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

This study is currently recruiting participants.
Verified March 2017 by MPRC, University of Maryland
Sponsor:
ClinicalTrials.gov Identifier:
NCT01425671
First Posted: August 30, 2011
Last Update Posted: March 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
MPRC, University of Maryland
  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:


Further study details as provided by MPRC, University of Maryland:

Primary Outcome Measures:
  • We will measure oscillatory abnormalities in resting, sensory response to single sound (SS), response to steady state auditory evoked potential , to a continuous matching task , and response during encoding and retrieval during a sensory retention task. [ Time Frame: 10-12 hours ]

Secondary Outcome Measures:
  • Symptom and Cognition rating [ Time Frame: 2 hrs ]

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
Schizophrenia Spectrum Disorder Patients
Controls
Normal 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

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 62 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01425671


Locations
United States, Maryland
Maryland Psychiatric Research Center Recruiting
Baltimore, Maryland, United States, 21228
Contact: Caroline Silva, MSW    410-402-6126    csilva@mprc.umaryland.edu   
Contact: Dawn Detamore    410-402-6820    ddetamor@mprc.umaryland.edu   
Sponsors and Collaborators
University of Maryland
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: L.Elliot Hong, M.D. Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine
  More Information

Responsible Party: MPRC, L. Elliot Hong, University of Maryland
ClinicalTrials.gov Identifier: NCT01425671     History of Changes
Other Study ID Numbers: HP-00043082
R01MH085646 ( U.S. NIH Grant/Contract )
First Submitted: August 28, 2011
First Posted: August 30, 2011
Last Update Posted: March 17, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by MPRC, University of Maryland:
Schizophrenia
Family
Psychosis

Additional relevant MeSH terms:
Disease
Schizophrenia
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders