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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00005914
Other study ID # R01MH061686-01
Secondary ID R01MH061686-01R0
Status Completed
Phase
First received
Last updated
Start date October 1999
Est. completion date October 2005

Study information

Verified date April 2019
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This nationwide study will create a DNA collection to permit qualified scientists to search for depression-related genes.

More than 750 families with at least two siblings who have experienced major depression are needed for the study. Participants will be interviewed about psychiatric and family history, and will be asked to provide a small blood specimen. The identification of predisposing genes can lead to greater understanding of the brain mechanisms involved in severe depression which can in turn lead to the discovery of new treatments.

A Certificate of Confidentiality from the federal government ensures that all information will be strictly confidential. Blood specimens are identified only by code number (not by name).

Reimbursement is provided.


Description:

Studies of patterns of major depression in families suggest that 50 to 70% of the predisposition to major depression is caused by genes. People with recurrent depression and earlier ages of onset have more relatives with depression. There are probably at least several interacting genes, rather than a single gene as in some disorders. The identification of predisposing genes is likely to lead to greater understanding of the brain mechanisms involved in severe depression. This could lead to the discovery of new treatments.

This study will create a DNA collection to permit qualified scientists to search for depression-related genes. More than 750 families with at least two siblings who have experienced major depression are needed for the study.

Participants in this study will be interviewed about psychiatric and family history, and will be asked for a small blood specimen. Interviews can be conducted in person or by telephone. For telephone interviews, blood sample collection will be arranged at a location and time convenient for the participant. Participants will also be asked for help in inviting other family members to participate. No family member will be contacted without the permission and assistance of another participating family member.

For information on a related study, please follow this link:

http://clinicaltrials.gov/show/NCT00260182


Recruitment information / eligibility

Status Completed
Enrollment 2533
Est. completion date October 2005
Est. primary completion date October 2005
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Families that have at least TWO ADULT SIBLINGS (brother/brother; sister/sister; brother/sister) who have experienced major depression.

- Depression must be RECURRENT (more than one episode).

- Depression must have started at age 30 or less in one sibling, and at age 40 or less in the other sibling.

Exclusion Criteria:

- Participants cannot have Bipolar I (manic-depressive) disorder or schizophrenia.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Johns Hopkins University Baltimore Maryland
United States Rush Presbyterian - Saint Luke's Med Ctr Chicago Illinois
United States Univ of Iowa Hosp and Clinic Iowa City Iowa
United States New York State Psychiatric Institute / Columbia Univ New York New York
United States Univ of Pennsylvania Philadelphia Pennsylvania
United States Univ of Pittsburgh / Western Psychiatric Inst and Clinic Pittsburgh Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Stanford University National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Major depressive disorder Participants will attend an interview regarding personal and family history of psychiatric disorders, and give a blood specimen. Genotypes from blood samples will be studied for genetic linkage (within families) with the presence of major depressive disorder. One patient interview session (typically 2 hours), and blood draw (10-20 minutes)
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