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Sponsors and Collaborators: |
Lindner Center of HOPE Janssen Pharmaceuticals University of Cincinnati |
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Information provided by: | Lindner Center of HOPE |
ClinicalTrials.gov Identifier: | NCT00277654 |
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).
Condition | Intervention | Phase |
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Bipolar Disorder Anxiety Disorder |
Drug: Risperidone |
Phase III |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Placebo Control, Parallel Assignment |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study of Risperidone Monotherapy in Ambulatory Bipolar Disorder With Concurrent Moderately Severe Anxiety and Lifetime Panic or Generalized Anxiety Disorder |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Subjects must not be receiving mood stabilizing, antidepressant, antipsychotic, or anxiolytic medication for
If female, subjects must be:
Exclusion Criteria:
United States, Ohio | |
University of Cincinnati Medical Center | |
Cincinnati, Ohio, United States, 45267-0559 |
Principal Investigator: | Susan L. McElroy, MD | University of Cincinnati |
Responsible Party: | Lindner Center of HOPE ( Susan L McElroy ) |
Study ID Numbers: | RIS-PAD-402 |
Study First Received: | January 12, 2006 |
Last Updated: | March 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00277654 History of Changes |
Health Authority: | United States: Institutional Review Board |
Bipolar Disorder with Concurrent Moderately Severe Anxiety and Lifetime Panic or Generalized Anxiety Disorder |
Neurotransmitter Agents Tranquilizing Agents Bipolar Disorder Risperidone Psychotropic Drugs Central Nervous System Depressants Antipsychotic Agents Serotonin |
Affective Disorders, Psychotic Dopamine Anxiety Disorders Mental Disorders Mood Disorders Dopamine Agents Psychotic Disorders |
Neurotransmitter Agents Tranquilizing Agents Disease Molecular Mechanisms of Pharmacological Action Bipolar Disorder Physiological Effects of Drugs Psychotropic Drugs Risperidone Central Nervous System Depressants Dopamine Antagonists Antipsychotic Agents |
Pharmacologic Actions Affective Disorders, Psychotic Serotonin Antagonists Pathologic Processes Serotonin Agents Anxiety Disorders Mental Disorders Therapeutic Uses Mood Disorders Dopamine Agents Central Nervous System Agents |