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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01043679

Acronym

UtapMani

Enrollment

Registered

2010-01-07

Start date

2009-07-31

Completion date

2010-06-30

Last updated

2010-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar, Mania, Seroquel, Utapine

Keywords

Bipolar, Mania, Utapine, Seroquel

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.

Interventions

DRUGUtapine

Efficacy and Safety of Utapine

DRUGSeroquel

Efficacy and Safety of Seroquel

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Countries

Taiwan

Contacts

Primary ContactChin-Hong Chan, MD., MS.

886-4-23592525

Backup ContactTsuo-Hung Lan, MD.,PhD.

tosafish@hotmail.com886-4-23592525

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026