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Functional Brain Activation Patterns in Schizophrenia, Measured Before and After Treatment
This study is currently recruiting participants.
Verified by UMC Utrecht, September 2005
Sponsored by: UMC Utrecht
Information provided by: UMC Utrecht
ClinicalTrials.gov Identifier: NCT00161057
  Purpose

In this study we, the investigators at UMC Utrecht, intend to investigate changes in brain activation patterns using functional magnetic resonance imaging (MRI), in patients suffering from schizophrenia who are medication naive or off medication, before using medication and after 8 weeks of medication. Patients will perform a working memory task, a language task and a motor task while lying in the scanner. We hypothesize that the efficiency of the working memory system is reduced and that the lateralization of language is diminished in these patients, and that these functions will normalize after treatment.


Condition
Schizophrenia
Schizophreniform Disorders

MedlinePlus related topics: Memory Psychotic Disorders Schizophrenia
U.S. FDA Resources
Study Type: Observational
Study Design: Natural History, Cross-Sectional, Defined Population, Prospective Study
Official Title: Functional Brain Activation Patterns in Schizophrenia, Measured Before and After Treatment

Further study details as provided by UMC Utrecht:

Estimated Enrollment: 30
Study Start Date: December 2001
Estimated Study Completion Date: September 2006
Detailed Description:

Schizophrenia is a heterogeneous disorder with a wide range of symptoms and signs including hallucinations, delusions, disorganisation, negative symptoms and cognitive deficits. Investigation of the neural substrates of the cognitive deficits in schizophrenia has revealed abnormalities in brain activity patterns. Particularly, earlier studies using functional FMRI conducted at the UMCU, revealed diminished language laterality, deficits in working memory and a reduced ability to automate cognitive processes. The aim of this project is to study the relationship between these brain activation patterns and neuroleptic treatment. More insight into psychopharmacological effects on brain physiology, may eventually enable us to better predict what effect treatment will have on patients.

Patients with a confirmed diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder not otherwise specified (NOS), who are medication naive or medication free for a period of at least 2 weeks will be included. Patients will be tested before and after 8 weeks of treatment with an atypical antipsychotic. In the scanner patients will perform a working memory task, a language task and a visual-motor task. At study entry and after 8 weeks the PANSS, Clinical Global Impressions (CGI) and CDSS (Calgary Depression Scale of Schizophrenia) will be performed. Besides these patients, we will also include a group of matched healthy controls. We hypothesize that in medication naive or patients of-medication lateralization is reduced, and that efficiency of the working memory system is reduced. Lateralization is expected to correlate negatively with positive functions. We expect that antipsychotic treatment will normalize brain function and that the degree of normalization is correlated with the clinical measures of treatment efficacy.

  Eligibility

Ages Eligible for Study:   16 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria (patients):

  • Diagnoses of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS, confirmed on the basis of Comprehensive Assessment of Symptoms and History (CASH) or a Structured Clinical Interview for DSM-IV Disorders (SCID) interview
  • Ages between 16 and 50 years
  • CGI of at least 4
  • Patients are neuroleptic-naive or medication-free for at least 2 weeks

Inclusion Criteria (healthy controls):

  • No psychiatric disorders (according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition [DSM-IV], Axis I)
  • No psychiatric disorders in first degree relatives.
  • Ages: between 18 and 50 years old

Exclusion Criteria (patients and healthy controls):

  • Ferrous objects in or around the body
  • Neurological or medical illness, including closed head injury.
  • Mental retardation.
  • Diagnosis of substance dependence within the previous 3 months.
  • Pregnancy
  • Treatment with antidepressants or mood stabilizers within 3 weeks of inclusion.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00161057

Contacts
Contact: Nicoletta V Veelen +31 30 2508180 NvanVeelen@azu.nl

Locations
Netherlands
Dept. of Psychiatry, UMC Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Contact: Nicoletta V Veelen, M.D.     +31 30 2508180     NvanVeelen@azu.nl    
Principal Investigator: Nicoletta V Veelen, M.D.            
Sponsors and Collaborators
UMC Utrecht
Investigators
Principal Investigator: Nicoletta V Veelen UMC Utrecht
Study Chair: Rene Kahn, M.D. Ph.D. UMC Utrecht
  More Information

Study ID Numbers: METC 01/134
Study First Received: September 8, 2005
Last Updated: September 7, 2006
ClinicalTrials.gov Identifier: NCT00161057  
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:
Schizophrenia
Medication-naive
Functional MRI
Working memory
Language lateralization
schizoaffective disorder
psychotic disorder Not Otherwise Specified

Study placed in the following topic categories:
Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on January 16, 2009