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Risperidone Plus Mood Stabilizer in Treatment of Mixed Mania

This study has been completed.
Sponsor:
Collaborator:
Janssen, LP
Information provided by (Responsible Party):
Vivek Singh, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00294255
First received: September 13, 2005
Last updated: February 27, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder
Drug: Risperidone
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Risperidone Plus Mood Stabilizer in the Treatment of Mixed Mania

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • Forty percent reduction in YMRS [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • twenty percent reduction in MADRS [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Remission rate, defined as final score of plus or minus eight on YMRS and MADRS [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: March 2003
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Risperidone
patients will receive risperidone for up to 20 weeks
Drug: Risperidone
risperidone will be administered 1-3mg pills, each night, for up to 20 weeks
Other Name: risperdal

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00294255

Locations
United States, Texas
University of Texas Health Science Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Janssen, LP
Investigators
Study Director: Vivek Singh, MD UT-SanAntonio
Principal Investigator: Charles Bowden, MD UT San Antonio
  More Information

No publications provided

Responsible Party: Vivek Singh, principal investigator, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00294255     History of Changes
Other Study ID Numbers: RIS-USA-T290
Study First Received: September 13, 2005
Last Updated: February 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center at San Antonio:
mixed mania
depression
irritability

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Risperidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 24, 2014