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

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lindner Center of HOPE
• Collaborators: Janssen Pharmaceuticals; University of Cincinnati
• Treatments: Risperidone

Criteria

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 Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (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, 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 (text revision) 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; or 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.

11. Subjects who are allergic to or who have demonstrated hypersensitivity to risperidone.

12. Women who are pregnant or nursing.

13. Subjects who have received an experimental drug or used an experimental device within 30 days.

14. Subjects who have a history of neuroleptic malignant syndrome.