Efficacy and Safety of Utapine vs. Seroquel in Patients With Bipolar Mania
UtapMani
A Randomized Open-label Active-controlled Study to Evaluate the Efficacy and Safety of Utapine Versus Seroquel in Patients With Bipolar Mania
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2009
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 6, 2010
CompletedFirst Posted
Study publicly available on registry
January 7, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedJanuary 15, 2010
January 1, 2010
11 months
January 6, 2010
January 14, 2010
Conditions
Keywords
Study Arms (2)
Seroquel
ACTIVE COMPARATOREfficacy and Safety of Seroquel
Utapine
ACTIVE COMPARATOREfficacy and Safety of Utapine
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taichung Veterans General Hospital
Taichung, Taiwan, 40705, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chin-Hong Chan, MD.,MS.
Taichung Veterans General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 6, 2010
First Posted
January 7, 2010
Study Start
July 1, 2009
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
January 15, 2010
Record last verified: 2010-01