Study of Risperidone Monotherapy in Ambulatory Bipolar Disorder With Concurrent Moderately Severe Anxiety and Lifetime Panic or Generalized Anxiety Disorder

NCT00277654 | Completed Phase 3

• 1 other identifier: RIS-PAD-402
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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 disorder with panic disorder or generalized anxiety disorder. Risperidone is currently approved by the United States Food and Drug Administration (FDA) for the treatment of schizophrenia and bipolar mania. Risperidone is not currently FDA approved for the treatment of bipolar hypomania with or without panic disorder or generalized anxiety disorder (the condition being investigated in this study).

Conditions

Bipolar Disorder; Anxiety Disorder

Keywords

Bipolar Disorder with Concurrent Moderately Severe Anxiety and Lifetime Panic or Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

• Clinical Global Improvement-21 Anxiety scale (CGI-21 Anxiety)

  weekly

Secondary Outcomes (1)

• Hamilton Anxiety scale (HAM-A)

  weekly

Study Arms (2)

Risperidone

ACTIVE COMPARATOR

Drug: Risperidone

Sugar pill

PLACEBO COMPARATOR

Drug: Risperidone

Interventions

Risperidone DRUG

risperidone 0.5mg up to 4mg daily vs. placebo

Also known as: Risperidal

Risperidone; Sugar pill

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lindner Center of HOPE: lead
• Janssen Pharmaceuticals: collaborator
• University of Cincinnati: collaborator

Study Sites (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267-0559, United States

Location

Related Publications (1)

• Sheehan DV, McElroy SL, Harnett-Sheehan K, Keck PE Jr, Janavs J, Rogers J, Gonzalez R, Shivakumar G, Suppes T. Randomized, placebo-controlled trial of risperidone for acute treatment of bipolar anxiety. J Affect Disord. 2009 Jun;115(3):376-85. doi: 10.1016/j.jad.2008.10.005. Epub 2008 Nov 29.

  PMID: 19042026 RESULT

MeSH Terms

Conditions

Bipolar Disorder; Anxiety Disorders; Generalized Anxiety Disorder

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

• Susan L. McElroy, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2006
• First Posted: January 16, 2006
• Study Start: February 1, 2004
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: December 13, 2011

Record last verified: 2011-12

Locations

US (1)