Comparative Study of Physiological and Cerebrovascular Reactivity in Depression, at the Three Phases of Emotion (EMPHILINE)

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Major Depressive Disorder

Treatments: Device: MRI; Behavioral: explicitative interview; Device: transcranial doppler and TPI; Behavioral: psychometric tests

Study type: Interventional

Funder types: Other

Identifiers

NCT02026622

PHAO 2012 - TD / EMPHILINE

Details and patient eligibility

About

The main objective is to compare the physiological reactivity (heart and respiratory rates, galvanic skin response, cerebral perfusion, and startle) in the three phases of emotion between depressive subjects, subjects remitted from depression and control subjects.

Enrollment: 76 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female between 18 and 55
• Informed consent form signed
• Affiliated to a medical insurance
• visual and hearing abilities suitable for exams
• for the depressive group (group D): major depressive disorder according to the DSM-IV criteria as evaluated by the MINI test and MADRS score ≥22
• for the depressive patients in remission's group (group R) : matched on age, at least 1 history of major depressive disorder in the last 10 years and solved for more than 6 months, and MADRS score < 9
• for the control subjects (group T) : matched on age, no psychiatric history, MADRS score < 9

Exclusion criteria

• psychotic disorder, bipolar disorder, addiction, suspected dementia (MMSE<25)
• current betablockers or neuroleptics treatment
• any current organic unstable pathology
• history of serious cardiovascular disease (coronary syndrome, cardiac arrythmia, etc.)
• smoking > 10 PY
• history of serious neurologic disease (stroke, cerebral tumour, serious cranial trauma, headache, ...)
• contra-indication to MRI
• uncorrected vision or audition troubles
• patient under juridic protection
• pregnancy, lactating or female without reliable contraception

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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76 participants in 1 patient group

3 groups of subjects

Other group

Description:

3 groups: depressive subjects, subjects remitted from depression and control subjects, with the same interventions. psychometric tests, MRI, transcranial doppler and TPI, explicitative interview

Treatment:

Behavioral: psychometric tests

Device: transcranial doppler and TPI

Behavioral: explicitative interview

Device: MRI