Bipolar DisorderNCT00001260
Brain Tissue Collection for Neuropathological Studies
An observational study of Bipolar Disorder and Depression, run by National Institute of Mental Health (NIMH) at 3 sites in United States.
Trial summary
The purpose of this study is to collect and study the brain tissue of deceased individuals to learn more about the nervous system and mental disorders. Information gained from donated tissue may lead to better treatments and potential cures for nervous system and mental disorders. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder, Depression, Anxiety Disorders
- How many people
- 2,161 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 May 1990to 16 Jun 2017
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Brain tissue is needed from individuals suffering from a variety of neuropsychiatric disorders, especially schizophrenia, but also anxiety disorders, suicide, bipolar disorder, depression, Tourette's Syndrome, drug addictions (PCP, cocaine, alcohol, heroin or the like) and any form of dementia. In addition, brains from normal individuals without a history of neuropsychiatric disease will be needed for controls.
Who cannot join
- No living subjects are enrolled in this protocol. Tissue is obtained after death, with the permission of next of kin, or from existing institutions with appropriate samples via an MTA or other applicable agreement.
- Brain tissue is excluded from collection if there is a previously known history of strokes, lesions, or other major neuropathological abnormalities prior to the consenting process.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
Office of the Chief Medical Examiner
Fairfax, Virginia, 22032
Office of the Chief Medical Examiner
Washington D.C., District of Columbia, 20003
About this study
Official title: Brain Procurement for the Human Brain Collection Core
The purpose of this study is to collect and study the brain tissue of deceased individuals to learn more about the nervous system and mental disorders. Information gained from donated tissue may lead to better treatments and potential cures for nervous system and mental disorders.
This study will ask relatives of deceased individuals to donate the brains of their deceased relatives to allow further study of neurological and psychiatric disorders. We do not accept prospective donations.
Read the detailed description
The knowledge of how affected tissue deviates from normal control tissue is an integral part of fully understanding a neurological or psychiatric disorder. The purpose of this protocol is to establish a coordinating program with the Office of the Chief Medical Examiner in Washington, DC, the Virginia Office of the Chief Medical Examiner, Central District, and Virginia the Office of the Chief Medical Examiner, Northern District for the donation of brain tissue.
Dissected brain tissue from selected brain regions, including but not limited to the dorsolateral prefrontal cortex and hippocampal formation, will be assembled from large cohorts of normal controls and schizophrenic subjects. The expression of mRNA and protein for selected molecules, chosen on the basis of their genetic association with schizophrenia, will be measured with a variety of assays including but not limited to qPCR and Western blots.
Outcome measures are the statistical comparison within normal controls of mRNA and/or protein levels in groups segmented by genotype. Similar comparisons will be made between schizophrenic cohorts and normal controls, in a diagnosis by genotype analysis with an ANOVA, or when appropriate an ANCOVA (controlling for variables such as age, race, gender, and postmortem interval).
- Conditions
- Bipolar Disorder, Depression, Anxiety Disorders, Schizophrenia, Tourette's Syndrome, Brain Diseases
- Keywords
- Schizophrenia, Neuropathology, Neurochemistry, Substance Abuse, Bipolar Disorder, Aging, Normal Development, Depression, Anxiety Disorders, Suicide, Dementia, Neuropsychiatric Disorders, Tourette's Syndrome, Normal Controls
- Medical subject headings
- Bipolar Disorder, Depression, Anxiety Disorders, Schizophrenia, Tourette Syndrome, Brain Diseases, Substance-Related Disorders, Suicide
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start29 May 1990
- Study completion16 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies 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
- Enrolment
- 2,161 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jose A Apud, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001260
- Sponsor's protocol ID
- 900142
- Other IDs
- 90-M-0142
- Status last verified
- 16 Jun 2017
- First submitted
- 3 Nov 1999
- Last updated
- 9 Dec 2019
- Results posted
- No
Publications
Meyer-Lindenberg A, Straub RE, Lipska BK, Verchinski BA, Goldberg T, Callicott JH, Egan MF, Huffaker SS, Mattay VS, Kolachana B, Kleinman JE, Weinberger DR. Genetic evidence implicating DARPP-32 in human frontostriatal structure, function, and cognition. J Clin Invest. 2007 Mar;117(3):672-82. doi: 10.1172/JCI30413. Epub 2007 Feb 8.
PubMed 17290303Law AJ, Lipska BK, Weickert CS, Hyde TM, Straub RE, Hashimoto R, Harrison PJ, Kleinman JE, Weinberger DR. Neuregulin 1 transcripts are differentially expressed in schizophrenia and regulated by 5' SNPs associated with the disease. Proc Natl Acad Sci U S A. 2006 Apr 25;103(17):6747-52. doi: 10.1073/pnas.0602002103. Epub 2006 Apr 17.
PubMed 16618933Egan MF, Straub RE, Goldberg TE, Yakub I, Callicott JH, Hariri AR, Mattay VS, Bertolino A, Hyde TM, Shannon-Weickert C, Akil M, Crook J, Vakkalanka RK, Balkissoon R, Gibbs RA, Kleinman JE, Weinberger DR. Variation in GRM3 affects cognition, prefrontal glutamate, and risk for schizophrenia. Proc Natl Acad Sci U S A. 2004 Aug 24;101(34):12604-9. doi: 10.1073/pnas.0405077101. Epub 2004 Aug 13.
PubMed 15310849Bowen EFW, Burgess JL, Granger R, Kleinman JE, Rhodes CH. DLPFC transcriptome defines two molecular subtypes of schizophrenia. Transl Psychiatry. 2019 May 9;9(1):147. doi: 10.1038/s41398-019-0472-z.
PubMed 31073119Mansur RB, Fries GR, Trevizol AP, Subramaniapillai M, Lovshin J, Lin K, Vinberg M, Ho RC, Brietzke E, McIntyre RS. The effect of body mass index on glucagon-like peptide receptor gene expression in the post mortem brain from individuals with mood and psychotic disorders. Eur Neuropsychopharmacol. 2019 Jan;29(1):137-146. doi: 10.1016/j.euroneuro.2018.10.007. Epub 2018 Nov 6.
PubMed 30409537Mansur RB, Fries GR, Subramaniapillai M, Frangou S, De Felice FG, Rasgon N, McEwen B, Brietzke E, McIntyre RS. Expression of dopamine signaling genes in the post-mortem brain of individuals with mental illnesses is moderated by body mass index and mediated by insulin signaling genes. J Psychiatr Res. 2018 Dec;107:128-135. doi: 10.1016/j.jpsychires.2018.10.020. Epub 2018 Oct 27.
PubMed 30391805Xiao X, Zhang C, Grigoroiu-Serbanescu M, Wang L, Li L, Zhou D, Yuan TF, Wang C, Chang H, Wu Y, Li Y, Wu DD, Yao YG, Li M. The cAMP responsive element-binding (CREB)-1 gene increases risk of major psychiatric disorders. Mol Psychiatry. 2018 Sep;23(9):1957-1967. doi: 10.1038/mp.2017.243. Epub 2017 Nov 21.
PubMed 29158582
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Procurement for the Human Brain Collection Core
- ClinicalTrials.gov ID
- NCT00001260
- Acronym / sponsor ID
- 900142
- Conditions
- Bipolar Disorder, Depression, Anxiety Disorders, Schizophrenia, Tourette's Syndrome, Brain Diseases
- Keywords
- Schizophrenia, Neuropathology, Neurochemistry, Substance Abuse, Bipolar Disorder, Aging, Normal Development, Depression
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 2,161 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 29 May 1990
- Study completion
- 16 Jun 2017
- First posted
- 4 Nov 1999 (estimated)
- 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.
The purpose of this study is to collect and study the brain tissue of deceased individuals to learn more about the nervous system and mental disorders. Information gained from donated tissue may lead to better treatments and potential cures for nervous system and mental disorders.
This study will ask relatives of deceased individuals to donate the brains of their deceased relatives to allow further study of neurological and psychiatric disorders. We do not accept prospective donations.
Detailed description
The knowledge of how affected tissue deviates from normal control tissue is an integral part of fully understanding a neurological or psychiatric disorder. The purpose of this protocol is to establish a coordinating program with the Office of the Chief Medical Examiner in Washington, DC, the Virginia Office of the Chief Medical Examiner, Central District, and Virginia the Office of the Chief Medical Examiner, Northern District for the donation of brain tissue.
Dissected brain tissue from selected brain regions, including but not limited to the dorsolateral prefrontal cortex and hippocampal formation, will be assembled from large cohorts of normal controls and schizophrenic subjects. The expression of mRNA and protein for selected molecules, chosen on the basis of their genetic association with schizophrenia, will be measured with a variety of assays including but not limited to qPCR and Western blots.
Outcome measures are the statistical comparison within normal controls of mRNA and/or protein levels in groups segmented by genotype. Similar comparisons will be made between schizophrenic cohorts and normal controls, in a diagnosis by genotype analysis with an ANOVA, or when appropriate an ANCOVA (controlling for variables such as age, race, gender, and postmortem interval).
