placebo (an inactive drug) in the treatment of bipolar disorder with panic disorder or generalized anxiety disorder. Risperidone is currently approved by the United States Food and Drug Administration (FDA) for the treatment of schizophrenia and bipolar mania. Risperidone is not currently FDA approved for the treatment of bipolar hypomania with or without panic disorder or generalized anxiety disorder (the condition being investigated in this study).

Timeline

Start

2004-02

Primary completion

2009-03

Completion

2009-03

Publications

• Results Sheehan DV, McElroy SL, Harnett-Sheehan K, Keck PE Jr, Janavs J, Rogers J, Gonzalez R, Shivakumar G, Suppes T. Randomized, placebo-controlled trial of risperidone for acute treatment of bipolar anxiety. J Affect Disord. 2009 Jun;115(3):376-85. doi: 10.1016/j.jad.2008.10.005. Epub 2008 Nov 29.

Drugs

Indications