Back to resultsFast Titration Of Quetiapine Versus Currently Approved Titration
Primary Purpose
Psychotic Disorders
Status
Completed
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
Quetiapine
Sponsored by
About this trial
This is an interventional treatment trial for Psychotic Disorders focused on measuring Schizophrenia, Schizoaffective disorder
Eligibility Criteria
Inclusion Criteria: Signed informed consent, male or female between 18 and 60 years old, having acute exacerbation of their schizophrenia or schizoaffective disorder requiring admission to hospital. Should stay in hospital for at least 7 days. Exclusion Criteria: Patients treated with Risperdal consta or Clozapine last 28 days, pregnancy or breast-feeding, patients known to be intolerant or unresponsive to quetiapine, known arrhythmia, other serious medical conditions.
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Outcomes
Primary Outcome Measures
Proportion of patients with moderate and severe adverse events
Secondary Outcome Measures
Mean daily level of somnolence and orthostatic dizziness as rated on AE intensity scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00254813
Brief Title
Fast Titration Of Quetiapine Versus Currently Approved Titration
Official Title
Fast Titration Of Quetiapine Versus Currently Approved Titration: A Randomised, Multicentre, Parallel Group Open Trial In Schizophrenia And Schizoaffective Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of a more rapid dose titration in acute schizophrenic patients compared to the conventional titration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders
Keywords
Schizophrenia, Schizoaffective disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Quetiapine
Primary Outcome Measure Information:
Title
Proportion of patients with moderate and severe adverse events
Secondary Outcome Measure Information:
Title
Mean daily level of somnolence and orthostatic dizziness as rated on AE intensity scale
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed informed consent, male or female between 18 and 60 years old, having acute exacerbation of their schizophrenia or schizoaffective disorder requiring admission to hospital. Should stay in hospital for at least 7 days.
Exclusion Criteria:
Patients treated with Risperdal consta or Clozapine last 28 days, pregnancy or breast-feeding, patients known to be intolerant or unresponsive to quetiapine, known arrhythmia, other serious medical conditions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Norway Medical Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Arendal
Country
Norway
Facility Name
Research Site
City
Klepp Stasjon
Country
Norway
Facility Name
Research Site
City
Kristiansand
Country
Norway
Facility Name
Research Site
City
Nesttun
Country
Norway
Facility Name
Research Site
City
Oslo
Country
Norway
Facility Name
Research Site
City
Ottestad
Country
Norway
Facility Name
Research Site
City
Ålesund
Country
Norway
12. IPD Sharing Statement
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Fast Titration Of Quetiapine Versus Currently Approved Titration
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