Effect of Quetiapine on Negative Symptoms and Cognition

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Quetiapine fumarate; Drug: Risperidone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00305422

5077/9007

Details and patient eligibility

About

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

Enrollment: 45 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind