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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bipolar, Mania, Utapine, Seroquel

Intervention / Treatment
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* Drug: Utapine
* Drug: Seroquel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Seroquel<br>Efficacy and Safety of Seroquel | Drug: Seroquel<br>* Efficacy and Safety of Seroquel<br>|
| Active Comparator: Utapine<br>Efficacy and Safety of Utapine | Drug: Utapine<br>* Efficacy and Safety of Utapine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bipolar, Mania, Utapine, Seroquel