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

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 Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Behavioral: psychometric tests; Device: MRI; Device: transcranial doppler and TPI; Behavioral: explicitative interview

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Tours, France, 37044
    • University Hospital of Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Behavioral: psychometric tests; NEO-PI, MADRS, MINI depression, MMSE, STAI-E, ERD, Anhedonia; Device: MRI; ASL, rest f-MRI, FLAIR, white matter hyper intensities load; Device: transcranial doppler and TPI; transcranial doppler TPI; Other Names: Tissue Pulsatility Imaging; Behavioral: explicitative interview

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
amplitude variations of heart and respiratory rate, cerebral pulsatility, galvanic skin response and startle as measure of physiological reactivity	amplitude variations of heart and respiratory rate, cerebral pulsatility, galvanic skin response and startle.	one day

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Tours

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: October 29, 2013
• First Submitted That Met QC Criteria: December 31, 2013
• First Posted (Estimate): January 3, 2014

Study Record Updates

• Last Update Posted (Estimate): September 1, 2015
• Last Update Submitted That Met QC Criteria: August 31, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: major depressive disorder; cerebrovascular reactivity; emotional reactivity
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: PHAO 2012 - TD / EMPHILINE