NCT00288340

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Jan 2006

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 7, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

April 19, 2017

Status Verified

April 1, 2017

Enrollment Period

7 months

First QC Date

February 6, 2006

Last Update Submit

April 17, 2017

Conditions

Keywords

psychotic disordersauditory hallucinationsbrain structurepsychiatric disorder with auditory hallucinations (at least one every 20 minutes)schizophrenia/schizoaffective disorder without auditory hallucinations

Outcome Measures

Primary Outcomes (1)

  • characterize abnormalities in brain structure and function related to schizophrenia

    two scans over a six month period

Study Arms (1)

1,2

ACTIVE COMPARATOR
Device: functional magnetic resonance imaging

Interventions

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersHallucinations

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Adam Anderson, Ph.D.

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2006

First Posted

February 7, 2006

Study Start

January 1, 2006

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

April 19, 2017

Record last verified: 2017-04

Locations