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Completed

NCT Number: NCT00288340

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

About this study

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:

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Functional Magnetic Resonance Imaging

Device

Primary outcomes

  1. characterize abnormalities in brain structure and function related to schizophrenia

    Time frame: two scans over a six month period

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • National Alliance for Research on Schizophrenia and Depression

Registry information

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Feb 7, 2006
Registry last updated
Apr 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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