ClinicalTrials.Veeva

Menu

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

T

Taichung Veterans General Hospital

Status and phase

Unknown
Phase 4

Conditions

Bipolar, Mania
Utapine
Seroquel

Treatments

Drug: Utapine
Drug: Seroquel

Study type

Interventional

Funder types

Other

Identifiers

NCT01043679
01122009/S09070

Details and patient eligibility

About

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

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

Seroquel
Active Comparator group
Description:
Efficacy and Safety of Seroquel
Treatment:
Drug: Seroquel
Utapine
Active Comparator group
Description:
Efficacy and Safety of Utapine
Treatment:
Drug: Utapine

Trial contacts and locations

1

Loading...

Central trial contact

Chin-Hong Chan, MD., MS.; Tsuo-Hung Lan, MD.,PhD.

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems