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fMRI Cholinergic Mechanisms in Schizophrenia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01191827
First Posted: August 31, 2010
Last Update Posted: May 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
This study aims to determine how clozapine treatment improves neuronal measures of sensory gating in subjects with schizophrenia.

Condition
Schizophrenia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: fMRI Cholinergic Mechanisms in Schizophrenia

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Neuronal Response During Sensory Gating [ Time Frame: Immediate ]
    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.


Enrollment: 40
Study Start Date: October 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
risperidone
clozapine
Patients with schizophrenia treated with clozapine

Detailed Description:
This study will use functional magnetic resonance imaging (fMRI) to study patients treated with risperidone, a commonly used neuroleptic that does not improves sensory gating, to those treated with clozapine to determine which brain areas are involved in clozapine's normalization of sensory gating in schizophrenia.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with schizophrenia
Criteria

Inclusion Criteria:

  • Diagnosis of schizophrenia
  • age 18-60 yrs

Exclusion Criteria:

  • claustrophobia
  • weight > 250 lbs
  • metal in body other than dental fillings
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01191827


Locations
United States, Colorado
VA Eastern Colorado Health Care System, Denver
Denver, Colorado, United States, 80220
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Jason R. Tregellas, PhD VA Eastern Colorado Health Care System, Denver
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01191827     History of Changes
Obsolete Identifiers: NCT00692679
Other Study ID Numbers: MHBB-011-07F
First Submitted: August 27, 2010
First Posted: August 31, 2010
Results First Submitted: December 23, 2014
Results First Posted: May 15, 2015
Last Update Posted: May 15, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs