Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effect of Quetiapine on Negative Symptoms and Cognition

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00305422
First received: March 20, 2006
Last updated: June 9, 2009
Last verified: June 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00305422     History of Changes
Other Study ID Numbers: 5077/9007
Study First Received: March 20, 2006
Last Updated: June 9, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Quetiapine
Risperidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 27, 2014