Efficacy and Safety of Utapine vs. Seroquel in Patients With Bipolar Mania (UtapMani)
Primary Purpose
Bipolar, Mania, Utapine, Seroquel
Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Utapine
Seroquel
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar, Mania focused on measuring Bipolar, Mania, Utapine, Seroquel
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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.
- At least 4 will be on the Severity of Illness item of the Clinical Global ImpressionsNBipolar(CGINBP)assessment tool.
- Patient with good compliance to study medicine and adherence to study protocol.
Exclusion Criteria:
- Had received treatment with clozapine within 28 days of the start of the trial.
- Had been hospitalised for 3 weeks or longer for the index manic episode.
- DSM-IV criteria for rapid cycling or a current mixed episode.
- Intolerance or lack of response to quetiapine or clozapine before this trial be diagnosed by investigator.
- Neurodegenerative disease eg:Parkinson desease、Huntington disease、Pick's disease.
- Medicine or drugs which can change mental condition be judged by investigator.
- EKG abnormality
- Drug or alcohol abuser
Sites / Locations
- Taichung Veterans General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Seroquel
Utapine
Arm Description
Efficacy and Safety of Seroquel
Efficacy and Safety of Utapine
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01043679
First Posted
January 6, 2010
Last Updated
January 14, 2010
Sponsor
Taichung Veterans General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01043679
Brief Title
Efficacy and Safety of Utapine vs. Seroquel in Patients With Bipolar Mania
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
June 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Taichung Veterans General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal of this research is to evaluate the safety as well as effectiveness of Utapine and Seroquel in bipolar I disorder patients.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar, Mania, Utapine, Seroquel
Keywords
Bipolar, Mania, Utapine, Seroquel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Seroquel
Arm Type
Active Comparator
Arm Description
Efficacy and Safety of Seroquel
Arm Title
Utapine
Arm Type
Active Comparator
Arm Description
Efficacy and Safety of Utapine
Intervention Type
Drug
Intervention Name(s)
Utapine
Intervention Description
Efficacy and Safety of Utapine
Intervention Type
Drug
Intervention Name(s)
Seroquel
Intervention Description
Efficacy and Safety of Seroquel
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
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.
At least 4 will be on the Severity of Illness item of the Clinical Global ImpressionsNBipolar(CGINBP)assessment tool.
Patient with good compliance to study medicine and adherence to study protocol.
Exclusion Criteria:
Had received treatment with clozapine within 28 days of the start of the trial.
Had been hospitalised for 3 weeks or longer for the index manic episode.
DSM-IV criteria for rapid cycling or a current mixed episode.
Intolerance or lack of response to quetiapine or clozapine before this trial be diagnosed by investigator.
Neurodegenerative disease eg:Parkinson desease、Huntington disease、Pick's disease.
Medicine or drugs which can change mental condition be judged by investigator.
EKG abnormality
Drug or alcohol abuser
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chin-Hong Chan, MD., MS.
Phone
886-4-23592525
Ext
3407
First Name & Middle Initial & Last Name or Official Title & Degree
Tsuo-Hung Lan, MD.,PhD.
Phone
886-4-23592525
Ext
3460
Email
tosafish@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chin-Hong Chan, MD.,MS.
Organizational Affiliation
Taichung Veterans General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taichung Veterans General Hospital
City
Taichung City
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chin-Hong Chan, MD., MS.
Phone
886-4-23592525
Ext
3407
First Name & Middle Initial & Last Name & Degree
Tso-Hung Lan, MD.,PhD.
Phone
886-4-23592525
Ext
3460
Email
tosafish@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Utapine vs. Seroquel in Patients With Bipolar Mania
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