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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00288340
• Other study ID #: 050978
• Secondary ID: NARSAD
• Status: Completed
• Phase: N/A
• First received: February 6, 2006
• Last updated: April 17, 2017
• Start date: January 2006
• Est. completion date: August 2006

Study information

• Verified date: April 2017
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hallucinations
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Device:
• functional magnetic resonance imaging

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	National Alliance for Research on Schizophrenia and Depression

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	characterize abnormalities in brain structure and function related to schizophrenia		two scans over a six month period