Comparative Study of Physiological and Cerebrovascular Reactivity in Depression, at the Three Phases of Emotion
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Hospital, Tours
- Enrollment
- 76
- Locations
- 2
- Primary Endpoint
- amplitude variations of heart and respiratory rate, cerebral pulsatility, galvanic skin response and startle as measure of physiological reactivity
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
3 groups of subjects
3 groups: depressive subjects, subjects remitted from depression and control subjects, with the same interventions.
psychometric tests, MRI, transcranial doppler and TPI, explicitative interview
Intervention: psychometric tests (Behavioral)
3 groups of subjects
3 groups: depressive subjects, subjects remitted from depression and control subjects, with the same interventions.
psychometric tests, MRI, transcranial doppler and TPI, explicitative interview
Intervention: MRI (Device)
3 groups of subjects
3 groups: depressive subjects, subjects remitted from depression and control subjects, with the same interventions.
psychometric tests, MRI, transcranial doppler and TPI, explicitative interview
Intervention: transcranial doppler and TPI (Device)
3 groups of subjects
3 groups: depressive subjects, subjects remitted from depression and control subjects, with the same interventions.
psychometric tests, MRI, transcranial doppler and TPI, explicitative interview
Intervention: explicitative interview (Behavioral)
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)