Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of Risperidone Monotherapy in Bipolar Anxiety

This study has been completed.
Sponsor:
Collaborator:
Janssen, LP
Information provided by:
University of South Florida
ClinicalTrials.gov Identifier:
NCT00167479
First received: September 10, 2005
Last updated: September 8, 2006
Last verified: September 2006
  Purpose

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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by University of South Florida:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 60
Study Start Date: September 2003
Estimated Study Completion Date: September 2006
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.

  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 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.
  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: NCT00167479

Locations
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
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00167479     History of Changes
Other Study ID Numbers: 101541d, RIS-BIP-408
Study First Received: September 10, 2005
Last Updated: September 8, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Florida:
Bipolar Anxiety
Bipolar Disorder
Anxiety
Panic Disorder
Generalized Anxiety Disorder
GAD
Risperidone
Double-Blind
Placebo Controlled

Additional relevant MeSH terms:
Anxiety Disorders
Bipolar Disorder
Disease
Panic Disorder
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 November 24, 2014