DepressionGenREDNCT00005914
Genetics of Recurrent Early-Onset Depression
An observational study of Depression, run by Stanford University at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- How many people
- 2,533 participants
- Where
- 6 sitesUnited States
- Study dates
- Oct 1999to Oct 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Probands will have major depressive disorder meeting the eligibility criteria described below.
Who may be able to join
- 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.
Who cannot join
- Participants cannot have Bipolar I (manic-depressive) disorder or schizophrenia.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Johns Hopkins University
Baltimore, Maryland, 21287-7381
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
Univ of Iowa Hosp and Clinic
Iowa City, Iowa, 52242
New York State Psychiatric Institute / Columbia Univ
New York, New York, 10032
Univ of Pennsylvania
Philadelphia, Pennsylvania, 19104-2648
Univ of Pittsburgh / Western Psychiatric Inst and Clinic
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read more
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.
Read the 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
- Conditions
- Depression
- Keywords
- Depression, Depressive Disorder, Family, Genes, Genetic Techniques, Genetics, Linkage (Genetics), Nuclear Family, Recurrence, Severity of Illness Index
- Medical subject headings
- Depression, Depressive Disorder, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One patient interview session (typically 2 hours), and blood draw (10-20 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2000 (estimated)
- Study startOct 1999
- Primary completionOct 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Retrospective
- Enrolment
- 2,533 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Douglas F. Levinson, Stanford University
- Investigators
- Myrna Weissman, Principal investigator, Columbia UniversityJ R DePaulo, Principal investigator, Johns Hopkins UniversityWilliam Scheftner, Principal investigator, Rush University HospitalRaymond Crowe, Principal investigator, University of IowaDouglas Levinson, Principal investigator, University of PennsylvaniaGeorge Zubenko, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005914
- Sponsor's protocol ID
- R01MH061686-01
- Other IDs
- R01MH061686-01, R01MH060912, R01MH059552, R01MH059541, R01MH059542, R01MH061686, R01MH060866, DNBBS 7G-GRR
- Acronym
- GenRED
- Status last verified
- Apr 2019
- First submitted
- 15 Jun 2000
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetics of Recurrent Early-Onset Depression
- ClinicalTrials.gov ID
- NCT00005914
- Acronym / sponsor ID
- GenRED / R01MH061686-01
- Conditions
- Depression
- Keywords
- Depression, Depressive Disorder, Family, Genes, Genetic Techniques, Genetics, Linkage (Genetics), Nuclear Family
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,533 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 1999
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 16 Jun 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Family based
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Probands will have major depressive disorder meeting the eligibility criteria described below.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Participants cannot have Bipolar I (manic-depressive) disorder or schizophrenia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
- Web site for New York Psychiatric InstituteLink provided by the sponsor.
- Web site for University of IowaLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myrna Weissman principal investigator
Columbia University
J R DePaulo principal investigator
Johns Hopkins University
William Scheftner principal investigator
Rush University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by Stanford University at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major depressive disorder (time frame: One patient interview session (typically 2 hours), and blood draw (10-20 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2019.