Procedures for Sample Acquisition and Distribution for The Human Brain Collection Core
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03092687|
Recruitment Status : Recruiting
First Posted : March 28, 2017
Last Update Posted : May 25, 2018
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.
To create a collection of human brain tissue to learn about the causes and mechanisms of mental disorders.
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
Being on a respirator for more than 12 hours
Serious renal or hepatic disease
Certain dementias and degenerative diseases
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.
|Condition or disease|
|Schizophrenia Major Depression Bipolar Disorder PTSD|
Objective: The mission of Human Brain Collection Core (HBCC) is to gain insight into the causes and mechanisms of mental disorders.
Study Population: To be able to conduct this research, we obtain brain and other tissues from deceased individuals with and without psychiatric disorders.
Study Design: This protocol provides the ethical and scientific framework for tissue donations through referrals from Offices of the Chief Medical Examiners, hospitals or funeral homes. The next of kin are contacted to give permission for brain donation from the deceased. Once the tissue is obtained, it is frozen, catalogued and processed for distribution to other researchers and for in-house analysis. The HBCC dissects specific brain tissues based on request. All collaborations are subject to approval by an oversight committee. Currently, HBCC can leverage over 1,000 brains from a variety of psychiatric disorders and non-psychiatric subjects.
Outcome measures: Outcomes vary with specific collaborations, but include characterization of DNA, RNA, protein and other brain constituents that provide unique information at the molecular level. The data thus obtained are expected to provide new insights into brain physiology and the molecular pathology of psychiatric disorders, possibly leading to the identification of new therapeutic targets.
|Study Type :||Observational|
|Estimated Enrollment :||2500 participants|
|Official Title:||Procedures for Sample Acquisition and Distribution for The Human Brain Collection Core|
|Estimated Study Start Date :||May 30, 2018|
|Estimated Primary Completion Date :||January 1, 2040|
|Estimated Study Completion Date :||December 31, 2040|
decedents with and without psychiatric use disorders
decedents with and without substance use disorders
- 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... [ Time Frame: ongoing ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03092687
|Contact: Stefano Marenco, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institute of Mental Health (NIMH)||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Stefano Marenco, M.D.||National Institute of Mental Health (NIMH)|