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

This study has been completed.
Sponsor:
Collaborators:
Janssen Pharmaceuticals
University of Cincinnati
Information provided by (Responsible Party):
Lindner Center of HOPE
ClinicalTrials.gov Identifier:
NCT00277654
First received: January 12, 2006
Last updated: December 12, 2011
Last verified: December 2011
  Purpose

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
Bipolar Disorder
Anxiety Disorder
Drug: Risperidone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Lindner Center of HOPE:

Primary Outcome Measures:
  • Clinical Global Improvement-21 Anxiety scale (CGI-21 Anxiety) [ Time Frame: weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hamilton Anxiety scale (HAM-A) [ Time Frame: weekly ] [ Designated as safety issue: No ]

Enrollment: 111
Study Start Date: February 2004
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Risperidone Drug: Risperidone
risperidone 0.5mg up to 4mg daily vs. placebo
Other Name: Risperidal
Placebo Comparator: Sugar pill Drug: Risperidone
risperidone 0.5mg up to 4mg daily vs. placebo
Other Name: Risperidal

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects must be 18 years of age or older.
  2. Subjects must have lifetime bipolar I, II, or NOS disorder as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria.
  3. Subjects must have lifetime panic disorder or generalized anxiety disorder (GAD) as defined by DSM-IV criteria (except clause "does not occur exclusively during a mood disorder" of Criterion F for GAD) .
  4. Subjects' bipolar symptoms must be no more than moderately severe, defined as a CGI-BP < 4.
  5. Subjects' anxiety symptoms must be at least moderately severe, defined as a CGI-S > 4.
  6. Subjects must not be receiving mood stabilizing, antidepressant, antipsychotic, or anxiolytic medication for > one week prior to baseline. Patients receiving fluoxetine or depot antipsychotics should be off these medications for > four weeks prior to baseline.
  7. Subjects or their legally authorized representative must sign the Informed Consent Document after the nature of the trial has been fully explained.
  8. If female, subjects must be:

    • postmenopausal,
    • surgically incapable of childbearing,
    • or practicing medically acceptable effective method(s) of contraception (e.g., hormonal methods, barrier methods, intrauterine device) for at least one month prior to study entry and throughout the study.

Exclusion Criteria:

  1. Subjects who do not have lifetime bipolar disorder by DSM-IV-TR (text revision) criteria.
  2. Subjects who do not have lifetime panic disorder or generalized anxiety disorder by DSM-IV-TR criteria.
  3. Subjects who are receiving treatment with an antimanic or mood stabilizing medication (lithium, valproate, carbamazepine, or an antipsychotic), and in the investigators' judgment, require ongoing treatment with that medication.
  4. Subjects whose bipolar symptoms are presently more than moderately severe (CGI-BP > 5).
  5. Subjects whose anxiety symptoms are presently less than moderately severe (CGI < 3).
  6. Subjects with clinically significant suicidal or homicidal ideation.
  7. Subjects with current psychotic symptoms.
  8. Subjects with a current DSM-IV Axis I diagnosis of delirium, dementia, amnesia, or other cognitive disorders; a DSM-IV diagnosis of a substance dependence disorder within the past six months; or a lifetime DSM-IV psychotic disorder (e.g., schizophrenia or schizoaffective disorder).
  9. Subjects with serious general medical illnesses including hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, or hematologic disease as determined by the clinical judgment of the clinical investigator. Subjects with hypo- or hyperthyroidism unless stabilized on thyroid replacement > 3 months.
  10. Subjects with a clinically significant abnormality in their prestudy physical exam, vital signs, EKG, or laboratory tests.
  11. Subjects who are allergic to or who have demonstrated hypersensitivity to risperidone.
  12. Women who are pregnant or nursing.
  13. Subjects who have received an experimental drug or used an experimental device within 30 days.
  14. Subjects who have a history of neuroleptic malignant syndrome.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00277654

Locations
United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267-0559
Sponsors and Collaborators
Lindner Center of HOPE
Janssen Pharmaceuticals
University of Cincinnati
Investigators
Principal Investigator: Susan L. McElroy, MD University of Cincinnati
  More Information

Publications:
Responsible Party: Lindner Center of HOPE
ClinicalTrials.gov Identifier: NCT00277654     History of Changes
Other Study ID Numbers: RIS-PAD-402
Study First Received: January 12, 2006
Last Updated: December 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Lindner Center of HOPE:
Bipolar Disorder with Concurrent Moderately Severe Anxiety and Lifetime Panic or Generalized Anxiety Disorder

Additional relevant MeSH terms:
Anxiety Disorders
Bipolar Disorder
Disease
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Pathologic Processes
Risperidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 20, 2014