Back to resultsEffect of Quetiapine on Negative Symptoms and Cognition
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Quetiapine fumarate
Risperidone
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria: Signed informed consent men and women aged 18 to 65 years with diagnosis of schizophrenia score of at least 4 CGI, PANSS negative subscale score > 21 fulfil the criterion to be right-handed for inclusion in the fMRI investigations Exclusion Criteria: Substance or alcohol dependence female patients who are pregnant, lactating or at risk of pregnancy history of organic CNS-trauma, epilepsy, meningoencephalitis, psychosurgery, instable somatic conditions risk of suicide or aggressive behaviour history of electroconvulsive therapy, Parkinson's disease, Prolactin-dependent tumor For the subset of subjects for the fMRI investigations the following additional exclusion criteria is valid as: existence of metal in the body as by cardiac pacemaker, coil, total prosthesis, metal splinter, metal articulation, metal balls.
Sites / Locations
- Research Site
Outcomes
Primary Outcome Measures
Clinical efficacy of both neuroleptics, especially with regard to cognitive deficits and functional brain activation between baseline and week 12
Secondary Outcome Measures
Change from baseline in PANSS negative symptom total score, PANSS subscores, CGI, CGI-severity of illness, HAMD, Simpson-Angus-Scale, BPRS, specific PANSS items , Startle reflex.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00305422
Brief Title
Effect of Quetiapine on Negative Symptoms and Cognition
Official Title
Efficacy of Quetiapine Compared to Risperidone on Negative Symptoms and Cognition With Regard to Underlying Neurobiological Mechanisms and Brain Activation.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to investigate the outcome on negative symptoms of schizophrenic patients during therapy with quetiapine or risperidone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Quetiapine fumarate
Intervention Type
Drug
Intervention Name(s)
Risperidone
Primary Outcome Measure Information:
Title
Clinical efficacy of both neuroleptics, especially with regard to cognitive deficits and functional brain activation between baseline and week 12
Secondary Outcome Measure Information:
Title
Change from baseline in PANSS negative symptom total score, PANSS subscores, CGI, CGI-severity of illness, HAMD, Simpson-Angus-Scale, BPRS, specific PANSS items , Startle reflex.
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:
Signed informed consent
men and women aged 18 to 65 years with diagnosis of schizophrenia
score of at least 4 CGI, PANSS negative subscale score > 21
fulfil the criterion to be right-handed for inclusion in the fMRI investigations
Exclusion Criteria:
Substance or alcohol dependence
female patients who are pregnant, lactating or at risk of pregnancy
history of organic CNS-trauma, epilepsy, meningoencephalitis, psychosurgery, instable somatic conditions
risk of suicide or aggressive behaviour
history of electroconvulsive therapy, Parkinson's disease, Prolactin-dependent tumor
For the subset of subjects for the fMRI investigations the following additional exclusion criteria is valid as:
existence of metal in the body as by cardiac pacemaker, coil, total prosthesis, metal splinter, metal articulation, metal balls.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Germany Medical Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Munich
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Effect of Quetiapine on Negative Symptoms and Cognition
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