Back to resultsRapid Dose Escalation of Quetiapine Versus Conventional Escalation in Acute Schizophrenic Patients
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
IR (Immediate-Release) quetiapine fumarate (drug)
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia
Eligibility Criteria
Inclusion Criteria: Men and women age ≥18 to ≤65 years with acute schizophrenia Provision of written informed consent prior to enrolment Exclusion Criteria: Meeting the criteria for any other (than schizophrenia) psychotic disorder not in full remission, concomitant organic mental disorder or mental retardation Patients with substance dependence Female patients who are pregnant, lactating or at risk of pregnancy
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Outcomes
Primary Outcome Measures
Proportion of patients who discontinue the study treatment due to adverse events (AEs) during the first week (day 1 to day 7) of treatment
Secondary Outcome Measures
Safety and Tolerability
Number and type of adverse events
Changes in vital signs and weight
Clinically significant changes in ECG (reported as AE)
Change of Simpson-Angus Scale (SAS) score
Change of Barnes Akathisia Rating Scale (BARS) score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00254787
Brief Title
Rapid Dose Escalation of Quetiapine Versus Conventional Escalation in Acute Schizophrenic Patients
Official Title
Rapid Dose Escalation of Quetiapine Versus Conventional Escalation in the Treatment of Patients With Acute Schizophrenia - a Multicentre, Double-Blind, Parallel Group, Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to compare the safety and tolerability of IR (Immediate-Release) quetiapine in a rapid escalation scheme with to the current approved label titration.
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 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
IR (Immediate-Release) quetiapine fumarate (drug)
Primary Outcome Measure Information:
Title
Proportion of patients who discontinue the study treatment due to adverse events (AEs) during the first week (day 1 to day 7) of treatment
Secondary Outcome Measure Information:
Title
Safety and Tolerability
Title
Number and type of adverse events
Title
Changes in vital signs and weight
Title
Clinically significant changes in ECG (reported as AE)
Title
Change of Simpson-Angus Scale (SAS) score
Title
Change of Barnes Akathisia Rating Scale (BARS) score
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women age ≥18 to ≤65 years with acute schizophrenia
Provision of written informed consent prior to enrolment
Exclusion Criteria:
Meeting the criteria for any other (than schizophrenia) psychotic disorder not in full remission, concomitant organic mental disorder or mental retardation
Patients with substance dependence
Female patients who are pregnant, lactating or at risk of pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Germany Medical Director
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Berlin
Country
Germany
Facility Name
Research Site
City
Cologne
Country
Germany
Facility Name
Research Site
City
Essen
Country
Germany
Facility Name
Research Site
City
Hamburg
Country
Germany
Facility Name
Research Site
City
Jena
Country
Germany
Facility Name
Research Site
City
Werneck
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Rapid Dose Escalation of Quetiapine Versus Conventional Escalation in Acute Schizophrenic Patients
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