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

University Hospital, Tours1 site in 1 country76 target enrollmentFebruary 1, 2013

ConditionsMajor Depressive Disorder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Major Depressive Disorder
Sponsor: University Hospital, Tours
Enrollment: 76
Locations: 1
Primary Endpoint: amplitude variations of heart and respiratory rate, cerebral pulsatility, galvanic skin response and startle as measure of physiological reactivity
Status: Completed
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

February 1, 2013

End Date

August 1, 2015

Last Updated

4 months ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

University Hospital, Tours

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

amplitude variations of heart and respiratory rate, cerebral pulsatility, galvanic skin response and startle as measure of physiological reactivity

Time Frame: one day

amplitude variations of heart and respiratory rate, cerebral pulsatility, galvanic skin response and startle.

Secondary Outcomes

score of psychometric tests as measure of emotional state(one day)
MRI data as measure of cerebral perfusion, volume of leukoaraiosis and default network (fMRI at rest)(one day)
ultrasound data of doppler as measure of cerebral pulstility(one day)
spontaneous verbal production to emotional pictures and explicitative interviews(one day)