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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
University of South Florida Psychiatry Center
Tampa, Florida, United States
University of Cincinatti
Cincinnati, Ohio, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Clinician Global Improvement Scale (CGI-21)
Sheehan Panic Disorder Scale (SPS)
The Psychic and Somatic factors of the HAM-A
Young Mania Rating Scale, Total Score
Inventory of Depressive Symptoms, Total Score
Patient Global Improvement Scale (PGI-21)
The Clinician Global Improvement-Bipolar (CGI-BP)
The Family Impact Scale (FIS)
The Sheehan Disability Scale - Total Disability Score, Work Disability Score, Social Disability Score, Family Disability Score
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