Procedures for Sample Acquisition and Distribution for The Human Brain Collection Core

NCT03092687 | Terminated

• 2 other identifiers: 99991707317-M-N073
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The Human Brain Collection Core (HBCC) collects brain and other tissues. They get these from deceased people who may or may not have had psychiatric disorders. The next of kin gives permission for researchers to get the tissues. Researchers want to collect medical details of people whose brains are donated. They also want to use the donated tissue to study brain chemistry and structure. This could lead to better treatments for mental illness. Objective: To create a collection of human brain tissue to learn about the causes and mechanisms of mental disorders. Eligibility: People willing to donate their deceased relative s brain tissue. The deceased person could not have had any of the following: Severe mental retardation Long-lasting seizure disorder Infections that affect the brain Decomposition Brain damage Being on a respirator for more than 12 hours Major sepsis Serious renal or hepatic disease Certain dementias and degenerative diseases Design: Medical Examiner s Offices will screen donors who have recently died. Some others will be screened by hospitals or funeral homes. Participants will be the next of kin. They will give consent for HBCC to obtain brain tissue from the deceased person. The tissue will be frozen for future research. Participants will have a 30-minute phone call. They will answer questions about the deceased person s medical and psychiatric conditions. They will answer questions about the person s use of medicines and drugs. Participants will be contacted by a social worker. They will be asked for permission to access the deceased person s medical records.

Conditions

Schizophrenia; Major Depression; Bipolar Disorder; PTSD

Keywords

Mental Illness; Aging; Normal Development

Outcome Measures

Primary Outcomes (1)

• To accumulate a vast repository of human brain tissues and characterize molecular signatures of psychiatric disorders using techniques such as genome-wide association analyses, DNA methylation, acetylation and chromatin modification patterns, RN...

  ongoing

Study Arms (2)

psychiatric disorders

decedents with and without psychiatric use disorders

substance disorders

decedents with and without substance use disorders

Eligibility Criteria

• Age: Up to 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community Samples

You may qualify if:

• Brain tissue is needed from individuals suffering from a variety of neuropsychiatric disorders, including schizophrenia, anxiety disorders, suicide, bipolar disorder, depression, and substance use disorders (cocaine, alcohol, heroin or the like). In addition, brains from individuals without a history of neuropsychiatric disease will be needed as controls.

You may not qualify if:

• An assessment is carried out on the information available from the referral source (generally a Medical Examiner s Office) prior to obtaining consent. This information is usually very succinct, indicating how the decedent was found and, if known, whether they had some psychiatric or obvious medical history. The following cases will be
• excluded from collection:
• Severe mental retardation.
• Well documented, long lasting seizure disorder.
• Infections known to affect the brain such as syphilis, tuberculosis, with the exception of HIV infection.
• The body is decomposed. We consider collecting the brain up to three days after death.
• There is obvious damage to the brain by closed head injury or other trauma (gunshot wound, fall, etc.).
• There are brain infarcts, hemorrhages, tumors, stroke, or other brain lesions that destroy the normal brain structure.
• The patient has been maintained on a respirator (ventilator) for more than 12 hours in the period immediately prior to death.
• Major sepsis.
• Serious renal or hepatic disease.
• Multiple sclerosis (MS), Alzheimer s disease and other dementias and degenerative diseases.
• Known infection with Hepatitis C

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institute of Mental Health (NIMH)

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Schizophrenia; Depressive Disorder, Major; Bipolar Disorder; Stress Disorders, Post-Traumatic; Mental Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Depressive Disorder; Mood Disorders; Bipolar and Related Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Stefano Marenco, M.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: March 28, 2017
• Study Start: March 21, 2017
• Primary Completion: August 29, 2019
• Study Completion: August 29, 2019
• Last Updated: September 6, 2019

Record last verified: 2019-08

Locations

US (1)