A Study of Risperidone Monotherapy in Bipolar Anxiety

Bipolar Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00167479
• Other study ID #: 101541d
• Secondary ID: RIS-BIP-408
• Status: Completed
• Phase: Phase 4
• First received: September 10, 2005
• Last updated: September 8, 2006
• Start date: September 2003
• Est. completion date: September 2006

Study information

• Verified date: September 2006
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Bipolar Disorder
• Disease
• Generalized Anxiety Disorder
• Panic Disorder

Intervention

Drug:
• risperidone (Risperdal)

Locations

Country	Name	City	State
United States	University of Cincinatti	Cincinatti	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	University of South Florida Psychiatry Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	Janssen, LP

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician Global Improvement Scale (CGI-21)
Secondary	Sheehan Panic Disorder Scale (SPS)
Secondary	The Psychic and Somatic factors of the HAM-A
Secondary	Young Mania Rating Scale, Total Score
Secondary	Inventory of Depressive Symptoms, Total Score
Secondary	Patient Global Improvement Scale (PGI-21)
Secondary	The Clinician Global Improvement-Bipolar (CGI-BP)
Secondary	The Family Impact Scale (FIS)
Secondary	The Sheehan Disability Scale - Total Disability Score, Work Disability Score, Social Disability Score, Family Disability Score