A Study of Risperidone Monotherapy in Bipolar Anxiety

NCT00167479 | Completed Phase 4

• 2 other identifiers: 101541dRIS-BIP-408
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Bipolar Disorder; Panic Disorder; Generalized Anxiety Disorder

Keywords

Bipolar Anxiety; Bipolar Disorder; Anxiety; Panic Disorder; Generalized Anxiety Disorder; GAD; Risperidone; Double-Blind; Placebo Controlled

Outcome Measures

Primary Outcomes (1)

• Clinician Global Improvement Scale (CGI-21)

Secondary Outcomes (8)

• 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)

Interventions

risperidone (Risperdal) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Florida: lead
• Janssen, LP: collaborator

Study Sites (3)

University of South Florida Psychiatry Center

Tampa, Florida, 33613-4788, United States

Location

University of Cincinatti

Cincinnati, Ohio, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Panic Disorder; Generalized Anxiety Disorder; Anxiety Disorders

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 10, 2005
• First Posted: September 14, 2005
• Study Start: September 1, 2003
• Study Completion: September 1, 2006
• Last Updated: September 11, 2006

Record last verified: 2006-09

Locations

US (3)