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

• Sponsor: Taichung Veterans General Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01043679
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 11
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bipolar, Mania; Utapine; Seroquel	Drug: Utapine; Drug: Seroquel	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Randomized Open-label Active-controlled Study to Evaluate the Efficacy and Safety of Utapine Versus Seroquel in Patients With Bipolar Mania
• Study Start Date: Jul 1, 2009
• Anticipated Primary Completion Date: Jun 1, 2010
• Anticipated Study Completion Date: Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Seroquel Efficacy and Safety of Seroquel	Drug: Seroquel; Efficacy and Safety of Seroquel
Active Comparator: Utapine Efficacy and Safety of Utapine	Drug: Utapine; Efficacy and Safety of Utapine

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taichung Veterans General Hospital	Taichung City		Taiwan	40705

Sponsors and Collaborators

• Taichung Veterans General Hospital

Investigators

• Principal Investigator: Chin-Hong Chan, MD.,MS., Taichung Veterans General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01043679
• Other Study ID Numbers: 01122009/S09070
• First Posted: Jan 7, 2010
• Last Update Posted: Jan 15, 2010
• Last Verified: Jan 1, 2010

• Keywords provided by , ,: Bipolar, Mania; Utapine; Seroquel
• Additional relevant MeSH terms: Mania; Quetiapine Fumarate

Study Results

No Results Posted as of Jan 15, 2010