Genetics of Recurrent Early-Onset Depression (GenRED)

April 16, 2019 updated by: Douglas F. Levinson, Stanford University

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.

Study Overview

Status

Completed

Conditions

Detailed 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

Study Type

Observational

Enrollment (Actual)

2533

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Presbyterian - Saint Luke's Med Ctr
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Univ of Iowa Hosp and Clinic
    • Maryland
      • Baltimore, Maryland, United States, 21287-7381
        • Johns Hopkins University
    • New York
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute / Columbia Univ
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-2648
        • Univ of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Univ of Pittsburgh / Western Psychiatric Inst and Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Probands will have major depressive disorder meeting the eligibility criteria described below.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Probands and family members
Individuals with major depressive disorder who meet study criteria, and members of their families. No intervention. This is a genetic study only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major depressive disorder
Time Frame: One patient interview session (typically 2 hours), and blood draw (10-20 minutes)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Myrna Weissman, Columbia University
  • Principal Investigator: J R DePaulo, Johns Hopkins University
  • Principal Investigator: William Scheftner, Rush University Hospital
  • Principal Investigator: Raymond Crowe, University of Iowa
  • Principal Investigator: Douglas Levinson, University of Pennsylvania
  • Principal Investigator: George Zubenko, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1999

Primary Completion (Actual)

October 1, 2005

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

June 15, 2000

First Submitted That Met QC Criteria

June 15, 2000

First Posted (Estimate)

June 16, 2000

Study Record Updates

Last Update Posted (Actual)

April 19, 2019

Last Update Submitted That Met QC Criteria

April 16, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • R01MH061686-01 (U.S. NIH Grant/Contract)
  • R01MH059542 (U.S. NIH Grant/Contract)
  • R01MH059552 (U.S. NIH Grant/Contract)
  • R01MH059541 (U.S. NIH Grant/Contract)
  • R01MH060912 (U.S. NIH Grant/Contract)
  • DNBBS 7G-GRR
  • R01MH061686 (U.S. NIH Grant/Contract)
  • R01MH060866 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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