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Sponsors and Collaborators: |
University of South Florida Janssen, LP |
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Information provided by: | University of South Florida |
ClinicalTrials.gov Identifier: | NCT00167479 |
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.
Condition | Intervention | Phase |
---|---|---|
Bipolar Disorder Panic Disorder Generalized Anxiety Disorder |
Drug: risperidone (Risperdal) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 60 |
Study Start Date: | September 2003 |
Estimated Study Completion Date: | September 2006 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
University of South Florida Psychiatry Center | |
Tampa, Florida, United States, 33613-4788 | |
United States, Ohio | |
University of Cincinatti | |
Cincinatti, Ohio, United States | |
United States, Texas | |
University of Texas Southwestern Medical Center | |
Dallas, Texas, United States |
Principal Investigator: | David V. Sheehan, MD, MBA | University of South Florida College of Medicine |
Principal Investigator: | Susan L. McElroy, MD | University of Cincinatti, Department of Psychiatry |
Principal Investigator: | Trisha - Suppes, MD, PhD | University of Texas Southwestern Medical Center |
Principal Investigator: | Paul E. Keck, MD | University of Cincinatti, Department of Psychiatry |
Study ID Numbers: | 101541d, RIS-BIP-408 |
Study First Received: | September 10, 2005 |
Last Updated: | September 8, 2006 |
ClinicalTrials.gov Identifier: | NCT00167479 |
Health Authority: | United States: Institutional Review Board |
Bipolar Anxiety Bipolar Disorder Anxiety Panic Disorder Generalized Anxiety Disorder |
GAD Risperidone Double-Blind Placebo Controlled |
Affective Disorders, Psychotic Panic Disorder Dopamine Anxiety Disorders Mental Disorders |
Bipolar Disorder Risperidone Mood Disorders Psychotic Disorders Serotonin |
Neurotransmitter Agents Disease Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Dopamine Antagonists |
Antipsychotic Agents Pharmacologic Actions Serotonin Antagonists Pathologic Processes Serotonin Agents Therapeutic Uses Dopamine Agents Central Nervous System Agents |