NCT00216554

Brief Summary

The purpose of this study is to evaluate effect of risperidone as a long-term combination therapy to mood stabilizers in the treatment of bipolar mania

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2004

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

January 24, 2011

Status Verified

January 1, 2011

First QC Date

September 13, 2005

Last Update Submit

January 20, 2011

Conditions

Bipolar Disorder

Keywords

BipolarrisperidoneAdjunctive therapy

Outcome Measures

Primary Outcomes (1)

  • The change in YMRS score from baseline at 6 months

Secondary Outcomes (1)

  • The change from baseline in Clinical Global Impression-Severity (CGI-S) score at 6 months; The change from baseline in HAMD score at 6 months

Interventions

risperidoneDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • In- or out-patient
  • Diagnosis of bipolar I disorder
  • most recent episode manic with or without psychotic features
  • YMRS \> 20 (manic)
  • Need antipsychotic combination on the basis of clinicians' experience

You may not qualify if:

  • Rapid cycling
  • Risk of suicide or violence
  • History of Substance dependence within 3 months
  • Comorbidities
  • Unstable medical illness
  • Previous sensitivity history to risperidone
  • Pregnant woman or those without proper contraception
  • History of clozapine and one cycle of depot use prior to entry
  • History of treatment resistance: at least two mood stabilizers
  • Prior history of active treatment with risperidone
  • As for patients having wash-out period, patients that show 25% or more decrease in YMRS at baseline as compared to that at enrollment time, should be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Janssen Korea, Ltd. Clinical Trial

    Janssen Korea, Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

September 1, 2004

Study Completion

March 1, 2006

Last Updated

January 24, 2011

Record last verified: 2011-01