Major DepressionCORVADNCT02171923
Multicenter Comparative Study of the Activity of the Medial Prefrontal Cortex in Vulnerability to Depression
An observational study of Major Depression, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
To examine whether the medial prefrontal cortex displays an increased activity during self-referential processing among remitted depressed patients compared to healthy controls Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depression
- How many people
- 77 participants
- Where
- 1 siteFrance
- Study dates
- May 2013to Jul 2015
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Formerly depressed patients and healthy controls matched for age and sex
Who may be able to join
- History of at least one major depressive episode
- In clinical remission for at least 6 months (BDI-21 ≤ 10 \& Montgomery and Asberg Depression Rating Scale ≤ 7)
- Aged 20-65
Who cannot join
- first depressive episode after the age of 59
- last episode treated by cognitive behavior therapy
- currently receiving a antipsychotic or mood-stabilizing drug
- personal history of: major depressive episode with psychotic features, other axis-I disorder (except generalized anxiety disorder), substance-related disorder (except nicotine dependence), bipolar disorder
- first-degree familial history of bipolar disorder
- cognitive impairment due to another central nervous system disease
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- contra-indication to MRI
- pregnancy
- refusal to be informed of abnormal findings during the MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medial Prefrontal Cortex and Vulnerability for Depression
To examine whether the medial prefrontal cortex displays an increased activity during self-referential processing among remitted depressed patients compared to healthy controls
- Conditions
- Major Depression
- Keywords
- depression
- 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 |
|---|---|---|
| Remitted depressed patients | Formerly depressed patients in remission for 6 months or more | |
| healthy controls | healthy subjects with no history of mental disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOLD signal in the medial prefrontal cortex
Each subject will have a standardized psychometric assessment (BDI-21, MADRS, STAI, RRS) in a Siemens 3T Trio for collecting voxel BOLD signal (Blood-Oxygen-Level Dependent). For each subject and each voxel, a coefficient beta relative activation will be obtained with a general linear model using the timing of presentation of stimuli and the expected signal to model the measured hemodynamic BOLD response. A main effect of condition (personal versus general) will be sought to determine the peak activation within the dorsal CMPF (defined region of interest using the Pickatlas software). The primary endpoint will be the beta coefficient on the level of activation of a sphere 10 mm in diameter centered on the peak.
Measured: 18 month
Secondary outcomes (1)
depression relapse
The presence (MINI) and intensity (BDI) for possible depressive relapse will be sought from the attending psychiatrist and during telephone interviews at 6 and 12 months.
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 posted24 Jun 2014 (estimated)
- Study startMay 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cédric Lemogne, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02171923
- Sponsor's protocol ID
- P110139
- Acronym
- CORVAD
- Status last verified
- Oct 2015
- First submitted
- 17 Sep 2013
- Last updated
- 6 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lemogne C, Delaveau P, Freton M, Guionnet S, Fossati P. Medial prefrontal cortex and the self in major depression. J Affect Disord. 2012 Jan;136(1-2):e1-e11. doi: 10.1016/j.jad.2010.11.034. Epub 2010 Dec 23.
PubMed 21185083
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medial Prefrontal Cortex and Vulnerability for Depression
- ClinicalTrials.gov ID
- NCT02171923
- Acronym / sponsor ID
- CORVAD / P110139
- Conditions
- Major Depression
- Keywords
- depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 24 Jun 2014 (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.
To examine whether the medial prefrontal cortex displays an increased activity during self-referential processing among remitted depressed patients compared to healthy controls
Study design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remitted depressed patients | – | –Formerly depressed patients in remission for 6 months or more |
| healthy controls | – | –healthy subjects with no history of mental disorders |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Formerly depressed patients and healthy controls matched for age and sex
Key inclusion criteria (3 listed)
- History of at least one major depressive episode
- In clinical remission for at least 6 months (BDI-21 ≤ 10 \& Montgomery and Asberg Depression Rating Scale ≤ 7)
- Aged 20-65
Key exclusion criteria (9 listed)
- first depressive episode after the age of 59
- last episode treated by cognitive behavior therapy
- currently receiving a antipsychotic or mood-stabilizing drug
- personal history of: major depressive episode with psychotic features, other axis-I disorder (except generalized anxiety disorder), substance-related disorder (except nicotine dependence), bipolar disorder
- first-degree familial history of bipolar disorder
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
BOLD signal in the medial prefrontal cortex
Time frame: 18 month
Each subject will have a standardized psychometric assessment (BDI-21, MADRS, STAI, RRS) in a Siemens 3T Trio for collecting voxel BOLD signal (Blood-Oxygen-Level Dependent). For each subject and each voxel, a coefficient beta relative activation will be obtained with a general linear model using the timing of presentation of stimuli and the expected signal to model the measured hemodynamic BOLD response. A main effect of condition (personal versus general) will be sought to determine the peak activation within the dorsal CMPF (defined region of interest using the Pickatlas software). The primary endpoint will be the beta coefficient on the level of activation of a sphere 10 mm in diameter centered on the peak.
1 secondary outcome
depression relapse
Time frame: 1 year
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 6 Oct 2015.
- Background: PubMed 21185083Lemogne C, Delaveau P, Freton M, Guionnet S, Fossati P. Medial prefrontal cortex and the self in major depression. J Affect Disord. 2012 Jan;136(1-2):e1-e11. doi: 10.1016/j.jad.2010.11.034. Epub 2010 Dec 23.
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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.
Cédric Lemogne, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 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 6 Oct 2015. 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 France. 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?
BOLD signal in the medial prefrontal cortex (time frame: 18 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02171923, which also lists 1 linked publication.
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 6 Oct 2015.