Status:
COMPLETED
Study of Risperidone Monotherapy in Ambulatory Bipolar Disorder With Concurrent Moderately Severe Anxiety and Lifetime Panic or Generalized Anxiety Disorder
Lead Sponsor:
Lindner Center of HOPE
Collaborating Sponsors:
Janssen Pharmaceuticals
University of Cincinnati
Conditions:
Bipolar Disorder
Anxiety Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 dis...
Detailed Description
Methods and Procedures: This is a randomized, double-blind, placebo controlled, parallel-group, 3 site, 8-week trial of risperidone monotherapy in outpatient subjects with a lifetime bipolar I, II, o...
Eligibility Criteria
Inclusion
- Subjects must be 18 years of age or older.
- 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.
- 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) .
- Subjects' bipolar symptoms must be no more than moderately severe, defined as a CGI-BP \< 4.
- Subjects' anxiety symptoms must be at least moderately severe, defined as a CGI-S \> 4.
- 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.
- Subjects or their legally authorized representative must sign the Informed Consent Document after the nature of the trial has been fully explained.
- 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
- Subjects who do not have lifetime bipolar disorder by DSM-IV-TR (text revision) criteria.
- Subjects who do not have lifetime panic disorder or generalized anxiety disorder by DSM-IV-TR criteria.
- 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.
- Subjects whose bipolar symptoms are presently more than moderately severe (CGI-BP \> 5).
- Subjects whose anxiety symptoms are presently less than moderately severe (CGI \< 3).
- Subjects with clinically significant suicidal or homicidal ideation.
- Subjects with current psychotic symptoms.
- 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).
- 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.
- Subjects with a clinically significant abnormality in their prestudy physical exam, vital signs, EKG, or laboratory tests.
- Subjects who are allergic to or who have demonstrated hypersensitivity to risperidone.
- Women who are pregnant or nursing.
- Subjects who have received an experimental drug or used an experimental device within 30 days.
- Subjects who have a history of neuroleptic malignant syndrome.
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT00277654
Start Date
February 1 2004
End Date
March 1 2009
Last Update
December 13 2011
Active Locations (1)
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1
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267-0559