Major Depressive DisorderNCT01831882
Identifying Biological Markers for Severe Depression
An observational study of Major Depressive Disorder, run by Stanford University at 3 sites in United States.
Trial summary
The primary objective of this study is to investigate the biological components of major depression. The investigators are particularity interested in genetic variation and how it contributes to cortisol (because cortisol is higher in severe depression than mild depression or healthy controls) and how it contributes… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- How many people
- 210 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2013to Aug 2020
- 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: Inpatient hospitals, outpatient clinics, community.
Who may be able to join
- Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) diagnosis of Unipolar Major Depressive Disorder with or without psychotic features.
- 21-item Hamilton Depression Rating Scale (HDRS) score greater than or equal to 21.
- Thase Core Endogenomorphic Scale score greater than or equal to 8 on the items included in the 21-item HDRS.
- Between 18 - 70 years of age.
- If currently taking antipsychotic, antidepressant, anticonvulsant, and/or mood-stabilizing medications, must be stable on the medication for at least one-week prior to entering the study.
- Pre-existing (current) primary treating psychiatrist for subjects with psychotic features.
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- Any secondary diagnoses from the anxiety disorder spectrum is acceptable. Primary pre-existing chronic Obsessive-Compulsive Disorder (OCD) will be an exclusion criteria.
- Between 18 - 70 years of age.
- Have a HAM-D score of less than or equal to 5.
Who cannot join
- Electroconvulsive Therapy (ECT) in the 6 months prior to the study.
- Abuse of drugs or alcohol in the 6 months prior to study.
- Unstable or untreated hypertension or cardiovascular disease.
- Use of additional prescription medications, street drugs, or alcohol during the week before the study.
- Any Axis II diagnosis or traits which would make participation in the study difficult.
- Current pregnancy or lactation.
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- Post-partum depression
- Diagnosis of obsessive-compulsive disorder
- History of significant cognitive decline
- Personal history of Axis I or Axis II disorders.
- Active unstable medical problems.
- Abuse of drugs or alcohol in the 6 months prior to study.
- Use of additional prescription medications, street drugs, or alcohol during the week before the study.
- Currently pregnant or lactating.
- History of significant cognitive decline
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of California, Irvine
Irvine, California, 92697
Weill Cornell Medical College
New York, New York, 10065
Stanford University, Department of Psychiatry and Behavioral Sciences
Stanford, California, 94305
About this study
The primary objective of this study is to investigate the biological components of major depression. The investigators are particularity interested in genetic variation and how it contributes to cortisol (because cortisol is higher in severe depression than mild depression or healthy controls) and how it contributes to clinical symptoms, especially suicidal ideation/behavior and psychosis.
- Conditions
- Major Depressive Disorder
- Medical subject headings
- Depressive Disorder, Major
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 |
|---|---|---|
| Major Depressive Disorder | Not described | |
| Healthy Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetics
Blood will be drawn for gene expression, which includes genetics and metallothionein assessments. Blood will also be drawn for later assay of immune function/measures and neurotophins, and for future studies.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study startJul 2013
- Primary completionAug 2020
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Cornell University, University of California, Irvine, Pritzker Consortium
- Responsible party
- Principal investigator, Alan Schatzberg, Stanford University
- Investigators
- Alan Schatzberg, M.D., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01831882
- Sponsor's protocol ID
- 26529
- Status last verified
- Aug 2020
- First submitted
- 9 Apr 2013
- Last updated
- 21 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Biological Markers for Severe Depression
- ClinicalTrials.gov ID
- NCT01831882
- Acronym / sponsor ID
- 26529
- Conditions
- Major Depressive Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Cornell University, University of California, Irvine, Pritzker Consortium
- Study start
- Jul 2013 (actual)
- Primary completion
- Aug 2020 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 15 Apr 2013 (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.
The primary objective of this study is to investigate the biological components of major depression. The investigators are particularity interested in genetic variation and how it contributes to cortisol (because cortisol is higher in severe depression than mild depression or healthy controls) and how it contributes to clinical symptoms, especially suicidal ideation/behavior and psychosis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Major Depressive Disorder | – | – |
| Healthy Control | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatient hospitals, outpatient clinics, community.
Key inclusion criteria (9 listed)
- Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) diagnosis of Unipolar Major Depressive Disorder with or without psychotic features.
- 21-item Hamilton Depression Rating Scale (HDRS) score greater than or equal to 21.
- Thase Core Endogenomorphic Scale score greater than or equal to 8 on the items included in the 21-item HDRS.
- Between 18 - 70 years of age.
- If currently taking antipsychotic, antidepressant, anticonvulsant, and/or mood-stabilizing medications, must be stable on the medication for at least one-week prior to entering the study.
Key exclusion criteria (15 listed)
- Electroconvulsive Therapy (ECT) in the 6 months prior to the study.
- Abuse of drugs or alcohol in the 6 months prior to study.
- Unstable or untreated hypertension or cardiovascular disease.
- Use of additional prescription medications, street drugs, or alcohol during the week before the study.
- Any Axis II diagnosis or traits which would make participation in the study difficult.
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
Genetics
Time frame: 1 year
Blood will be drawn for gene expression, which includes genetics and metallothionein assessments. Blood will also be drawn for later assay of immune function/measures and neurotophins, and for future studies.
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 21 Aug 2020.
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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.
Alan Schatzberg, M.D. principal investigator
Stanford University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, run by Stanford University at 3 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 9 inclusion and 15 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 21 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Genetics (time frame: 1 year). 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 21 Aug 2020.