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Multicenter Comparative Study of the Activity of the Medial Prefrontal Cortex in Vulnerability to Depression (CORVAD)

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ClinicalTrials.gov Identifier: NCT02171923
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : October 6, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
To examine whether the medial prefrontal cortex displays an increased activity during self-referential processing among remitted depressed patients compared to healthy controls

Condition or disease
Major Depression

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Study Type : Observational
Actual Enrollment : 77 participants
Observational Model: Case Control
Official Title: Medial Prefrontal Cortex and Vulnerability for Depression
Study Start Date : May 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Group/Cohort
Remitted depressed patients
Formerly depressed patients in remission for 6 months or more
healthy controls
healthy subjects with no history of mental disorders



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. depression relapse [ Time Frame: 1 year ]
    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.



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Formerly depressed patients and healthy controls matched for age and sex
Criteria

Inclusion criteria (patients)

  • 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

Exclusion criteria :

  • 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
  • contra-indication to MRI
  • pregnancy
  • refusal to be informed of abnormal findings during the MRI

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02171923


Locations
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France
URC - HEGP, 20 rue Leblanc
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Cédric Lemogne, MD, PhD Assistance Publique - Hôpitaux de Paris

Publications:
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02171923     History of Changes
Other Study ID Numbers: P110139
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: October 6, 2015
Last Verified: October 2015
Keywords provided by Assistance Publique - Hôpitaux de Paris:
depression
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders