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Completed

NCT Number: NCT00294255

Risperidone Plus Mood Stabilizer in Treatment of Mixed Mania

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.

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Key information

Conditions

Bipolar Disorder Behavior Behavioral Symptoms Bipolar and Related Disorders Depression Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Texas Health Science Center

San Antonio, Texas, 78229, United States

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Risperidone

Drug

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

Other names: risperdal

Primary outcomes

  1. Forty percent reduction in YMRS

    Time frame: 20 weeks

Secondary outcomes

  1. twenty percent reduction in MADRS

    Time frame: 20 weeks

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

    Time frame: 20 weeks

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • Janssen, LP

Registry information

Official study title

Risperidone Plus Mood Stabilizer in the Treatment of Mixed Mania

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Feb 20, 2006
Registry last updated
Jun 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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