- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00167479
A Study of Risperidone Monotherapy in Bipolar Anxiety
September 8, 2006 updated by: University of South Florida
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
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.
Study Overview
Status
Completed
Intervention / Treatment
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
Enrollment
60
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Tampa, Florida, United States, 33613-4788
- University of South Florida Psychiatry Center
-
-
Ohio
-
Cincinatti, Ohio, United States
- University of Cincinatti
-
-
Texas
-
Dallas, Texas, United States
- University of Texas Southwestern Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects must be 18 years of age or older.
- Subjects must have lifetime bipolar I, II, or NOS disorder as defined by 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, double barrier methods, intrauterine device) for at least one month prior to study entry and throughout the study.
Exclusion Criteria:
- Subjects who do not have lifetime bipolar disorder by DSM-IV-TR 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; 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Clinician Global Improvement Scale (CGI-21)
|
Secondary Outcome Measures
Outcome Measure |
---|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2003
Primary Completion
December 7, 2022
Study Completion
September 1, 2006
Study Registration Dates
First Submitted
September 10, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 14, 2005
Study Record Updates
Last Update Posted (Estimate)
September 11, 2006
Last Update Submitted That Met QC Criteria
September 8, 2006
Last Verified
September 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Bipolar and Related Disorders
- Disease
- Anxiety Disorders
- Bipolar Disorder
- Panic Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Dopamine Agents
- Serotonin Antagonists
- Dopamine Antagonists
- Risperidone
Other Study ID Numbers
- 101541d
- RIS-BIP-408
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Generalized Anxiety Disorder
-
ProofPilotFisher WallaceActive, not recruitingGeneralized Anxiety Disorder | Anxiety | Generalized AnxietyUnited States
-
Xijing HospitalRecruitingGeneralized Anxiety DisorderChina
-
Sichuan Jishengtang Pharmaceutical Co., Ltd.Not yet recruitingGeneralized Anxiety Disorder
-
Hospital de Clinicas de Porto AlegreRecruitingGeneralized Anxiety DisorderBrazil
-
University of California, Los AngelesMedical University of South Carolina; Massachusetts General HospitalRecruitingGeneralized Anxiety DisorderUnited States
-
Shahid Beheshti University of Medical SciencesCompletedGeneralized Anxiety DisorderIran, Islamic Republic of
-
Dr. Nazanin AlaviOnline PsychoTherapy ClinicCompletedGeneralized Anxiety DisorderCanada
-
Laureate Institute for Brain Research, Inc.National Institute of Mental Health (NIMH)CompletedGeneralized Anxiety DisorderUnited States
-
The Canadian College of Naturopathic MedicineMassachusetts General Hospital; McGill University; Mitacs; Ekhagastiftelsen; Netherlands... and other collaboratorsActive, not recruitingGeneralized Anxiety DisorderCanada
Clinical Trials on risperidone (Risperdal)
-
Zogenix, Inc.CompletedSchizophrenia | Schizoaffective DisorderUnited States
-
Janssen Korea, Ltd., KoreaCompleted
-
Xian-Janssen Pharmaceutical Ltd.Withdrawn
-
Dartmouth-Hitchcock Medical CenterJanssen, LPCompletedPsychotic Disorders | Schizophrenia | Substance Abuse | Alcohol AbuseUnited States
-
University of California, Los AngelesNational Institute of Mental Health (NIMH); Janssen Scientific Affairs, LLCCompletedSchizophreniaUnited States
-
Janssen, LPCompleted
-
University of California, Los AngelesNational Institute of Mental Health (NIMH); Janssen Scientific Affairs, LLCCompletedSchizophreniaUnited States
-
Northwell HealthNational Alliance for Research on Schizophrenia and Depression; The Zucker...TerminatedSchizophrenia | Schizoaffective Disorder | Schizophreniform Disorder | Psychotic Disorder Not Otherwise SpecifiedUnited States
-
University of ManchesterKing's College London; Cardiff University; P1vital LimitedCompletedSchizophrenia | Healthy VolunteersUnited Kingdom
-
Janssen Cilag N.V./S.A.Completed