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Sponsored by: |
UMC Utrecht |
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Information provided by: | UMC Utrecht |
ClinicalTrials.gov Identifier: | NCT00161057 |
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 |
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Schizophrenia Schizophreniform Disorders |
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 |
Estimated Enrollment: | 30 |
Study Start Date: | December 2001 |
Estimated Study Completion Date: | September 2006 |
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.
Ages Eligible for Study: | 16 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria (patients):
Inclusion Criteria (healthy controls):
Exclusion Criteria (patients and healthy controls):
Contact: Nicoletta V Veelen | +31 30 2508180 | NvanVeelen@azu.nl |
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. |
Principal Investigator: | Nicoletta V Veelen | UMC Utrecht |
Study Chair: | Rene Kahn, M.D. Ph.D. | UMC Utrecht |
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) |
Schizophrenia Medication-naive Functional MRI Working memory |
Language lateralization schizoaffective disorder psychotic disorder Not Otherwise Specified |
Schizophrenia Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |