Major DepressionNCT00825799
Serum Markers as a Bioassay for Unipolar Depression
An observational study of Major Depression, run by Steward St. Elizabeth's Medical Center of Boston, Inc. at 1 site in United States.
Trial summary
The goal of the study is to validate a biomarker assay for unipolar depression based on serum proteins involved in inflammation, metabolism, and stress response. The study will compare patients with a current major depressive episode to individuals with no history of depression. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depression
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to May 2011
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects are recruited from the community by advertisement.
Who may be able to join
- Aged 18 to 60.
- Meets DSM-IV criteria for Unipolar Major Depression, either single or recurrent.
- 21 item Hamilton Depression rating scale score greater than 18.
- Capable of providing informed consent.
- Has an established residence and phone number.
Who cannot join
- Meets DSM-IV criteria for Bipolar Disorder, Schizophrenia, Schizoaffective disorder or other major Axis I Psychiatric disorders (except for depression and phobia per above).
- Addison's Disease, Cushing's Disease, or other known dysfunction of the HPA-cortisol axis.
- Rheumatoid arthritis, lupus, or other condition associated with increased inflammation.
- Regular use of non-steroidal anti-inflammatory medications, steroids, or other medications know to interact with the inflammatory process of the HPA axis.
- A medical condition or regular use of a mediation, which I the opinion of the investigator is likely to influence the inflammatory or HPA responses.
- Pregnancy.
Show all 9Show fewer
- Meets DSM-IV criteria for substance abuse or dependence in the last month.
- Regular cigarette smoking.
- History of fainting or other significant adverse event during blood drawing in the past.
Trial locations and contacts
1 site in 1 country.
United States1 site
Steward St. Elizabeth's Medical Center
Boston, Massachusetts, 02135
About this study
Official title: Validation of Serum Markers as a Bioassay for Unipolar Depression
The goal of the study is to validate a biomarker assay for unipolar depression based on serum proteins involved in inflammation, metabolism, and stress response. The study will compare patients with a current major depressive episode to individuals with no history of depression. The hypothesis is that the assay can serve as a diagnostic tool that would be more objective than standard diagnostic questionnaires.
- Conditions
- Major Depression
- Keywords
- biomarker, depression, blood test
- Medical subject headings
- Depressive Disorder, Major, Depression
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 | Adults with major depressive disorder who are experiencing a current depressive episode. | |
| Healthy controls | Individuals without any Axis I psychiatric diagnosis who are matched to depressed subjects by age and sex. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein biomarker MDDScore.
Measured: 0 weeks
Secondary outcomes (1)
Score on Hamilton Depression Rating Scale (HDRS).
Measured: 0 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2009 (estimated)
- Study startNov 2007
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steward St. Elizabeth's Medical Center of Boston, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Ridge Diagnostics Inc.
- Responsible party
- Sponsor
- Investigators
- Michael E. Henry, MD, Principal investigator, Steward St. Elizabeth's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00825799
- Sponsor's protocol ID
- 00435
- Status last verified
- Jun 2013
- First submitted
- 19 Jan 2009
- Last updated
- 3 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Serum Markers as a Bioassay for Unipolar Depression
- ClinicalTrials.gov ID
- NCT00825799
- Acronym / sponsor ID
- 00435
- Conditions
- Major Depression
- Keywords
- biomarker, depression, blood test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Steward St. Elizabeth's Medical Center of Boston, Inc.University, hospital or other
- Collaborators
- Ridge Diagnostics Inc.
- Study start
- Nov 2007
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 21 Jan 2009 (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 goal of the study is to validate a biomarker assay for unipolar depression based on serum proteins involved in inflammation, metabolism, and stress response. The study will compare patients with a current major depressive episode to individuals with no history of depression. The hypothesis is that the assay can serve as a diagnostic tool that would be more objective than standard diagnostic questionnaires.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Major Depressive Disorder | – | –Adults with major depressive disorder who are experiencing a current depressive episode. |
| Healthy controls | – | –Individuals without any Axis I psychiatric diagnosis who are matched to depressed subjects by age and sex. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects are recruited from the community by advertisement.
Key inclusion criteria (5 listed)
- Aged 18 to 60.
- Meets DSM-IV criteria for Unipolar Major Depression, either single or recurrent.
- 21 item Hamilton Depression rating scale score greater than 18.
- Capable of providing informed consent.
- Has an established residence and phone number.
Key exclusion criteria (9 listed)
- Meets DSM-IV criteria for Bipolar Disorder, Schizophrenia, Schizoaffective disorder or other major Axis I Psychiatric disorders (except for depression and phobia per above).
- Addison's Disease, Cushing's Disease, or other known dysfunction of the HPA-cortisol axis.
- Rheumatoid arthritis, lupus, or other condition associated with increased inflammation.
- Regular use of non-steroidal anti-inflammatory medications, steroids, or other medications know to interact with the inflammatory process of the HPA axis.
- A medical condition or regular use of a mediation, which I the opinion of the investigator is likely to influence the inflammatory or HPA responses.
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
Protein biomarker MDDScore.
Time frame: 0 weeks
1 secondary outcome
Score on Hamilton Depression Rating Scale (HDRS).
Time frame: 0 weeks
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 3 Jan 2014.
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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.
Michael E. Henry, MD principal investigator
Steward St. Elizabeth's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depression, run by Steward St. Elizabeth's Medical Center of Boston, Inc. at 1 site 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 5 inclusion and 9 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 3 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Protein biomarker MDDScore. (time frame: 0 weeks). 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 3 Jan 2014.