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Quantifying Abnormalities in Cortical Activation Associated With Auditory Hallucinations Using Functional Magnetic Resonance Imaging

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00288340
First Posted: February 7, 2006
Last Update Posted: April 19, 2017
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.
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Vanderbilt University
  Purpose
The goal of the project is to characterize abnormalities in brain structure and function related to schizophrenia. The investigators will use advanced magnetic resonance imaging (MRI) techniques to measure the degree and distribution of neuronal activity during specific cognitive tasks, alterations in neuronal connectivity, and how these are related to disease symptoms and treatment.

Condition Intervention
Schizophrenia Schizoaffective Disorder Hallucinations Device: functional magnetic resonance imaging

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Quantifying Abnormalities in Cortical Activation Associated With Auditory Hallucinations Using Functional Magnetic Resonance Imaging

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • characterize abnormalities in brain structure and function related to schizophrenia [ Time Frame: two scans over a six month period ]

Estimated Enrollment: 60
Study Start Date: January 2006
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1,2 Device: functional magnetic resonance imaging

Detailed Description:

The goal of the project is to characterize abnormalities in brain structure and function related to schizophrenia. We will use advanced magnetic resonance imaging (MRI) techniques to measure the degree and distribution of neuronal activity during specific cognitive tasks, alterations in neuronal connectivity, and how these are related to disease symptoms and treatment. We will focus on changes in brain structure and function associated with frequent auditory hallucinations, one of the most disabling manifestations of schizophrenia, and with neuroleptic treatment. In order to address these aims, we will study four groups of subjects:

  1. patients who have frequent auditory hallucinations,
  2. patients who are beginning a regimen of anti-psychotic medication,
  3. patients who do not have frequent hallucinations and are not changing medication strategies, and
  4. age-matched normal controls. Each group will contain 15 subjects for a total of 60.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Investigators will study subjects who:

  • Are between the ages of 18 and 65.
  • Meet diagnostic criteria for any psychiatric disorder with auditory hallucinations (at least one every 20 minutes) including schizophrenia/schizoaffective disorder OR schizophrenia/schizoaffective disorder without auditory hallucinations.
  • Have been treated with an antipsychotic drug for hallucinations at least three months or are unmedicated
  • Are willing to change their current antipsychotic medication if indicated
  • Are able to provide written consent

Normal controls must :

  • Be between the ages of 18 and 65
  • Not meet the diagnostic criteria for schizophrenia or schizoaffective disorder or other psychiatric disorder involving hallucinations
  • Not currently be treated with an antipsychotic drug
  • Be able to provide written consent

Exclusion Criteria:

Subjects and normal controls will be excluded from participation if there is:

  • Evidence of non-psychiatric, chronic central nervous system (CNS) disease (such as brain injury or neurological disease)
  • Contraindication to MRI, including prior claustrophobic reaction and severe movement disorder
  • A recent change in menstrual status other than recent changes in oral or implanted contraceptive use (for females)
  • A positive pregnancy result (for females)
  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): NCT00288340


Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University
National Alliance for Research on Schizophrenia and Depression
Investigators
Principal Investigator: Adam Anderson, Ph.D. Vanderbilt University Medical Center
  More Information

Responsible Party: Vanderbilt University
ClinicalTrials.gov Identifier: NCT00288340     History of Changes
Other Study ID Numbers: 050978
NARSAD
First Submitted: February 6, 2006
First Posted: February 7, 2006
Last Update Posted: April 19, 2017
Last Verified: April 2017

Keywords provided by Vanderbilt University:
psychotic disorders
auditory hallucinations
brain structure
psychiatric disorder with auditory hallucinations (at least one every 20 minutes)
schizophrenia/schizoaffective disorder without auditory hallucinations

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Hallucinations
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms