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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-06-30

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.

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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.

Conditions

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Bipolar, Mania Utapine Seroquel

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Seroquel

Efficacy and Safety of Seroquel

Group Type ACTIVE_COMPARATOR

Seroquel

Intervention Type DRUG

Efficacy and Safety of Seroquel

Utapine

Efficacy and Safety of Utapine

Group Type ACTIVE_COMPARATOR

Utapine

Intervention Type DRUG

Efficacy and Safety of Utapine

Interventions

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Utapine

Efficacy and Safety of Utapine

Intervention Type DRUG

Seroquel

Efficacy and Safety of Seroquel

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes