DepressionNCT00260182
Genetics of Recurrent Early Onset Major Depression
An observational study of Depression, run by Stanford University at 6 sites in United States.
Trial summary
This study will identify specific genes that may cause a predisposition to depression in some families. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- How many people
- 2,302 participants
- Where
- 6 sitesUnited States
- Study dates
- Oct 2005to Jun 2009
- 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 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will include participants with a family history of depression.
Who may be able to join
- History of recurrent major depression
- Has a parent or sibling with a history of recurrent major depression
- Depression began before the age of 31
Who cannot join
- Bipolar I (manic-depressive) disorder
- Schizophrenia
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Rush University Medical Center
Chicago, Illinois, 60612
University of Iowa
Iowa City, Iowa, 52242
Columbia University/New York State Psychiatric Institute
New York, New York, 10032
Stanford University
Palo Alto, California, 94304
Howard University
Washington D.C., District of Columbia, 20060
About this study
This study will identify specific genes that may cause a predisposition to depression in some families.
Read the detailed description
Depression is a serious medical illness that is often difficult to diagnose and treat. Studies on patterns of depression within families suggest that inherited genes may cause a predisposition to the disorder. People with early onset depression often have more relatives with depression than people whose depression does not begin until later in life. It is likely that several interacting genes cause this tendency towards the disorder, rather than one specific gene. This study will serve to identify particular genes that may cause a susceptibility to depression in order to better understand the brain mechanisms involved with severe depression. In turn, this may aid in the development of new treatments for depression.
Participation in this observational study will entail one interview and one blood test. Participants will be interviewed, either in person or by telephone, about their personal and family psychiatric history. The blood sample will be collected at a time and location that is convenient for the participant. Participants may also be asked to invite other family members to participate in the study.
For information on a related study please follow this link:
http://clinicaltrials.gov/show/NCT00005914
- Conditions
- Depression
- Keywords
- Depressive Disorder, Family, Genetics
- Medical subject headings
- Depression, Depressive Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Major depressive disorder diagnosis
The study will correlate genome-wide SNP genotypes with case vs. control status, defined by presence or absence of 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 association with 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 posted1 Dec 2005 (estimated)
- Study startOct 2005
- Primary completionJun 2009
- Study completionJun 2009
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,302 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
- Douglas F. Levinson, MD, Principal investigator, Stanford UniversityMyrna M. Weissman, PhD, Principal investigator, Columbia University/New York State Psychiatric InstituteJ. Raymond DePaulo, MD, Principal investigator, Johns Hopkins UniversityWilliam A. Scheftner, MD, Principal investigator, Rush University Medical CenterWilliam Coryell, MD, Principal investigator, University of IowaWilliam Lawson, MD, Principal investigator, Howard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260182
- Sponsor's protocol ID
- R01MH061686-02
- Other IDs
- R01MH061686-02, R01MH059542, R01MH059552, R01MH075131, R01MH059541, R01MH060912, DNBBS 7G-GRR
- Status last verified
- Apr 2019
- First submitted
- 28 Nov 2005
- Last updated
- 19 Apr 2019
- Results posted
- 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 Major Depression
- ClinicalTrials.gov ID
- NCT00260182
- Acronym / sponsor ID
- R01MH061686-02
- Conditions
- Depression
- Keywords
- Depressive Disorder, Family, Genetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,302 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2005
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 1 Dec 2005 (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 study will identify specific genes that may cause a predisposition to depression in some families.
Detailed description
Depression is a serious medical illness that is often difficult to diagnose and treat. Studies on patterns of depression within families suggest that inherited genes may cause a predisposition to the disorder. People with early onset depression often have more relatives with depression than people whose depression does not begin until later in life. It is likely that several interacting genes cause this tendency towards the disorder, rather than one specific gene. This study will serve to identify particular genes that may cause a susceptibility to depression in order to better understand the brain mechanisms involved with severe depression. In turn, this may aid in the development of new treatments for depression.
Participation in this observational study will entail one interview and one blood test. Participants will be interviewed, either in person or by telephone, about their personal and family psychiatric history. The blood sample will be collected at a time and location that is convenient for the participant. Participants may also be asked to invite other family members to participate in the study.
For information on a related study please follow this link:
http://clinicaltrials.gov/show/NCT00005914
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include participants with a family history of depression.
Key inclusion criteria (3 listed)
- History of recurrent major depression
- Has a parent or sibling with a history of recurrent major depression
- Depression began before the age of 31
Key exclusion criteria (2 listed)
- Bipolar I (manic-depressive) disorder
- 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 diagnosis
Time frame: One patient interview session (typically 2 hours), and blood draw (10-20 minutes)
The study will correlate genome-wide SNP genotypes with case vs. control status, defined by presence or absence of 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 association with 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.
- Click here for the Stanford University study web pageLink 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.
Douglas F. Levinson, MD principal investigator
Stanford University
Myrna M. Weissman, PhD principal investigator
Columbia University/New York State Psychiatric Institute
J. Raymond DePaulo, MD principal investigator
Johns Hopkins University
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 2 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 diagnosis (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.