NCT00167479

A Study of Risperidone Monotherapy in Bipolar Anxiety

A Randomized, Double-Blind, Placebo-Controlled Study of Risperidone Monotherapy in Ambulatory Bipolar Disorder With Current at Least Moderately Severe Anxiety and Lifetime Panic Disorder or Generalized Anxiety Disorder

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (planned)
• Sponsor: University of South Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The specific aim of this study is to evaluate the efficacy, tolerability, and safety of risperidone monotherapy in the treatment of ambulatory bipolar disorder with comorbid lifetime panic disorder or generalized anxiety disorder and current at least moderately severe anxiety.

Detailed description

This is a randomized, double-blind, placebo controlled, parallel-group, 8-week trial of risperidone monotherapy in outpatient subjects with a lifetime bipolar I, II, or NOS disorder, a lifetime panic or generalized anxiety disorder, and current at least moderately severe anxiety symptoms. Approximately 90 subjects will be enrolled to obtain 60 subjects who complete the 8-week trial. Subjects will be randomized to risperidone or placebo in a 1:1 ratio. No concomitant psychotropic medication will be allowed except for prn lorazepam during the first two weeks for the management of affective and anxiety symptoms, and prn zolpidem and zaleplon throughout the study for the management of insomnia. Throughout the study, psychiatric scales will be used to assess psychiatric symptoms and the presence of treatment-emergent adverse events will be monitored and recorded.

Conditions

• Bipolar Disorder
• Panic Disorder
• Generalized Anxiety Disorder

Interventions

Type	Name	Description
DRUG	risperidone (Risperdal)

Timeline

• Start date: 2003-09-01
• Completion: 2006-09-01
• First posted: 2005-09-14
• Last updated: 2006-09-11

Locations

3 sites across 1 country: United States