The purpose of this study is to identify genes that may affect a person's chances of developing bipolar (BP) disorder and related conditions.

BP disorder is a serious and potentially life-threatening mood disorder. The condition can be inherited, but the mode of inheritance is poorly understood and probably involves multiple genes. This study will detect and localize genes that increase or decrease chances of developing BP disorder. Families with siblings who have bipolar disorder will be studied to obtain information for a national archival database of BP disorder genetic data.

Condition
Anxiety Disorder Bipolar Disorder Healthy Mood Disorder Schizophrenia

Further Study Details: 

Expected Total Enrollment:  2900

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.

Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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.

Maryland
      National Institute of Mental Health (NIMH), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States; Recruiting

Study ID Numbers:  800083; 80-M-0083
Record last reviewed:  July 27, 2004
Last Updated:  November 23, 2004
Record first received:  November 3, 1999
ClinicalTrials.gov Identifier:  NCT00001174
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08