Neural Oscillations as Genetic and Functional Biomarkers in Normal and Disease States

This study is currently recruiting participants.
Verified March 2012 by University of Maryland
Sponsor:
Collaborator:
Information provided by (Responsible Party):
MPRC, University of Maryland
ClinicalTrials.gov Identifier:
NCT01425671
First received: August 28, 2011
Last updated: March 19, 2012
Last verified: March 2012

August 28, 2011
March 19, 2012
January 2011
January 2020   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT01425671 on ClinicalTrials.gov Archive Site
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Not Provided
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Neural Oscillations as Genetic and Functional Biomarkers in Normal and Disease States
Neural Oscillations as Genetic and Functional Biomarkers in Normal and Disease States

The principle aim of the project is to analyze brain electrical activity and genetic information that will help identify the nature and cause of the disease schizophrenia. This effort should lay the groundwork for future treatment in schizophrenic patients.

There are several studies and hypotheses to be tested. This project includes a cross-sectional study design measuring brain waves, clinical symptoms, cognitive and functional ability, and genetic information in schizophrenic patients and normal controls. Subjects are expected to do a brain wave recording (EEG/ERP), role-play test designed to measure functionality and cognitive ability, and clinical symptom assessments. Expected duration of subject participation will be approximately 8 hours (about 2 visits). Outcome measures includes biomarkers, clinical symptoms and function, and genetic information.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

Blood sample

Probability Sample

Schizophrenic patients, family members, controls

  • Schizophrenia
  • Schizoaffective Disorder
  • Schizophreniform Disorder
Not Provided
  • Schizophrenic patients, family members
  • Controls
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
800
January 2020
January 2020   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and Female between ages 14-62 (clinical assessment and blood draw only above 62)
  • Ability to give written assent (subjects who are below the age of 18)
  • Ability to give written informed consent (age 18 or above)
  • Sufficient understanding of the study and risks (ESC score 10 or above)
  • Subjects above age 62 will not participate in brain electrical activity measurements although they may still participate in clinical assessments and blood draw.

Exclusion Criteria:

  • Inability to sign informed consent/assent
  • Any major medical illness that may affect normal brain functioning. Examples of these conditions include, but not limited to, stroke, repeated seizure, history of significant head trauma, CNS infection or tumor, an other significant brain neurological conditions.
  • Significant alcohol or drug use (substance dependence within 6 months or substance abuse within 1 month) other than nicotine or marijuana dependence.
  • Woman who is pregnant (child bearing potential but not on contraceptive and missing menstrual period; or by self-report; or by positive pregnancy test).
  • Can not refrain from using alcohol and/or marijuana 24 hours or more& cigarette smoking half and hour or more prior to experiments.
Both
14 Years to 62 Years
Yes
Not Provided
United States
 
NCT01425671
HP-00043082, MH85646
No
MPRC, University of Maryland
University of Maryland
National Institutes of Health (NIH)
Principal Investigator: L.Elliot Hong, M.D. Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine
University of Maryland
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP