Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Evaluation of the Genetics of Bipolar Disorder
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), July 2008
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001174
  Purpose

This study looks to identify genes that may affect a person's chances of developing bipolar disorder (BP) and related conditions.


Condition
Mania
Bipolar, Disorder
Depression
Mood Disorder
Schizoaffective
Manic Depression

MedlinePlus related topics: Bipolar Disorder Depression
U.S. FDA Resources
Study Type: Observational
Study Design: Retrospective
Official Title: Bipolar Genetics: A Collaborative Study

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 4000
Study Start Date: August 1980
Detailed Description:

Bipolar affective disorder is a severe, heritable condition affecting about one percent of the population. The mode of inheritance is poorly understood and probably involves multiple loci of small to moderate effect. Genetic linkage has been reported to a number of chromosomal regions; some findings have been replicated. In 1988 the NIMH began a national archival database to search for susceptibility loci/genes in this condition. Its purpose was to collect a large sample of interviews and cell lines from families suitable for linkage and association studies. Since 1988, the NIMH-IRP has been an active site in this multi-center study. The protocol was originally supervised by Elliot Gershon, MD (1988-July 1998) and Dennis L. Murphy, MD (July 1998 - January 2004). In January 2004, Francis J. McMahon, M.D, took over supervision of the protocol. An expanded Consortium of sites concentrating on families identified through a sib pair was approved in August 1998 by the NIMH Extramural Program (MH 59535) via a competitive application. This Consortium added 450 new families and 2500 cell lines. Cell lines, clinical data, and 2 genome-wide sets of microsatellite genotypes have been made freely available to the scientific community under the auspices of the NIMH Center for Genetic Studies. In 2003, the IRB approved an amendment to expand the ascertainment criteria to include sib-pairs with a diagnosis of bipolar II disorder. Families ascertained in this manner are contributed to a second, large sample being collected in collaboration with The Johns Hopkins University and the University of Chicago, known as the CHIP study. In October 2003, the NIMH Extramural Program approved, via a competitive application, an additional 4 years of support for the Consortium collection, now including 11 extramural sites in addition to the IRP site. In this round, the focus shifted from affected sibling pairs to parent-affected offspring triads, with the goal of accruing a large sample suitable for future association studies. Both the Consortium and CHIP projects have similar study design and essentially identical recruitment, evaluation, and analysis procedures, so both projects are described together in what follows. In 2007, probands from the Consortium sample were selected for genome-wide genotyping under the Genetic Association Information Network (GAIN) initiative; a project aimed at producing genome-wide data for use by the scientific community in the discovery of genes involved in common disorders.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION AND EXCLUSION CRITERIA:

The major goal of this project is to collect a sample of affected sibling pairs and cases with familial bipolar disorder, and to use this sample, along with control samples independently available, to identify vulnerability genes for bipolar disorder.

For the Consortium collection, the DSM-IV diagnosis of BPI is our definition of affected status. It is anticipated that a small number (less than 5%) of subjects ascertained as BPI is judged at the time of best estimate to have another diagnosis (primarily BPII, SA (BP) or organic mood disorder) and they are flagged in the dataset so as not to include them in primary analyses.

For the CHIP collection, we will screen families of treated BP I probands who by family history have at least 2 other siblings with recurrent major mood disorders including BP I, BP II, recurrent major depression, or schizoaffective disorder, bipolar type. This strategy has allowed us to include in our sample the full range of natural clinical variation associated with BPD.

Probands are recruited from a broad range of sources, including clinic populations, inpatient admissions, patient advocacy groups, and the public media. Prospective probands are asked to provide information about themselves and their first-degree relatives, using the screening and checklist questions for mood disorders contained in the FIGS. All probands aged 21 or over who can provide informed consent for interview and phlebotomy are enrolled.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001174

Contacts
Contact: Diane M. Kazuba (301) 496-8977 kazubad@intra.nimh.nih.gov
Contact: Layla Kassem (301) 451-4255 kasseml@intra.nimh.nih.gov

Locations
United States, California
University of California, Irvine Medical Center Recruiting
Orange, California, United States, 92668
University of California, San Diego Recruiting
La Jolla, California, United States, 92093-0603
United States, District of Columbia
Howard University Hospital Recruiting
Washington, District of Columbia, United States, 20060
United States, Illinois
Rush Presbyterian St. Luke's Medical Center Recruiting
Chicago, Illinois, United States, 60612
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202-5262
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40292
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
United States, Michigan
Wayne State University Hutzel Hospital Recruiting
Detroit, Michigan, United States, 48201
United States, Missouri
Washington University, St. Louis Recruiting
St. Louis, Missouri, United States, 63110
United States, New York
SUNY Recruiting
Stonybrook, New York, United States
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104-6056
Sponsors and Collaborators
  More Information

NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site

Publications:
Study ID Numbers: 800083, 80-M-0083
Study First Received: November 3, 1999
Last Updated: August 1, 2008
ClinicalTrials.gov Identifier: NCT00001174  
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Bipolar Manic-Depressive Illness
Affective Disorder
Depression
Genetic
DNA
Mania
Affected Sibling Pairs
Family Study
Genome-wide scan
lymphoblastoid cell lines
Diagnostic Interview for Genetic Studies (DIGS)
Panic Disorder
Bipolar Disorder

Study placed in the following topic categories:
Affective Disorders, Psychotic
Panic Disorder
Depression
Mental Disorders
Bipolar Disorder
Mood Disorders
Psychotic Disorders
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:
Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 30, 2009