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Genetic Study of Schizophrenia

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ClinicalTrials.gov Identifier: NCT00001486
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : February 14, 2023
Sponsor:
Collaborator:
National Institutes of Health Clinical Center (CC)
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )

Study Description
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Brief Summary:
This large ongoing study at NIMH investigates the neurobiology of schizophrenia by identifying susceptibility genes, evaluating their impact on brain function to better understand how to treat and prevent this illness.

Condition or disease
Schizoaffective Disorder Schizophrenia

Detailed Description:

Objective: Schizophrenia is a complex genetic disorder which likely involves many genes each producing a slight increase in risk. Finding weak-acting genes in complex genetic disorders has been challenging and will likely require a number of approaches and large clinical samples. Several strategies have emerged recently that appear to markedly improve the power of genetic studies for detecting such genes. These include using association (rather than linkage) and using intermediate phenotypes in addition to DMS-IV diagnosis.

Study Population: We propose to take advantage of these techniques by studying quantitative traits related to schizophrenia in patients, siblings, and controls.

Design: We will employ an association design, rather than linkage. Traits will include quantifiable neurobiological variables that have been implicated previously as possible phenotypes related to schizophrenia. These include tests of attention and cognition.

Outcome Measure: We will use several statistical methods to show that specific genetic polymorphisms affect these phenotypes, including case control and family based association studies.

Study Design
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Study Type : Observational
Estimated Enrollment : 6150 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: A Neurobiological Investigation of Patients With Schizophrenia Spectrum Disorders and Their Siblings
Actual Study Start Date : July 15, 1995

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Groups and Cohorts
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Group/Cohort
Normal Controls
Male and female adult healthy volunteers
Parents
Parents of Probands and siblings for the purposes of DNA collection
Probands
Adult Subjects with Schizophrenia Spectrum Disorders
Siblings
Adult siblings of Probands


Outcome Measures
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Primary Outcome Measures :
  1. Genetic Polymorphisms affect phenotypes [ Time Frame: At time of study participation ]
    genotyping analysis


Secondary Outcome Measures :
  1. PANSS, AIMS, GAF [ Time Frame: At time of study participation ]
    PANSS, AIMS, GAF


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Probands, healthy controls, siblings, parents
Criteria
  • INCLUSION/EXCLUSION CRITERIA:

Inclusion criteria for Siblings (probands and unaffected siblings):

  • Probands must have a DSM IV-R diagnosis of schizophrenia,schizoaffective disorder, psychosis N.O.S. or schizophreniform disorder.
  • Probands and Siblings must be between the ages of 18 and 55
  • Probands and Siblings must be free of major medical illnesses, but may have controlled hypertension, thyroid disease, or diabetes.
  • Probands and Siblings must have the cognitive ability to consent for themselves. Those who are judged to have the cognitive ability to consent for themselves at the time of participation, but do not have the legal capacity to consent for themselves may participate if the legal guardian /Legal authorized representative (LAR) provides consent by signing the informed consent form.
  • Fluency in English is required.

Exclusion Criteria for Siblings (probands and unaffected siblings):

  • Seizure disorder, mental retardation, organic brain damage or other neurological disease.
  • History of any (excepting nicotine-related) DSM5-defined moderate to severe substance use disorder (or DSM-IV-defined substance dependence).
  • Cumulative lifetime history of any (excepting nicotine-related) DSM5-defined mild substance use disorder (or any DSM-IV-defined substance abuse), either in excess of 5 years total or not in remission for at least 6 months.
  • Head trauma with loss of consciousness over 5 minutes from all but genetic sampling.
  • Chemotherapy.
  • NIMH employees/staff and their immediate family members will be excluded from the study per NIMH policy

Siblings who do not qualify for the 2-day or 1-day study, may participate in the limited phenotyping arm in which only a psychiatric interview and a blood draw for genetic analysis (SCID-DNA) will be performed, case control analysis or be included as part of a trio (one parent, one sibling, one patient) to study genetic transmission from parents to offsprings.. All parents are eligible for the study.

Inclusion Criteria. Healthy Volunteers/Controls

To be eligible for this research study, healthy volunteers must be:

  • Between the ages of 18 and 55
  • Fluency in English is required

Healthy Controls Exclusion Criteria:

They will not be eligible if:

  • They have history of DSM IV-R psychiatric diagnosis or severe chronic medical illness at the time of the study.
  • They have a history of any (excepting nicotine-related) DSM5-defined moderate to severe substance use disorder (or DSM-IV-defined substance dependence).
  • They have a cumulative lifetime history of any (excepting nicotine-related) DSM5-defined mild substance use disorder (or any DSM-IV-defined substance abuse), either in excess of 5 years total or not in remission for at least 6 months.
  • They may not be eligible for the 2-day or 1-day study if they have a first-degree relative with history of schizophrenia spectrum disorders. However, they may be included in the SCID_DNA or case control analyses.
  • Healthy volunteers must be free of learning disabilities.
  • NIMH employees/staff and their immediate family members will be excluded from the study per NIMH policy.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT00001486


Contacts
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Contact: Joann G Berkson, R.N. (301) 451-0167 berksonj@mail.nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY dial 711    ccopr@nih.gov   
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
National Institutes of Health Clinical Center (CC)
Investigators
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Principal Investigator: Karen F Berman, M.D. National Institute of Mental Health (NIMH)
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00001486    
Other Study ID Numbers: 950150
95-M-0150
First Posted: November 4, 1999    Key Record Dates
Last Update Posted: February 14, 2023
Last Verified: February 10, 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) ):
Negative Symptoms
Brain Scans
Hallucinations
 Delusions
Psychosis and Schizophrenia
Natural History
Additional relevant MeSH terms:
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Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders