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

Bipolar, Mania Clinical Trial

— UtapMani  

Official title:

A Randomized Open-label Active-controlled Study to Evaluate the Efficacy and Safety of Utapine Versus Seroquel in Patients With Bipolar Mania

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01043679
• Other study ID #: 01122009/S09070
• Status: Recruiting
• Phase: Phase 4
• First received: January 6, 2010
• Last updated: January 14, 2010
• Start date: July 2009
• Est. completion date: June 2010

Study information

• Verified date: January 2010
• Source: Taichung Veterans General Hospital
• Contact: Chin-Hong Chan, MD., MS.
• Phone: 886-4-23592525
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar, Mania
• Seroquel
• Utapine

Intervention

Drug:
• Utapine
Efficacy and Safety of Utapine
• Seroquel
Efficacy and Safety of Seroquel

Locations

Country	Name	City	State
Taiwan	Taichung Veterans General Hospital	Taichung City

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan,