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

• Status: Unknown status
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this research is to evaluate the safety as well as effectiveness of Utapine and Seroquel in bipolar I disorder patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Taichung Veterans General Hospital
• Treatments: Quetiapine Fumarate

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