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

NCT ID: NCT01425671

Last Updated: 2024-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2024-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Schizophrenia Schizoaffective Disorder Schizophreniform Disorder

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Schizophrenic patients, family members

Schizophrenia Spectrum Disorder Patients

No interventions assigned to this group

Controls

Normal controls

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

62 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role lead

Responsible Party

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L. Elliot Hong

L. Elliot Hong

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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L.Elliot Hong, M.D.

Role: PRINCIPAL_INVESTIGATOR

Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine

Locations

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Maryland Psychiatric Research Center

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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R01MH085646

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HP-00043082

Identifier Type: -

Identifier Source: org_study_id

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