DepressionNCT00178880
MRI Imaging of Chronobiologic Abnormalities in Depression
An observational study of Depression, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The purpose of the study is to identify and understand patterns of brain activity when people are depressed. The study will use an imaging method called Magnetic Resonance Imaging (MRI) which does not involve any exposure to radioactivity or radioactive substances. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Nov 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers and depressed patients.
Who may be able to join
- WEIGHT: less than or at 20% over ideal weight, as specified in the 1983 Metropolitan Height and Weight Tables. Patients who deviate from these ranges may be reviewed on an individual basis by the Investigator. This criterion is necessary because of mechanical limitations in fitting overweight individuals into the scanner, and the risk of excessive claustrophobic responses if tightly constricted.
- HEALTH: healthy, ambulatory normal or depressed adults
Who cannot join
- Presence of aneurysm clips, cardiac pacemakers, cochlear implants, metal in the eyes, and implanted insulin pumps.
- Evidence of significant hepatic, gastrointestinal, renal, respiratory, endocrine, hematologic, neurologic, psychiatric, or cardiovascular system abnormalities.
- Pregnancy.
- Patients with a known or suspected history of alcohol or drug misuse and/or a positive urine drug screen.
- Patients who are unwilling or unable to abide by the requirements of the study or who violate the prohibitions and restrictions of the study.
- Any condition which would make the patient, in the opinion of the Investigator, unsuitable for the study.
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- Patients on antidepressants may not be taking any other medication, except at the discretion of the investigator. Untreated depressed or healthy subjects must be free of all medications except as approved by the investigator.
- Patients with serious medical illness, history or signs/symptoms of lumbar spine/disc disease or significant laboratory findings.
- Patients who present significant suicide risk, e.g. with a history of highly impulsive suicide attempts.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37323
About this study
The purpose of the study is to identify and understand patterns of brain activity when people are depressed. The study will use an imaging method called Magnetic Resonance Imaging (MRI) which does not involve any exposure to radioactivity or radioactive substances.
Read the detailed description
The purpose of the study is to identify and understand patterns of brain activity when people are depressed. The study will use an imaging method called Magnetic Resonance Imaging (MRI) which does not involve any exposure to radioactivity or radioactive substances.
- Conditions
- Depression
- Keywords
- depression, MRI, imaging
- Medical subject headings
- 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 |
|---|---|---|
| Healthy volunteers | Not described | |
| Depressed patients | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startNov 2008
- Primary completionNov 2009
- Study completionNov 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 Vanderbilt University Medical CenterThe 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
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronald M Salomon, MD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00178880
- Sponsor's protocol ID
- 010242
- Status last verified
- Mar 2017
- First submitted
- 12 Sep 2005
- Last updated
- 4 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Imaging of Chronobiologic Abnormalities in Depression
- ClinicalTrials.gov ID
- NCT00178880
- Acronym / sponsor ID
- 010242
- Conditions
- Depression
- Keywords
- depression, MRI, imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Nov 2008 (actual)
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 15 Sep 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.
The purpose of the study is to identify and understand patterns of brain activity when people are depressed. The study will use an imaging method called Magnetic Resonance Imaging (MRI) which does not involve any exposure to radioactivity or radioactive substances.
Detailed description
The purpose of the study is to identify and understand patterns of brain activity when people are depressed. The study will use an imaging method called Magnetic Resonance Imaging (MRI) which does not involve any exposure to radioactivity or radioactive substances.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | – |
| Depressed patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers and depressed patients.
Key inclusion criteria (2 listed)
- WEIGHT: less than or at 20% over ideal weight, as specified in the 1983 Metropolitan Height and Weight Tables. Patients who deviate from these ranges may be reviewed on an individual basis by the Investigator. This criterion is necessary because of mechanical limitations in fitting overweight individuals into the scanner, and the risk of excessive claustrophobic responses if tightly constricted.
- HEALTH: healthy, ambulatory normal or depressed adults
Key exclusion criteria (9 listed)
- Presence of aneurysm clips, cardiac pacemakers, cochlear implants, metal in the eyes, and implanted insulin pumps.
- Evidence of significant hepatic, gastrointestinal, renal, respiratory, endocrine, hematologic, neurologic, psychiatric, or cardiovascular system abnormalities.
- Pregnancy.
- Patients with a known or suspected history of alcohol or drug misuse and/or a positive urine drug screen.
- Patients who are unwilling or unable to abide by the requirements of the study or who violate the prohibitions and restrictions of the study.
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
Not reported in the source record.
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 4 Apr 2017.
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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.
Ronald M Salomon, MD principal investigator
Vanderbilt University
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 Depression, run by Vanderbilt University Medical Center 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 2 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 4 Apr 2017. 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.
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 4 Apr 2017.