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Brain Tissue Collection for Neuropathological Studies

Primary Purpose

Bipolar Disorder, Depression, Anxiety Disorders

Status
Terminated
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Mental Health (NIMH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Bipolar Disorder focused on measuring Schizophrenia, Neuropathology, Neurochemistry, Substance Abuse, Bipolar Disorder, Aging, Normal Development, Depression, Anxiety Disorders, Suicide, Dementia, Neuropsychiatric Disorders, Tourette's Syndrome, Normal Controls

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

INCLUSION CRITERIA: 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. EXCLUSION CRITERIA: 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.

Sites / Locations

  • Office of the Chief Medical Examiner
  • National Institutes of Health Clinical Center, 9000 Rockville Pike
  • Office of the Chief Medical Examiner

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
December 6, 2019
Sponsor
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00001260
Brief Title
Brain Tissue Collection for Neuropathological Studies
Official Title
Brain Procurement for the Human Brain Collection Core
Study Type
Observational

2. Study Status

Record Verification Date
June 16, 2017
Overall Recruitment Status
Terminated
Study Start Date
May 29, 1990 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 16, 2017 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

Brief 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Enrollment
2161 (Actual)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA: 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. EXCLUSION CRITERIA: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose A Apud, M.D.
Organizational Affiliation
National Institute of Mental Health (NIMH)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Office of the Chief Medical Examiner
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20003
Country
United States
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Facility Name
Office of the Chief Medical Examiner
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17290303
Citation
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.
Results Reference
background
PubMed Identifier
16618933
Citation
Law 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.
Results Reference
background
PubMed Identifier
15310849
Citation
Egan 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.
Results Reference
background
PubMed Identifier
31073119
Citation
Bowen 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. Erratum In: Transl Psychiatry. 2019 Jun 12;9(1):169.
Results Reference
derived
PubMed Identifier
30409537
Citation
Mansur 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.
Results Reference
derived
PubMed Identifier
30391805
Citation
Mansur 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.
Results Reference
derived
PubMed Identifier
29158582
Citation
Xiao 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.
Results Reference
derived

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Brain Tissue Collection for Neuropathological Studies

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