Neural Oscillations as Genetic and Functional Biomarkers... | NCT01425671

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

NCT01425671

Sponsor

University of Maryland, Baltimore

Status

Completed

Last Update Posted

Apr 26, 2024Actual

Enrollment

800Estimated

Phase

Not provided

Conditions

Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorder

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01MH085646	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 30, 2010Actual

Primary Completion Date

Aug 2023Actual

Completion Date

Jan 2024Actual

First Submitted Date

Aug 28, 2011

First Submission Date that Met QC Criteria

Aug 29, 2011

First Posted Date

Aug 30, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2024

Last Update Posted Date

Apr 26, 2024Actual

Name	Class
National Institute of Mental Health (NIMH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

800Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Schizophrenic patients, family members		Schizophrenia Spectrum Disorder Patients
Controls		Normal controls

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	Time Frame
Symptom and Cognition rating		2 hrs

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

62 Years

Standard Ages

ChildAdult

Study Population

Schizophrenic patients, family members, controls

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
L.Elliot Hong, M.D.	Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maryland Psychiatric Research Center		Baltimore	Maryland	21228	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D012559	Schizophrenia
D011618	Psychotic Disorders

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders