NCT00294255

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2003

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

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

March 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 20, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

June 14, 2018

Status Verified

February 1, 2013

Enrollment Period

3.6 years

First QC Date

September 13, 2005

Last Update Submit

June 12, 2018

Conditions

Bipolar Disorder

Keywords

mixed maniadepressionirritability

Outcome Measures

Primary Outcomes (1)

  • Forty percent reduction in YMRS

    20 weeks

Secondary Outcomes (2)

  • twenty percent reduction in MADRS

    20 weeks

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

    20 weeks

Study Arms (1)

Risperidone

EXPERIMENTAL

patients will receive risperidone for up to 20 weeks

Drug: Risperidone

Interventions

RisperidoneDRUG

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

Also known as: risperdal
Risperidone

Eligibility Criteria

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

You may qualify if:

  • DSM IV diagnosis of bipolar disorder, currently manic, or mixed manic
  • YMRS score\>/= 16
  • One or more of following:
  • MADRS depression items scoring \>/=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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Science Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Bipolar DisorderDepression

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Vivek Singh, MD

    UT-SanAntonio

    STUDY DIRECTOR

  • Charles Bowden, MD

    UT San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

February 20, 2006

Study Start

March 1, 2003

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

June 14, 2018

Record last verified: 2013-02

Locations

US(1)