A Study of Risperidone Monotherapy in Bipolar Anxiety

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00167479
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : September 11, 2006
Janssen, LP
Information provided by:
University of South Florida

Brief 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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Panic Disorder Generalized Anxiety Disorder Drug: risperidone (Risperdal) Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : September 2003
Estimated Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Risperidone
U.S. FDA Resources

Primary Outcome Measures :
  1. Clinician Global Improvement Scale (CGI-21)

Secondary Outcome Measures :
  1. Sheehan Panic Disorder Scale (SPS)
  2. The Psychic and Somatic factors of the HAM-A
  3. Young Mania Rating Scale, Total Score
  4. Inventory of Depressive Symptoms, Total Score
  5. Patient Global Improvement Scale (PGI-21)
  6. The Clinician Global Improvement-Bipolar (CGI-BP)
  7. The Family Impact Scale (FIS)
  8. The Sheehan Disability Scale - Total Disability Score, Work Disability Score, Social Disability Score, Family Disability Score

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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, double 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 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; 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00167479

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
Sponsors and Collaborators
University of South Florida
Janssen, LP
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 Identifier: NCT00167479     History of Changes
Other Study ID Numbers: 101541d
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: September 11, 2006
Last Verified: September 2006

Keywords provided by University of South Florida:
Bipolar Anxiety
Bipolar Disorder
Panic Disorder
Generalized Anxiety Disorder
Placebo Controlled

Additional relevant MeSH terms:
Anxiety Disorders
Bipolar Disorder
Panic Disorder
Pathologic Processes
Mental Disorders
Bipolar and Related Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents