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

N/ACompletedNCT02171923

Assistance Publique - Hôpitaux de Paris77 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Major Depression

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

URC - HEGP, 20 rue Leblanc

Paris, France

Outcomes

Primary Outcomes

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.

Time frame: 18 month

Secondary Outcomes

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.

Time frame: 1 year

Data from ClinicalTrials.gov

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