Schizophrenia
Conditions
Brief summary
The purpose of the study is to investigate the outcome on negative symptoms of schizophrenic patients during therapy with quetiapine or risperidone.
Interventions
DRUGQuetiapine fumarate
DRUGRisperidone
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical efficacy of both neuroleptics, especially with regard to cognitive deficits and functional brain activation between baseline and week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Outcome results
None listed