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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:
National Institutes of Health (NIH)
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
History of Changes
  Purpose

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.


Condition
Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorder

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Neural Oscillations as Genetic and Functional Biomarkers in Normal and Disease States

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Maryland:

Biospecimen Retention:   Samples With DNA

Blood sample


Estimated Enrollment: 800
Study Start Date: January 2011
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
Schizophrenic patients, family members
Controls

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   14 Years to 62 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Schizophrenic patients, family members, controls

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01425671

Locations
United States, Maryland
Maryland Psychiatric Research Center Recruiting
Baltimore, Maryland, United States, 21228
Contact: Kavita Thangavelu, MSW     410-402-6124     Kthangavelu@mprc.umaryland.edu    
Sponsors and Collaborators
University of Maryland
National Institutes of Health (NIH)
Investigators
Principal Investigator: L.Elliot Hong, M.D. Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine
  More Information

No publications provided

Responsible Party: MPRC, L. Elliot Hong, University of Maryland
ClinicalTrials.gov Identifier: NCT01425671     History of Changes
Other Study ID Numbers: HP-00043082, MH85646
Study First Received: August 28, 2011
Last Updated: March 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
Schizophrenia
Family
Psychosis

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013