SchizophreniaNCT03092687
Procedures for Sample Acquisition and Distribution for The Human Brain Collection Core
An observational study of Schizophrenia and Major Depression, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 120 years
- Conditions the study is for
- Schizophrenia, Major Depression, Bipolar Disorder
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2017to 29 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Community Samples
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Mental Health (NIMH)
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Schizophrenia, Major Depression, Bipolar Disorder, PTSD
- Keywords
- Mental Illness, Aging, Normal Development
- Medical subject headings
- Schizophrenia, Depressive Disorder, Major, Bipolar Disorder, Stress Disorders, Post-Traumatic, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| psychiatric disorders | decedents with and without psychiatric use disorders | |
| substance disorders | decedents with and without substance use disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
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...
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start21 Mar 2017
- Primary completion29 Aug 2019
- Study completion29 Aug 2019
Why it stopped: Not considered to be human subjects research
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Stefano Marenco, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03092687
- Sponsor's protocol ID
- 999917073
- Other IDs
- 17-M-N073
- Status last verified
- Aug 2019
- First submitted
- 23 Mar 2017
- Last updated
- 6 Sep 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procedures for Sample Acquisition and Distribution for The Human Brain Collection Core
- ClinicalTrials.gov ID
- NCT03092687
- Acronym / sponsor ID
- 999917073
- Conditions
- Schizophrenia, Major Depression, Bipolar Disorder, PTSD
- Keywords
- Mental Illness, Aging, Normal Development
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Not considered to be human subjects research
- Enrolment
- 192 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 21 Mar 2017 (actual)
- Primary completion
- 29 Aug 2019 (actual)
- Study completion
- 29 Aug 2019 (actual)
- First posted
- 28 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| psychiatric disorders | – | –decedents with and without psychiatric use disorders |
| substance disorders | – | –decedents with and without substance use disorders |
Who may qualify
- Ages
- Up to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Community Samples
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study was stopped early (reason given: Not considered to be human subjects research). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Marenco, M.D. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Major Depression, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Not considered to be human subjects research). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.