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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01425671
• Other study ID #: HP-00043082
• Secondary ID: R01MH085646
• Status: Completed
• Start date: November 30, 2010
• Est. completion date: January 2024

Study information

• Verified date: November 2023
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: January 2024
• Est. primary completion date: August 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 62 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Schizophreniform Disorder

Locations

Country	Name	City	State
United States	Maryland Psychiatric Research Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Symptom and Cognition rating		2 hrs