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A Study of Risperidone Monotherapy in Bipolar Anxiety | Clinical Trials | Clareo Health

COMPLETEDPHASE4

A Study of Risperidone Monotherapy in Bipolar Anxiety

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

NCT00167479•University of South Florida

View on ClinicalTrials.gov

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.

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+4 more criteria

Locations (3)

University of South Florida Psychiatry Center

Tampa, Florida, United States

University of Cincinatti

Cincinnati, Ohio, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Key Dates

Start Date

September 1, 2003

Completion Date

September 1, 2006

Last Updated

September 11, 2006

Enrollment

Estimated participants

Conditions

Bipolar DisorderPanic DisorderGeneralized Anxiety Disorder

Interventions

risperidone (Risperdal)

DRUG

University of Iowa Interventional Psychiatry Service Patient Registry

NCT04480918

Treatment Resistant DepressionMajor Depressive Episode+5 more

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RECRUITINGNA

Transcranial Alternating Current Stimulation for Generalized Anxiety Disorder and Insomnia: An Open-Label Pilot Study

NCT07429578

Generalized Anxiety Disorder (GAD)Chronic Insomnia

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 11, 2006Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Risperidone Monotherapy in Bipolar Anxiety

Inclusion Criteria

Exclusion Criteria

University of Iowa Interventional Psychiatry Service Patient Registry

Transcranial Alternating Current Stimulation for Generalized Anxiety Disorder and Insomnia: An Open-Label Pilot Study

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

Internet-Delivered Cognitive Behavioral Intervention for Youths With Anxiety Disorders

Epigenetic Enhancement of Cognitive Training in Aging Mood Disorder Populations

CBT-CP for Veterans With SMI