Effect of Quetiapine on Negative Symptoms and Cognition

AstraZeneca45 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Schizophrenia

Interventions

Quetiapine fumarateDRUG

RisperidoneDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Research Site

Munich, Germany

Outcomes

Primary Outcomes

Clinical efficacy of both neuroleptics, especially with regard to cognitive deficits and functional brain activation between baseline and week 12

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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