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Sponsors and Collaborators: |
University of Maryland National Institutes of Health (NIH) |
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Information provided by: | University of Maryland |
ClinicalTrials.gov Identifier: | NCT00666432 |
Briefly, this multisite study is designed to identify endophenotypes (i.e., heritable biomarkers) associated with either schizophrenia or bipolar disorder alone, or both together. The subsequent genetic analyses will search genomic loci and candidate genes associated with each of the independent endophenotypes. This is a five site study that is slotted for NIMH funding.
Condition |
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Schizophrenia Bipolar |
Study Type: | Observational |
Study Design: | Family-Based |
Official Title: | Bipolar and Schizophrenia Consortium for Parsing Intermediate Phenotypes |
Blood or saliva will be stored for future genetic analysis.
Estimated Enrollment: | 3500 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | September 2012 |
Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
Controls
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Patient Family
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Patients
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We propose to recruit 100 case probands with a diagnosis of SZ, 100 case probands with a diagnosis of BP Disorder I with history of psychosis; BPI-P) and 400 1st degree case relatives. All 1st degree family members who are willing to participate will provide clinical information and blood sample, only a proportion will be eligible for endophenotypic studies). Individuals with psychotic disorder not otherwise specified are also eligible for testing. Their data will be incorporated with the schizophrenia or bipolar data upon confirmation of diagnosis. Family members of individuals with psychotic disorder not otherwise specified will not be tested unless the individual has a later confirmed diagnosis of schizophrenia or bipolar disorder. Probands will not be tested during the acute phase of the illness as judged clinically e.g., significant increase in core symptoms from their stable baseline that requires a change in treatment such increased dose of medication, drug change, or hospitalization). As part of another existing protocol, we have collected most of the endophynotypic information in schizophrenia probands and 1st degree relatives other than brain imaging and few other tests. We will attempt to recruit these subjects to complete the imaging studies and the data will be used in the current study.
We will recruit 100 healthy comparison subjects from the community in order to describe the distribution of normal values for our endophenotype procedures in a demographically matched sample. The SZ and BPI-P probands, and 50 healthy control subjects, will be frequency matched on age, sex ratio, and head of the household's socio-economic status (SES). Another group of 50 healthy control subjects will be similarly matched to the relative groups recruited.
Participants will undergo a number of clinical, electrophysiological, structural brain imaging, perceptual, and cognitive assessments. These data will be used to identify phenotypes likely to be associated with genetic risk for schizophrenia and/or bipolar disorder, and to determine how these phenotypes aggregate in families. Some of the analyses will focus on examining associations between candidate genes and these alternative phenotypes. Thus if we are not able to recruit relatives we may still collect these phenotypic data in probands and their genetic sample for future genotype/phenotype association studies. Family members may elect to participate only in the clinical and blood draw portions of the study. Testing procedures require a 12 -15 hour time commitment and testing will be completed over 2 or more days. Participants will be asked to give a blood (or saliva if difficult to obtain blood sample for instance because of fear of blood draws), which will be stored for future genetic analyses. Data from the previous family study will be combined with the data collected in this protocol for some of the analyses.
Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Subjects will be recruited from the University of Maryland, Community Mental Health Center and Private Psychiatrists.
Inclusion Criteria:
Exclusion Criteria:
Contact: Jennifer Jones | 410-402-6823 | jjones@mprc.umaryland.edu |
Contact: Karen Fellenz | 410-402-6829 | kfellenz@mprc.umaryland.edu |
United States, Connecticut | |
Hartford Hospital- The Institute of Living | Recruiting |
Hartford, Connecticut, United States, 06106 | |
Contact: Ray Lorenzoni 860-545-7888 Rlorenzoni@harthosp.org | |
Principal Investigator: Godfrey Pearlson, MD | |
United States, Illinois | |
Center for Cognitive Medicine | Recruiting |
Chicago, Illinois, United States, 60612 | |
Contact: Jami Honeyman 312-355-5549 jhoneyman@psych.uic.edu | |
Principal Investigator: John A Sweeney, PhD | |
United States, Maryland | |
University of Maryland, Baltimore | Recruiting |
Baltimore, Maryland, United States, 21228 | |
Contact: Jennifer Jones 410-402-6823 jjones@mprc.umaryland.edu | |
Principal Investigator: Gunvant K Thaker, M.D. | |
Sub-Investigator: Ikwunga Wonodi, M.D. | |
Sub-Investigator: L E Hong, M.D. | |
Johns Hopkins School of Medicine | Recruiting |
Baltimore, Maryland, United States, 21201 | |
Contact: Shaina Fieldstone sfields9@jhmi.edu | |
Sub-Investigator: David Schretlen, PhD | |
United States, Michigan | |
Wayne State University School of Medicine | Recruiting |
Detroit, Michigan, United States, 48201 | |
Contact: Mae Nordin 800-650-7837 mnordin@med.wayne.edu | |
Principal Investigator: Matcheri S Keshavan, MD | |
United States, Texas | |
University of Texas Southwestern Medical Center | Recruiting |
Dallas, Texas, United States, 75390 | |
Contact: Elena Ivleva 214-645-2789 Elena.Ivleva@UTSouthwestern.edu | |
Principal Investigator: Carol Tamminga, MD |
Principal Investigator: | Gunvant K Thaker, M.D. | University of Maryland |
Responsible Party: | University of Maryland, Baltimore ( Gunvant K. Thaker ) |
Study ID Numbers: | H29481 |
Study First Received: | April 21, 2008 |
Last Updated: | October 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00666432 |
Health Authority: | United States: Institutional Review Board |
schizophrenia bipolar eye movements |
phenotype biochemical relatives |
Schizophrenia Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |