In this study we intent to investigate changes in brain activation patterns using functional 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, a language and a motor task while laying in the scanner.We hypothesize that the efficiency of the working memory system is reduced and that lateralization of language is diminished in these patients, and that these functions will normalize after treatment.

Condition
Schizophrenia Schizophreniform Disorder Schizoaffective Disorder psychotic disorder Not Otherwise Specified

Further Study Details: 

Expected Total Enrollment:  30

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 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, 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.

Ages Eligible for Study:  16 Years   -   50 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria patients:

• Diagnoses of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS, confirmed on the basis of CASH or a SCID interview
• Age between 16 and 50 years
• CGI at least 4
• Patients are neuroleptive naive or medication-free for at least 2 weeks

Inclusion criteria healthy controls:

• no psychiatric disorder (according toDSM-IV, axis!)
• no psychiatric disorder in first degree relatives.
• age: 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 previous 3 months.
• pregnancy
• treatment with antidepressants or mood stabilizers within 3 weeks of inclusion.

Please refer to this study by ClinicalTrials.gov identifier  NCT00161057

Nicoletta v Veelen      +31 30 2508180    NvanVeelen@azu.nl

Netherlands
      Dept. of Psychiatry, UMC Utrecht, Utrecht,  3584 CX,  Netherlands; Recruiting

Study chairs or principal investigators

Nicoletta v Veelen,  Principal Investigator,  UMC Utrecht   
Rene Kahn, M.D. Ph.D.,  Study Chair,  UMC Utrecht   

Study ID Numbers:  METC 01/134
Last Updated:  September 11, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00161057
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
ClinicalTrials.gov processed this record on 2005-09-13