Microglia Activation in Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
UMC Utrecht
Information provided by:
VU University Medical Center
ClinicalTrials.gov Identifier:
NCT00205608
First received: September 13, 2005
Last updated: June 25, 2010
Last verified: July 2008
  Purpose

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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Microglia Activation in Schizophrenia: a Pilot Study

Resource links provided by NLM:


Further study details as provided by VU University Medical Center:

Primary Outcome Measures:
  • [11C]-(R)-Pk11195 binding [ Time Frame: within 5 years of start symptoms ] [ Designated as safety issue: No ]
    microglia activation in schizophrenia


Estimated Enrollment: 20
Study Start Date: January 2004
Study Completion Date: December 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Positron Emission Tomography
    camera is new
    Other Name: Siemens HR+
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Schizophrenia according to DSM-IV criteria confirmed by a diagnostic interview (CASH, only for patients) within the first 5 years after initial diagnosis
  • Male and Females
  • Good physical or mental (controls) Health which will be evaluated with medical history, a physical examination and screening laboratory tests (see appendix 1).
  • Age between 18 and 40 years (10 patients and 10 controls)
  • Mini Mental State score >27 .
  • Written informed consent of the subject.
  • Hb must be >8 mmol \ litre at the time of the screening.

Exclusion Criteria:

  • Previous neurotrauma with loss of consciousness
  • Any clinical significant abnormality of any clinical laboratory test, including drug screening.
  • Any subject who has received any investigational medication within 30 days prior to the start of this study, or who is scheduled to receive an investigational drug.

any other major current psychiatric diagnosis on axis-1 of DSM-IV (patients)

  • History of psychiatric or neurological illness (controls)
  • History of psychiatric or neurological illness in first-degree relatives (controls)
  • History of alcohol and/or drug abuse (DSM-IV criteria)
  • Blood donation within 3 months before the scan day
  • Claustrophobia
  • Metal objects in or around the body (braces, pacemaker, metal fragments); Pregnancy
  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: NCT00205608

Locations
Netherlands
VU University Medical Center
Amsterdam, Netherlands, 1081 HV
Sponsors and Collaborators
VU University Medical Center
UMC Utrecht
Investigators
Principal Investigator: Bart van Berckel, MD; PhD UMC Utrecht
  More Information

No publications provided

Responsible Party: B.N.M. van Berckel, VU Medical Center
ClinicalTrials.gov Identifier: NCT00205608     History of Changes
Other Study ID Numbers: 2002/194
Study First Received: September 13, 2005
Last Updated: June 25, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by VU University Medical Center:
schizophrenia
microglia
PET

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014