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Evaluation of the Genetics of Bipolar Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
ClinicalTrials.gov Identifier:
NCT00001174
First received: November 3, 1999
Last updated: November 11, 2014
Last verified: January 2014

November 3, 1999
November 11, 2014
August 1980
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Complete list of historical versions of study NCT00001174 on ClinicalTrials.gov Archive Site
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Evaluation of the Genetics of Bipolar Disorder
Bipolar Genetics: A Collaborative Study

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

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 will shift 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.

Observational
Time Perspective: Retrospective
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  • Mania
  • Bipolar, Disorder
  • Depression
  • Mood Disorder
  • Schizoaffective
  • Manic Depression
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
4000
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  • INCLUSION CRITERIA:

Age > 18 yr

Able to provide informed consent

Diagnosed with bipolar disorder not attributable to substance abuse, neurological disease; or a 1st or 2nd degree relative of an enrolled participant

Able to safely provide a blood or saliva sample

EXCLUSION CRITERIA:

Active alcohol or substance abuse

Both
18 Years and older
Yes
Contact: Francis J McMahon, M.D. (301) 451-4453 mcmahonf@mail.nih.gov
United States
 
NCT00001174
800083, 80-M-0083
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National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
National Institute of Mental Health (NIMH)
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Principal Investigator: Francis J McMahon, M.D. National Institute of Mental Health (NIMH)
National Institutes of Health Clinical Center (CC)
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP