Effect of Quetiapine on Negative Symptoms and Cognition

• Status: Completed
• Trial end date: 2003-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to investigate the outcome on negative symptoms of schizophrenic patients during therapy with quetiapine or risperidone.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Quetiapine Fumarate; Risperidone

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.