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Risperidone Plus Mood Stabilizer in Treatment of Mixed Mania

Primary Purpose

Bipolar Disorder

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Risperidone

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring mixed mania, depression, irritability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: DSM IV diagnosis of bipolar disorder, currently manic, or mixed manic YMRS score>/= 16 One or more of following: 3 MADRS depression items scoring >/=3 3 BISS depression items scoring >/=3 YMRS irritability and aggressive items sum score>/=4 Taking lithium, valproate or lamotrigine at stable dose for 4 wks or longer, with adequate serum level age 18 and over Male or female Inpatient or outpatient Exclusion Criteria: -

Sites / Locations

University of Texas Health Science Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Risperidone

Arm Description

patients will receive risperidone for up to 20 weeks

Outcomes

Primary Outcome Measures

Forty percent reduction in YMRS

Secondary Outcome Measures

twenty percent reduction in MADRS

Remission rate, defined as final score of plus or minus eight on YMRS and MADRS

Full Information

NCT ID

NCT00294255

First Posted

September 13, 2005

Last Updated

June 12, 2018

Sponsor

The University of Texas Health Science Center at San Antonio

Collaborators

Janssen, LP

1. Study Identification

Unique Protocol Identification Number

NCT00294255

Brief Title

Risperidone Plus Mood Stabilizer in Treatment of Mixed Mania

Official Title

Risperidone Plus Mood Stabilizer in the Treatment of Mixed Mania

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Completed

Study Start Date

March 2003 (undefined)

Primary Completion Date

October 2006 (Actual)

Study Completion Date

October 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The University of Texas Health Science Center at San Antonio

Collaborators

Janssen, LP

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The study aims to assess the efficacy and tolerability of risperidone added to lithium, valproate or lamotrigine in patients experiencing a manic episode with depressive or irritable features.

Detailed Description

The study aims to assess the efficacy and tolerability of risperidone added to lithium, valproate or lamotrigine, or any combination of the three, in patients experiencing a manic episode with depressive or irritable symptoms. To assess the back ground and baseline features associated with response/non-response to risperidone plus mood stabilizer in patients with mania with depressive or irritable features. To assess the symptomatic dimensions of response of risperidone added to mood stabilizers in patients with mania with depressive or irritable features.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bipolar Disorder

Keywords

mixed mania, depression, irritability

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Risperidone

Arm Type

Experimental

Arm Description

patients will receive risperidone for up to 20 weeks

Intervention Type

Drug

Intervention Name(s)

Risperidone

Other Intervention Name(s)

risperdal

Intervention Description

risperidone will be administered 1-3mg pills, each night, for up to 20 weeks

Primary Outcome Measure Information:

Title

Forty percent reduction in YMRS

Time Frame

20 weeks

Secondary Outcome Measure Information:

Title

twenty percent reduction in MADRS

Time Frame

20 weeks

Title

Remission rate, defined as final score of plus or minus eight on YMRS and MADRS

Time Frame

20 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vivek Singh, MD

Organizational Affiliation

UT-SanAntonio

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Charles Bowden, MD

Organizational Affiliation

UT San Antonio

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Texas Health Science Center

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

12. IPD Sharing Statement

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Risperidone Plus Mood Stabilizer in Treatment of Mixed Mania

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