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Completed

NCT Number: NCT02171923

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

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

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Key information

Conditions

Major Depression Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

URC - HEGP, 20 rue Leblanc

Paris, 75015, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Medial Prefrontal Cortex and Vulnerability for Depression

Acronym: CORVAD

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 24, 2014
Registry last updated
Oct 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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