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

This study has been completed.
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00288340
First received: February 6, 2006
Last updated: August 12, 2008
Last verified: August 2008
History of Changes
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Adam Anderson, Ph.D., Vanderbilt Medical Center
ClinicalTrials.gov Identifier: NCT00288340     History of Changes
Other Study ID Numbers: 050978, NARSAD
Study First Received: February 6, 2006
Last Updated: August 12, 2008
Health Authority: United States: Institutional Review Board

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:
Congenital Abnormalities
Hallucinations
Psychotic Disorders
Schizophrenia
Perceptual Disorders
Neurobehavioral Manifestations
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013