Clinical trial NCT00167479: A Study of Risperidone Monotherapy in Bipolar Anxiety
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
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
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: Janssen, LP
First posted: 2005-09-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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 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.
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.

Primary outcomes:
measure: Clinician Global Improvement Scale (CGI-21)
Secondary outcomes:
measure: Sheehan Panic Disorder Scale (SPS)
measure: The Psychic and Somatic factors of the HAM-A
measure: Young Mania Rating Scale, Total Score
measure: Inventory of Depressive Symptoms, Total Score
measure: Patient Global Improvement Scale (PGI-21)
measure: The Clinician Global Improvement-Bipolar (CGI-BP)
measure: The Family Impact Scale (FIS)
measure: The Sheehan Disability Scale - Total Disability Score, Work Disability Score, Social Disability Score, Family Disability Score
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida Psychiatry Center
state: Florida
city: Cincinatti
country: United States
facility: University of Cincinatti
state: Ohio
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of South Florida College of Medicine
name: David V. Sheehan, MD, MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cincinatti, Department of Psychiatry
name: Susan L. McElroy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas Southwestern Medical Center
name: Trisha - Suppes, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cincinatti, Department of Psychiatry
name: Paul E. Keck, MD
role: PRINCIPAL_INVESTIGATOR
References: