Microglia Activation in Schizophrenia
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 schizophrenia
Started Jan 2004
Longer than P75 for phase_1 schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedJune 28, 2010
July 1, 2008
3.2 years
September 13, 2005
June 25, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
[11C]-(R)-Pk11195 binding
microglia activation in schizophrenia
within 5 years of start symptoms
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amsterdam UMC, location VUmclead
- UMC Utrechtcollaborator
Study Sites (1)
VU University Medical Center
Amsterdam, Amsterdam, 1081 HV, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bart van Berckel, MD; PhD
UMC Utrecht
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 20, 2005
Study Start
January 1, 2004
Primary Completion
March 1, 2007
Study Completion
December 1, 2007
Last Updated
June 28, 2010
Record last verified: 2008-07