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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 : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )

Tracking Information
First Submitted Date November 3, 1999
First Posted Date November 4, 1999
Last Update Posted Date July 1, 2019
Study Start Date July 6, 1995
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: February 21, 2019)
Genetic Polymorphisms affect phenotypes [ Time Frame: 1 year ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00001486 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 21, 2019)
PANSS, AIMS, GAF [ Time Frame: 1 year ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Genetic Study of Schizophrenia
Official Title A Neurobiological Investigation of Patients With Schizophrenia Spectrum Disorders and Their Siblings
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.
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, and a variety of parameters using brain imaging and magnetoencephalography.

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 Type Observational
Study Design Observational Model: Case-Control
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with schizophrenia and their siblings will be recruited through families of current or former patients at NIMH, physician referrals and both local and national sources.
Condition
  • Psychotic Disorder
  • Schizoaffective Disorder
  • Schizophrenia
Intervention Not Provided
Study Groups/Cohorts
  • 1
    1000 pairs of siblings
  • 2
    1000 trios consisting of 1 patient and 2 parents
  • 3
    1750 healthy volunteers
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 16, 2013)
6150
Original Enrollment
 (submitted: June 23, 2005)
5400
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility 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 who do not have capacity to provide consent and are under guardianship can participate in the study if the guardian signs the informed consent and the research subject provides their written assent. A DPA is not utilized in this study.
  • 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.
  • Documented metal in the body, e.g. from fixed dental bridges, orthodontia braces, IUDs containing metal or surgical screws.
  • Weight and height dimensions that result in size exceeding the capability of the MRI bore circumference is exclusionary.
  • 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.

Healthy Controls Inclusion Criteria:

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..
  • Documented presence of metal such as orthodontia braces, surgical screws or IUD of metal composition.
  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Joann G Berkson, R.N. (301) 451-0167 berksonj@mail.nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00001486
Other Study ID Numbers 950150
95-M-0150
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
Study Sponsor National Institute of Mental Health (NIMH)
Collaborators Not Provided
Investigators
Principal Investigator: Karen F Berman, M.D. National Institute of Mental Health (NIMH)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date June 26, 2019