Back to resultsSafety and Efficacy of Seroquel in First Episode Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Seroquel and Risperidone
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia
Eligibility Criteria
Inclusion Criteria: Age 18-35 years Meet ICD-10 criteria for schizophrenia No abnormaility on clinical examination No previous episode of psychosis No previous antipsychotics of any kind in last 3 months Exclusion Criteria: Have received a course of antipsychotics drug treatment prior to entry which may introduce risk factors or interfere with study procedures Have received anticholinergics within 10 days of baseline aseessment Have received mood stabilizers or anti depressants within 2 weeks
Sites / Locations
- Research Site
Outcomes
Primary Outcome Measures
The proportion of patients developing clinically significant EPS at any point between baseline (day 1) and final assessment
Secondary Outcome Measures
CGI severity of illness
CGI global improvement
PANSS total score and subscales)
Abnormal Involuntary Movement Scale (AIMS)
Dose of anti cholinergic medication
Serum prolactin levels
Proportion of patients discontinuing treatment due to reasons of lack of efficacy or adverse effects
Proportion of patients experiencing relapse.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00254241
Brief Title
Safety and Efficacy of Seroquel in First Episode Schizophrenia
Official Title
Safety and Efficacy of Seroquel in First Episode Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
To compare the safety, tolerability and efficacy of Seroquel and risperidone in first episode schizophrenia
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 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
80 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Seroquel and Risperidone
Primary Outcome Measure Information:
Title
The proportion of patients developing clinically significant EPS at any point between baseline (day 1) and final assessment
Secondary Outcome Measure Information:
Title
CGI severity of illness
Title
CGI global improvement
Title
PANSS total score and subscales)
Title
Abnormal Involuntary Movement Scale (AIMS)
Title
Dose of anti cholinergic medication
Title
Serum prolactin levels
Title
Proportion of patients discontinuing treatment due to reasons of lack of efficacy or adverse effects
Title
Proportion of patients experiencing relapse.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-35 years Meet ICD-10 criteria for schizophrenia No abnormaility on clinical examination No previous episode of psychosis No previous antipsychotics of any kind in last 3 months
Exclusion Criteria:
Have received a course of antipsychotics drug treatment prior to entry which may introduce risk factors or interfere with study procedures Have received anticholinergics within 10 days of baseline aseessment Have received mood stabilizers or anti depressants within 2 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Seroquel Medical Science Director, MD
Organizational Affiliation
AstraZenenca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
London
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Seroquel in First Episode Schizophrenia
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