Bipolar, Mania | Efficacy and Safety of Utapine vs. Seroquel in Patients With Bipolar Mania
Bipolar, Mania research study
What is the primary objective of this study?
The goal of this research is to evaluate the safety as well as effectiveness of Utapine and Seroquel in bipolar I disorder patients.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:UtapineEfficacy and Safety of Utapine
Drug:SeroquelEfficacy and Safety of Seroquel
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
SeroquelEfficacy and Safety of Seroquel
UtapineEfficacy and Safety of Utapine
Start Date: July 2009
Completed Date: June 2010
Phase: Phase 4
Study sponsors, principal investigator, and references
Principal Investigator: Chin-Hong Chan, MD.,MS.
Lead Sponsor: Taichung Veterans General Hospital