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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder

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.

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21228
      • Maryland Psychiatric Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 62 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Schizophrenic patients, family members, controls

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Schizophrenic patients, family members; Schizophrenia Spectrum Disorder Patients
Controls; Normal controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	10-12 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Symptom and Cognition rating	2 hrs

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2010
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: August 28, 2011
• First Submitted That Met QC Criteria: August 29, 2011
• First Posted (Estimated): August 30, 2011

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Schizophrenia; Family; Psychosis
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders
• Other Study ID Numbers: HP-00043082; R01MH085646 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No