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Efficacy and Safety of Utapine vs. Seroquel in Patients With Bipolar Mania (UtapMani)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Taichung Veterans General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Taichung Veterans General Hospital
ClinicalTrials.gov Identifier:
NCT01043679
First received: January 6, 2010
Last updated: January 14, 2010
Last verified: January 2010
History of Changes
  Purpose

The goal of this research is to evaluate the safety as well as effectiveness of Utapine and Seroquel in bipolar I disorder patients.


Condition Intervention Phase
Bipolar, Mania
Utapine
Seroquel
 Drug: Utapine
Drug: Seroquel
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized Open-label Active-controlled Study to Evaluate the Efficacy and Safety of Utapine Versus Seroquel in Patients With Bipolar Mania

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Taichung Veterans General Hospital:

Estimated Enrollment: 40
Study Start Date: July 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Seroquel
Efficacy and Safety of Seroquel
 Drug: Seroquel
Efficacy and Safety of Seroquel
Active Comparator: Utapine
Efficacy and Safety of Utapine
 Drug: Utapine
Efficacy and Safety of Utapine

Detailed Description:

Utapine and Serquel belong to anti-bipolar medication family, both are approved by DOH (Department of Health, Taiwan), both has same ingredient but different manufacture. From clinical trial reports, both has excellent effectiveness and safety. The goal of this research is to evaluate the safety as well as effectiveness of Utapine and Seroquel in bipolar I disorder patients for different ingredient and different manufacture.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female age 18-65 years with diagnosis of bipolar I disorder who will be included by DSM-IV criteria made at least one manic or mixepisode record before study entry.
  2. Having a minimum score of 20 on the Young Mania Rating Scale (YMRS), plus a score of at least 4 on two of the core YMRS items of Irritability,Speech, Content, and Disruptive/Aggressive Behavior.
  3. At least 4 will be on the Severity of Illness item of the Clinical Global ImpressionsNBipolar(CGINBP)assessment tool.
  4. Patient with good compliance to study medicine and adherence to study protocol.

Exclusion Criteria:

  1. Had received treatment with clozapine within 28 days of the start of the trial.
  2. Had been hospitalised for 3 weeks or longer for the index manic episode.
  3. DSM-IV criteria for rapid cycling or a current mixed episode.
  4. Intolerance or lack of response to quetiapine or clozapine before this trial be diagnosed by investigator.
  5. Neurodegenerative disease eg:Parkinson desease、Huntington disease、Pick's disease.
  6. Medicine or drugs which can change mental condition be judged by investigator.
  7. EKG abnormality
  8. Drug or alcohol abuser
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01043679

Contacts
Contact: Chin-Hong Chan, MD., MS. 886-4-23592525 ext 3407
Contact: Tsuo-Hung Lan, MD.,PhD. 886-4-23592525 ext 3460 tosafish@hotmail.com

Locations
Taiwan
Taichung Veterans General Hospital Recruiting
Taichung City, Taiwan, 40705
Contact: Chin-Hong Chan, MD., MS.     886-4-23592525 ext 3407        
Contact: Tso-Hung Lan, MD.,PhD.     886-4-23592525 ext 3460     tosafish@hotmail.com    
Sponsors and Collaborators
Taichung Veterans General Hospital
Investigators
Principal Investigator: Chin-Hong Chan, MD.,MS. Taichung Veterans General Hospital
  More Information

No publications provided

Responsible Party: IRB TCVGH, Taichung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT01043679     History of Changes
Other Study ID Numbers: 01122009/S09070
Study First Received: January 6, 2010
Last Updated: January 14, 2010
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Taichung Veterans General Hospital:
Bipolar, Mania
Utapine
Seroquel

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 16, 2013