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

Medial Prefrontal Cortex and Vulnerability for Depression

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02171923

Acronym

CORVAD

Enrollment

Registered

2014-06-24

Start date

2013-05-31

Completion date

2015-07-31

Last updated

2015-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depression

Keywords

depression

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
BOLD signal in the medial prefrontal cortex	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

Measure	Time frame	Description
depression relapse	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.

Countries

France

Outcome results