Risperidone Plus Mood Stabilizer in Treatment of Mixed Mania | NCT00294255

Studies
Risperidone Plus Mood Stabilizer in Treatment of Mixed Mania

NCT00294255

Sponsor

The University of Texas Health Science Center at San Antonio

Status

Completed

Last Update Posted

Jun 14, 2018Actual

Enrollment

45Actual

Phase

Phase 4

Conditions

Bipolar Disorder

Interventions

Risperidone

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2003

Primary Completion Date

Oct 2006Actual

Completion Date

Oct 2006Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Feb 16, 2006

First Posted Date

Feb 20, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2018

Last Update Posted Date

Jun 14, 2018Actual

Name	Class
Janssen, LP	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Risperidone	Experimental	patients will receive risperidone for up to 20 weeks	Drug: Risperidone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Risperidone	Drug	risperidone will be administered 1-3mg pills, each night, for up to 20 weeks	Risperidone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Forty percent reduction in YMRS		20 weeks

Secondary Outcomes

Measure	Description	Time Frame
twenty percent reduction in MADRS		20 weeks
Remission rate, defined as final score of plus or minus eight on YMRS and MADRS		20 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

DSM IV diagnosis of bipolar disorder, currently manic, or mixed manic
YMRS score>/= 16
One or more of following:
1. 3 MADRS depression items scoring >/=3
2. 3 BISS depression items scoring >/=3
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:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vivek Singh, MD	UT-SanAntonio	Study Director
Charles Bowden, MD	UT San Antonio	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Texas Health Science Center		San Antonio	Texas	78229	United States

Condition Browse Module

MeSH Terms

ID	Term
D001714	Bipolar Disorder
D003863	Depression

Ancestor Terms

ID	Term
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders
D001523	Mental Disorders
D001526	Behavioral Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D018967	Risperidone

Ancestor Terms

ID	Term
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided