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

Major Depression Clinical Trial

— CORVAD  

Official title:

Medial Prefrontal Cortex and Vulnerability for Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02171923
• Other study ID #: P110139
• Status: Completed
• Phase: N/A
• First received: September 17, 2013
• Last updated: October 5, 2015
• Start date: May 2013
• Est. completion date: July 2015

Study information

• Verified date: October 2015
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: ANSM-The French National Agency for Medicines and Health Products Safety
• Study type: Observational

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Case Control

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Locations

Country	Name	City	State
France	URC - HEGP, 20 rue Leblanc	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	18 month	No
Secondary	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.	1 year	No