## Protocol Section
### Identification Module
**NCT ID:** NCT00167479

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 101541d
#### Organization
**Class:** OTHER
**Full Name:** University of South Florida
#### Secondary ID Infos
**ID:** RIS-BIP-408
### Status Module
#### Completion Date
**Date:** 2006-09

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2006-09-11

**Type:** ESTIMATED

**Last Update Submit Date:** 2006-09-08

**Overall Status:** COMPLETED

#### Start Date
**Date:** 2003-09

**Status Verified Date:** 2006-09

#### Study First Post Date
**Date:** 2005-09-14
**Type:** ESTIMATED
**Study First Submit Date:** 2005-09-10
**Study First Submit QC Date:** 2005-09-12
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Janssen, LP

#### Lead Sponsor

**Class:** OTHER

**Name:** University of South Florida

### Description Module

**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.

### Conditions Module

**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

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 60

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** risperidone (Risperdal)

**Type:** DRUG

### Outcomes Module

#### 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

### Eligibility Module

**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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Tampa

**Country:** United States

**Facility:** University of South Florida Psychiatry Center

**State:** Florida

**Zip:** 33613-4788

**Location 2:**

**City:** Cincinatti

**Country:** United States

**Facility:** University of Cincinatti

**State:** Ohio

**Location 3:**

**City:** Dallas

**Country:** United States

**Facility:** University of Texas Southwestern Medical Center

**State:** Texas

#### Overall Officials

**Official 1:**

**Affiliation:** University of South Florida College of Medicine

**Name:** David V. Sheehan, MD, MBA

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** University of Cincinatti, Department of Psychiatry

**Name:** Susan L. McElroy, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 3:**

**Affiliation:** University of Texas Southwestern Medical Center

**Name:** Trisha - Suppes, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 4:**

**Affiliation:** University of Cincinatti, Department of Psychiatry

**Name:** Paul E. Keck, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001523

- Term: Mental Disorders

- ID: D000068105

- Term: Bipolar and Related Disorders

- ID: D000019964

- Term: Mood Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4324

- Name: Anxiety Disorders

- Relevance: HIGH

- As Found: Anxiety Disorder

- ID: M4996

- Name: Bipolar Disorder

- Relevance: HIGH

- As Found: Bipolar Disorder

- ID: M18970

- Name: Panic Disorder

- Relevance: HIGH

- As Found: Panic Disorder

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M226

- Name: Bipolar and Related Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M21835

- Name: Mood Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001008

- Term: Anxiety Disorders

- ID: D000001714

- Term: Bipolar Disorder

- ID: D000016584

- Term: Panic Disorder

### Intervention Browse Module - Ancestors

- ID: D000012702

- Term: Serotonin Antagonists

- ID: D000018490

- Term: Serotonin Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000014150

- Term: Antipsychotic Agents

- ID: D000014149

- Term: Tranquilizing Agents

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000011619

- Term: Psychotropic Drugs

- ID: D000018492

- Term: Dopamine Antagonists

- ID: D000015259

- Term: Dopamine Agents

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: PsychDr

- Name: Psychotropic Drugs

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: CaAg

- Name: Cardiotonic Agents

### Intervention Browse Module - Browse Leaves

- ID: M20999

- Name: Risperidone

- Relevance: HIGH

- As Found: Evening

- ID: M15512

- Name: Serotonin

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

- ID: M16904

- Name: Antipsychotic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M14474

- Name: Psychotropic Drugs

- Relevance: LOW

- As Found: Unknown

- ID: M7473

- Name: Dopamine

- Relevance: LOW

- As Found: Unknown

- ID: M20596

- Name: Dopamine Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M17962

- Name: Dopamine Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000018967

- Term: Risperidone

### Misc Info Module

- Version Holder: 2024-05-24
