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

Phase 4

• Conditions: Bipolar, Mania; Utapine; Seroquel
• Interventions: Drug: Utapine; Drug: Seroquel

• Registration Number: NCT01043679
• Lead Sponsor: Taichung Veterans General Hospital

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.

Study Timeline

• Study Start: 2009-07
• Status Verified: 2010-01
• Study First Submitted: 2010-01-06
• Study First Submitted QC: 2010-01-06
• Study First Posted: 2010-01-07
• Last Update Submitted: 2010-01-14
• Last Update Posted: 2010-01-15
• Primary Completion: 2010-06
• Study Completion: 2010-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Utapine	Utapine	Efficacy and Safety of Utapine
Seroquel	Seroquel	Efficacy and Safety of Seroquel

Trial Locations

Locations (1)

Taichung Veterans General Hospital; 🇨🇳 Taichung City, Taiwan