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

Not Applicable

Completed

• Conditions: Major Depressive Disorder
• Interventions: Behavioral: psychometric tests; Device: MRI; Device: transcranial doppler and TPI; Behavioral: explicitative interview

• Registration Number: NCT02026622
• Lead Sponsor: University Hospital, Tours

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-10-29
• Study First Submitted QC: 2013-12-31
• Study First Posted: 2014-01-03
• Primary Completion: 2015-05
• Status Verified: 2015-08
• Study Completion: 2015-08
• Last Update Submitted: 2015-08-31
• Last Update Posted: 2015-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
amplitude variations of heart and respiratory rate, cerebral pulsatility, galvanic skin response and startle as measure of physiological reactivity	one day	amplitude variations of heart and respiratory rate, cerebral pulsatility, galvanic skin response and startle.

Secondary Outcome Measures

Name	Time	Method
score of psychometric tests as measure of emotional state	one day	MADRS score, ERD score, STAI-E score, anhedonia score, Neo-PI score, and the subjective assessment of emotional arousal (self Manikin assessment).
MRI data as measure of cerebral perfusion, volume of leukoaraiosis and default network (fMRI at rest)	one day	cerebral perfusion measured by MRI (Arterial Spin Labelling) volume of leukoaraiosis default network (fMRI at rest)
ultrasound data of doppler as measure of cerebral pulstility	one day	doppler index of middle cerebral artery At the same time, heart rate variability and cerebral pulsatility at rest will be collected
spontaneous verbal production to emotional pictures and explicitative interviews	one day	spontaneous verbal production to emotional pictures and explicitative interviews

Trial Locations

Locations (1)

University Hospital of Tours; 🇫🇷 Tours, France