fMRI Cholinergic Mechanisms in Schizophrenia
1 other identifier
observational
40
1 country
1
Brief Summary
This study aims to determine how clozapine treatment improves neuronal measures of sensory gating in subjects with schizophrenia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2008
Typical duration for all trials
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
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 27, 2010
CompletedFirst Posted
Study publicly available on registry
August 31, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
May 15, 2015
CompletedMay 15, 2015
May 1, 2015
3.2 years
August 27, 2010
December 23, 2014
May 12, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Neuronal Response During Sensory Gating
Neuronal response (blood oxygenation level dependent functional magnetic resonance imaging signal, relative to the global mean) during sensory gating. Sensory gating is defined as the process of filtering out unnecessary environmental stimuli.
Immediate
Study Arms (2)
risperidone
clozapine
Patients with schizophrenia treated with clozapine
Eligibility Criteria
Subjects with schizophrenia
You may qualify if:
- Diagnosis of schizophrenia
- age 18-60 yrs
You may not qualify if:
- claustrophobia
- weight \> 250 lbs
- metal in body other than dental fillings
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Eastern Colorado Health Care System, Denver
Denver, Colorado, 80220, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Research Biologist
- Organization
- Denver VA Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Jason R. Tregellas, PhD
VA Eastern Colorado Health Care System, Denver
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2010
First Posted
August 31, 2010
Study Start
October 1, 2008
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
May 15, 2015
Results First Posted
May 15, 2015
Record last verified: 2015-05