Effect of Quetiapine on Negative Symptoms and Cognition - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00305422

Purpose

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

Condition	Intervention	Phase
Schizophrenia	Drug: Quetiapine fumarate Drug: Risperidone	Phase IV

MedlinePlus related topics: Schizophrenia

Drug Information available for: Risperidone Quetiapine Quetiapine fumarate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Efficacy of Quetiapine Compared to Risperidone on Negative Symptoms and Cognition With Regard to Underlying Neurobiological Mechanisms and Brain Activation.

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.

Enrollment:	45
Study Start Date:	November 2001
Study Completion Date:	January 2003

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00305422

Locations

Germany
Research Site
Munich, Germany

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Germany Medical Director, MD

AstraZeneca

More Information

Study ID Numbers:	5077/9007
Study First Received:	March 20, 2006
Last Updated:	December 14, 2007
ClinicalTrials.gov Identifier:	NCT00305422
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Schizophrenia
Quetiapine
Dopamine
Mental Disorders

Risperidone
Psychotic Disorders
Serotonin
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists

Antipsychotic Agents
Pharmacologic Actions
Serotonin Antagonists
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009