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

NCT01425671 | Completed

• 2 other identifiers: HP-00043082R01MH085646
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder

Keywords

Schizophrenia; Family; Psychosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Symptom and Cognition rating

  2 hrs

Study Arms (2)

Schizophrenic patients, family members

Schizophrenia Spectrum Disorder Patients

Controls

Normal controls

Eligibility Criteria

• Age: 14 Years - 62 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Schizophrenic patients, family members, controls

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Maryland Psychiatric Research Center

Baltimore, Maryland, 21228, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• L.Elliot Hong, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: L. Elliot Hong

Study Record Dates

• First Submitted: August 28, 2011
• First Posted: August 30, 2011
• Study Start: November 30, 2010
• Primary Completion: August 1, 2023
• Study Completion: January 1, 2024
• Last Updated: April 26, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)