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

Primary Purpose

Schizophrenia, Schizoaffective Disorder, Hallucinations

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
functional magnetic resonance imaging
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring psychotic disorders, auditory hallucinations, brain structure, psychiatric disorder with auditory hallucinations (at least one every 20 minutes), schizophrenia/schizoaffective disorder without auditory hallucinations

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

1,2

Arm Description

Outcomes

Primary Outcome Measures

characterize abnormalities in brain structure and function related to schizophrenia

Secondary Outcome Measures

Full Information

First Posted
February 6, 2006
Last Updated
April 17, 2017
Sponsor
Vanderbilt University
Collaborators
National Alliance for Research on Schizophrenia and Depression
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1. Study Identification

Unique Protocol Identification Number
NCT00288340
Brief Title
Quantifying Abnormalities in Cortical Activation Associated With Auditory Hallucinations Using Functional Magnetic Resonance Imaging
Official Title
Quantifying Abnormalities in Cortical Activation Associated With Auditory Hallucinations Using Functional Magnetic Resonance Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vanderbilt University
Collaborators
National Alliance for Research on Schizophrenia and Depression

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder, Hallucinations
Keywords
psychotic disorders, auditory hallucinations, brain structure, psychiatric disorder with auditory hallucinations (at least one every 20 minutes), schizophrenia/schizoaffective disorder without auditory hallucinations

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1,2
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
functional magnetic resonance imaging
Primary Outcome Measure Information:
Title
characterize abnormalities in brain structure and function related to schizophrenia
Time Frame
two scans over a six month period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Anderson, Ph.D.
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States

12. IPD Sharing Statement

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

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