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Search / Trial NCT00294255

Risperidone Plus Mood Stabilizer in Treatment of Mixed Mania

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO · Feb 16, 2006

Trial Information

Current as of May 17, 2025

Completed

Keywords

Mixed Mania Depression Irritability

ClinConnect Summary

* 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.

Gender

ALL

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:
  • -

About The University Of Texas Health Science Center At San Antonio

The University of Texas Health Science Center at San Antonio (UT Health San Antonio) is a leading academic medical institution dedicated to advancing health through education, research, and patient care. As a prominent sponsor of clinical trials, UT Health San Antonio focuses on innovative medical research aimed at improving health outcomes across diverse populations. With a commitment to excellence, the institution fosters collaboration among its multidisciplinary teams to explore cutting-edge therapies and interventions. Through rigorous scientific inquiry and ethical practices, UT Health San Antonio strives to make meaningful contributions to the field of medicine and enhance the quality of life for patients.

Locations

San Antonio, Texas, United States

Patients applied

0 patients applied

Trial Officials

Vivek Singh, MD

Study Director

UT-SanAntonio

Charles Bowden, MD

Principal Investigator

UT San Antonio

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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