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Effect of Quetiapine on Negative Symptoms and Cognition

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ClinicalTrials.gov Identifier: NCT00305422
Recruitment Status : Completed
First Posted : March 22, 2006
Last Update Posted : June 11, 2009
Sponsor:
Information provided by:
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Quetiapine fumarate Drug: Risperidone Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy of Quetiapine Compared to Risperidone on Negative Symptoms and Cognition With Regard to Underlying Neurobiological Mechanisms and Brain Activation.
Study Start Date : November 2001
Actual Study Completion Date : January 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Clinical efficacy of both neuroleptics, especially with regard to cognitive deficits and functional brain activation between baseline and week 12

Secondary Outcome Measures :
  1. 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.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00305422


Locations
Germany
Research Site
Munich, Germany
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Germany Medical Director, MD AstraZeneca

ClinicalTrials.gov Identifier: NCT00305422     History of Changes
Other Study ID Numbers: 5077/9007
First Posted: March 22, 2006    Key Record Dates
Last Update Posted: June 11, 2009
Last Verified: June 2009

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Quetiapine Fumarate
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents