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

NCT ID: NCT00288340

Last Updated: 2017-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2006-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Schizophrenia Schizoaffective Disorder Hallucinations

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1,2

Group Type ACTIVE_COMPARATOR

functional magnetic resonance imaging

Intervention Type DEVICE

Interventions

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functional magnetic resonance imaging

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Alliance for Research on Schizophrenia and Depression

OTHER

Sponsor Role collaborator

Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adam Anderson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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NARSAD

Identifier Type: -

Identifier Source: secondary_id

050978

Identifier Type: -

Identifier Source: org_study_id

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