Status:
COMPLETED
Effect of Quetiapine on Negative Symptoms and Cognition
Lead Sponsor:
AstraZeneca
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to investigate the outcome on negative symptoms of schizophrenic patients during therapy with quetiapine or risperidone.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2003
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00305422
Start Date
November 1 2001
End Date
January 1 2003
Last Update
June 11 2009
Active Locations (1)
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1
Research Site
Munich, Germany