NCT01399437

Brief Summary

Background: \- A special brain circuit is important for helping us keeping an eye open for things that are going on around us, even when we are not directly paying attention to them. This circuit seems to work differently in people with schizophrenia than in other people, which may explain specific deficits with broad monitoring observed in people with schizophrenia. Researchers want to compare brain function in people with schizophrenia and healthy volunteers to find out more about how these brain circuits work and affect attention. Objectives: \- To study how the brain performs broad visual monitoring in people with schizophrenia. Eligibility:

  • Individuals between 18 to 55 years of age who have been diagnosed with schizophrenia.
  • Healthy volunteers between 18 and 55. Design:
  • Participants will be screened with physical and psychological exams. They will have a medical history. Tests for drug and alcohol use will also be done.
  • Participants will have two study visits. The first is a training visit and the second is a scanning visit.
  • At the training visit, participants will practice computer-based tests of focus, memory, and concentration. They will also answer questions about mood, psychiatric symptoms, and smoking habits.
  • At the scanning visit, participants will perform the computer-based tasks that they practiced at the training visit. They will have magnetic resonance imaging while they perform these tasks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2011

Typical duration for all trials

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

July 3, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 21, 2011

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2014

Completed
Last Updated

April 5, 2018

Status Verified

December 24, 2014

First QC Date

July 20, 2011

Last Update Submit

April 4, 2018

Conditions

Keywords

Default NetworkSchizophreniafMRISpatial AttentionSentinel Function

Outcome Measures

Primary Outcomes (2)

  • Behavioral performance measures on the cognitive tasks (e.g. reaction time, accuracy)

  • Bold signal, specifically activation of the default network of resting brain function and its association with task performance.

Secondary Outcomes (1)

  • Secondary outcome measures include ratings and scores on questionnaires and characterization tools.

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All participants:
  • Age 18 through 55.
  • Normal or corrected to normal visual acuity (at least 20/80)
  • Participants with menat illness:
  • DSM-IV diagnosis of schizophrenia or schizoaffective disorder
  • Ability to give written informed consent
  • Four week of stable pharmacological treatment (same psychiatric medication at same dose or no medication)

You may not qualify if:

  • All participants:
  • Presence of ferromagnetic metal objects in the body, implanted electronic devices or any other counter -indication for MRI.
  • Claustrophobia
  • Left handed or ambidextrous
  • History of myocardial infarction or heart failur, which may cause asymptomatic brain lesions
  • Uncontrolled high blood pressure (resting systolic greater than 150 or diastolic greater than 90 mm Hg)
  • Neurological conditions likely to impair cognitive function such as stroke, seizures, dementia or organic brian syndrome
  • Any condition likely to impair cognitive function such as mental retardation or severe pharmacological sedation
  • Current use of vasodilating beta-blockers (carvedilol, labetalol or nebivolol)
  • Alcohol or substance abuse or dependence other than nicotine within the last 6 months
  • Pregnancy, verified by urin pregnancy test for females during screening and on the day of the scan.
  • Healthy Controls:
  • Current psychiatric Axis I disorder or Axis II schizophrenia spectrum disorder, verified by Structured Clinical Interview for DSM-IV (SCID)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maryland Psychiatric Research Center (MPRC) 55 Wade Avenue

Catonsville, Maryland, 21228, United States

Location

Related Publications (3)

  • Binder JR, Frost JA, Hammeke TA, Bellgowan PS, Rao SM, Cox RW. Conceptual processing during the conscious resting state. A functional MRI study. J Cogn Neurosci. 1999 Jan;11(1):80-95. doi: 10.1162/089892999563265.

    PMID: 9950716BACKGROUND
  • Buckner RL, Andrews-Hanna JR, Schacter DL. The brain's default network: anatomy, function, and relevance to disease. Ann N Y Acad Sci. 2008 Mar;1124:1-38. doi: 10.1196/annals.1440.011.

    PMID: 18400922BACKGROUND
  • Bustillo JR, Thaker G, Buchanan RW, Moran M, Kirkpatrick B, Carpenter WT Jr. Visual information-processing impairments in deficit and nondeficit schizophrenia. Am J Psychiatry. 1997 May;154(5):647-54. doi: 10.1176/ajp.154.5.647.

    PMID: 9137120BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Elliot Stein, Ph.D.

    National Institute on Drug Abuse (NIDA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
OTHER
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2011

First Posted

July 21, 2011

Study Start

July 3, 2011

Study Completion

December 24, 2014

Last Updated

April 5, 2018

Record last verified: 2014-12-24

Locations