NCT00005914

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,533

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 1999

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2000

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

April 19, 2019

Status Verified

April 1, 2019

Enrollment Period

6 years

First QC Date

June 15, 2000

Last Update Submit

April 16, 2019

Conditions

Keywords

DepressionDepressive DisorderFamilyGenesGenetic TechniquesGeneticsLinkage (Genetics)Nuclear FamilyRecurrenceSeverity of Illness Index

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, 60612, United States

Location

Univ of Iowa Hosp and Clinic

Iowa City, Iowa, 52242, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287-7381, United States

Location

New York State Psychiatric Institute / Columbia Univ

New York, New York, 10032, United States

Location

Univ of Pennsylvania

Philadelphia, Pennsylvania, 19104-2648, United States

Location

Univ of Pittsburgh / Western Psychiatric Inst and Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood specimens were submitted to the NIMH repository at the Rutgers University Cell and DNA Repository.

MeSH Terms

Conditions

DepressionDepressive DisorderRecurrence

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMood DisordersMental DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

June 15, 2000

First Posted

June 16, 2000

Study Start

October 1, 1999

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

April 19, 2019

Record last verified: 2019-04

Locations