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Brain tissue is needed from individuals suffering from a variety of neuropsychiatric disorders, especially schizophrenia, but also anxiety disorders, suicide, bipolar disorder, depression, Tourette's Syndrome, drug addictions (PCP, cocaine, alcohol, heroin or the like) and any form of dementia. In addition, brains from normal individuals without a history of neuropsychiatric disease will be needed for controls.
Key exclusion criteria (2 listed)
- No living subjects are enrolled in this protocol. Tissue is obtained after death, with the permission of next of kin, or from existing institutions with appropriate samples via an MTA or other applicable agreement.
- Brain tissue is excluded from collection if there is a previously known history of strokes, lesions, or other major neuropathological abnormalities prior to the consenting process.
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
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- Background: PubMed 17290303Meyer-Lindenberg A, Straub RE, Lipska BK, Verchinski BA, Goldberg T, Callicott JH, Egan MF, Huffaker SS, Mattay VS, Kolachana B, Kleinman JE, Weinberger DR. Genetic evidence implicating DARPP-32 in human frontostriatal structure, function, and cognition. J Clin Invest. 2007 Mar;117(3):672-82. doi: 10.1172/JCI30413. Epub 2007 Feb 8.
- Background: PubMed 16618933Law AJ, Lipska BK, Weickert CS, Hyde TM, Straub RE, Hashimoto R, Harrison PJ, Kleinman JE, Weinberger DR. Neuregulin 1 transcripts are differentially expressed in schizophrenia and regulated by 5' SNPs associated with the disease. Proc Natl Acad Sci U S A. 2006 Apr 25;103(17):6747-52. doi: 10.1073/pnas.0602002103. Epub 2006 Apr 17.
- Background: PubMed 15310849Egan MF, Straub RE, Goldberg TE, Yakub I, Callicott JH, Hariri AR, Mattay VS, Bertolino A, Hyde TM, Shannon-Weickert C, Akil M, Crook J, Vakkalanka RK, Balkissoon R, Gibbs RA, Kleinman JE, Weinberger DR. Variation in GRM3 affects cognition, prefrontal glutamate, and risk for schizophrenia. Proc Natl Acad Sci U S A. 2004 Aug 24;101(34):12604-9. doi: 10.1073/pnas.0405077101. Epub 2004 Aug 13.
- Derived from this study: PubMed 31073119Bowen EFW, Burgess JL, Granger R, Kleinman JE, Rhodes CH. DLPFC transcriptome defines two molecular subtypes of schizophrenia. Transl Psychiatry. 2019 May 9;9(1):147. doi: 10.1038/s41398-019-0472-z.
- Derived from this study: PubMed 30409537Mansur RB, Fries GR, Trevizol AP, Subramaniapillai M, Lovshin J, Lin K, Vinberg M, Ho RC, Brietzke E, McIntyre RS. The effect of body mass index on glucagon-like peptide receptor gene expression in the post mortem brain from individuals with mood and psychotic disorders. Eur Neuropsychopharmacol. 2019 Jan;29(1):137-146. doi: 10.1016/j.euroneuro.2018.10.007. Epub 2018 Nov 6.
- Derived from this study: PubMed 30391805Mansur RB, Fries GR, Subramaniapillai M, Frangou S, De Felice FG, Rasgon N, McEwen B, Brietzke E, McIntyre RS. Expression of dopamine signaling genes in the post-mortem brain of individuals with mental illnesses is moderated by body mass index and mediated by insulin signaling genes. J Psychiatr Res. 2018 Dec;107:128-135. doi: 10.1016/j.jpsychires.2018.10.020. Epub 2018 Oct 27.
- Derived from this study: PubMed 29158582Xiao X, Zhang C, Grigoroiu-Serbanescu M, Wang L, Li L, Zhou D, Yuan TF, Wang C, Chang H, Wu Y, Li Y, Wu DD, Yao YG, Li M. The cAMP responsive element-binding (CREB)-1 gene increases risk of major psychiatric disorders. Mol Psychiatry. 2018 Sep;23(9):1957-1967. doi: 10.1038/mp.2017.243. Epub 2017 Nov 21.
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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.
Jose A Apud, M.D. principal investigator
National Institute of Mental Health (NIMH)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder and Depression, run by National Institute of Mental Health (NIMH) at 3 sites 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 2 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 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001260, which also lists 7 linked publications.
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 9 Dec 2019.