Efficacy and Safety of Utapine vs. Seroquel in Patients With Bipolar Mania
Information source: Taichung Veterans General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar, Mania; Utapine; Seroquel
Intervention: Utapine (Drug); Seroquel (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Taichung Veterans General Hospital Official(s) and/or principal investigator(s):
Chin-Hong Chan, MD.,MS., Principal Investigator, Affiliation: Taichung Veterans General Hospital
Overall contact:
Chin-Hong Chan, MD., MS., Phone: 886-4-23592525, Ext: 3407
Summary
The goal of this research is to evaluate the safety as well as effectiveness of Utapine and
Seroquel in bipolar I disorder patients.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Chin-Hong Chan, MD., MS., Phone: 886-4-23592525, Ext: 3407
Taichung Veterans General Hospital, Taichung City 40705, Taiwan; Recruiting
Chin-Hong Chan, MD., MS., Phone: 886-4-23592525, Ext: 3407
Tso-Hung Lan, MD.,PhD., Phone: 886-4-23592525, Ext: 3460, Email: tosafish@hotmail.com
Additional Information
Starting date: July 2009
Last updated: January 14, 2010
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