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Sponsored by: |
VU University Medical Center |
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Information provided by: | VU University Medical Center |
ClinicalTrials.gov Identifier: | NCT00205608 |
Patients with schizophrenia have volume loss in gray matter. This study is designed to evaluate whether their is microglia activation in schizophrenia using [11C](R)-PK11195 PET.
Condition | Intervention | Phase |
---|---|---|
Schizophrenia |
Device: Positron Emission Tomography |
Phase I |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | Microglia Activation in Schizophrenia: a Pilot Study |
Estimated Enrollment: | 20 |
Study Start Date: | January 2004 |
Estimated Study Completion Date: | December 2006 |
Schizophrenia is a complex and chronic disease that affects different aspects of cognition and behaviour, including attention, perception, thought processes, emotion and volition. Schizophrenia is a brain disease particularly involving decrement in gray matter as has been supported by findings from many imaging studies. The pathophysiology of these gray matter changes has not been clarified. Microglia activation is the consequence of virtually all conditions associated with neuronal injury. When activated following neuronal damage, microglia show a marked increase in the expression of peripheral type benzodiazepine binding sites which are particularly abundant on cells of the mononuclear macrophage.
(R)-PK11195 [1-(2-chlorophenyl)-N-methyl-N-1(1-methylpropyl]-3 isoquinolinecarboxamide) is a highly selective ligand for the peripheral benzodiazepine binding site. (R)-PK11195, labelled with the positron emitter carbon-11, can be used to monitor the peripheral type benzodiazepine receptors using Positron Emission Tomography (PET). At the Vrije Universiteit Medical Centre (R)-[11C]PK11195 is used for studying microglia activation in-vivo in patients with traumatic brain damage, minimal cognitive impairment and Alzheimer disease.
The objective of this study is to determine whether and to what extent microglia activation occurs in schizophrenia. Ten patients with schizophrenia will be recruited and 10 controls, matched for age and gender. This is an open study. The study consists of one PET scan, which will be performed at the Clinical PET Centre of the Vrije Universiteit Medical Centre. All subjects will also get a MRI scan, which will be performed at the department of Radiology, University Medical Centre Utrecht.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
any other major current psychiatric diagnosis on axis-1 of DSM-IV (patients)
Contact: Bart van Berckel, MD; PhD | ++31204444214 | B.Berckel@VUmc.nl |
Netherlands | |
VU University Medical Center | Recruiting |
Amsterdam, Netherlands, 1081 HV | |
Contact: Bart van Berckel, MD, PhD ++31204444212 B.Berckel@VUmc.nl |
Principal Investigator: | Bart van Berckel, MD; PhD | University Medical Center Utrecht |
Study ID Numbers: | 2002/194 |
Study First Received: | September 13, 2005 |
Last Updated: | September 7, 2006 |
ClinicalTrials.gov Identifier: | NCT00205608 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
schizophrenia microglia PET |
Schizophrenia Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |