Back to resultsFast Titration in the Treatment of Schizophrenia, Taiwan
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
Quetiapine fumarate
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia
Eligibility Criteria
Inclusion Criteria: Signed informed consent, at least 18 years old, inpatients with relapse Schizophrenia all subtypes, and with a CGI (Clinical Global Impression) score >=4. Exclusion Criteria: Pregnancy or breast-feeding, patients treated with Clozapine within 28 days of randomization, patients with a known arrhythmia, any psychotic disorders not defined in the inclusion criteria.
Sites / Locations
- Research Site
Outcomes
Primary Outcome Measures
Compare the safety and tolerability of a fast titration of quetiapine to the current titration approved by the regulatory authorities.
Secondary Outcome Measures
Assess the efficacy of a fast titration of quetiapine to the current titration approved by the regulatory authorities.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00304473
Brief Title
Fast Titration in the Treatment of Schizophrenia, Taiwan
Official Title
Fast Titration of Quetiapine Versus Conventional Titration in the Treatment of Schizophrenia/Schizoaffective Disorder: a Randomised, Parallel Group Open Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
Assess the efficacy of a fast titration of quetiapine to the current titration approved by the regulatory authorities.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Quetiapine fumarate
Primary Outcome Measure Information:
Title
Compare the safety and tolerability of a fast titration of quetiapine to the current titration approved by the regulatory authorities.
Secondary Outcome Measure Information:
Title
Assess the efficacy of a fast titration of quetiapine to the current titration approved by the regulatory authorities.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed informed consent, at least 18 years old, inpatients with relapse Schizophrenia all subtypes, and with a CGI (Clinical Global Impression) score >=4.
Exclusion Criteria:
Pregnancy or breast-feeding, patients treated with Clozapine within 28 days of randomization, patients with a known arrhythmia, any psychotic disorders not defined in the inclusion criteria.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Taiwan Medical Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Taoyuan
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Fast Titration in the Treatment of Schizophrenia, Taiwan
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