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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
psychometric tests
MRI
transcranial doppler and TPI
explicitative interview
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Major Depressive Disorder focused on measuring major depressive disorder, cerebrovascular reactivity, emotional reactivity

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts 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

Sites / Locations

  • University Hospital of Tours

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

3 groups of subjects

Arm 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
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
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).
spontaneous verbal production to emotional pictures and explicitative interviews
spontaneous verbal production to emotional pictures and explicitative interviews

Full Information

First Posted
October 29, 2013
Last Updated
August 31, 2015
Sponsor
University Hospital, Tours
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1. Study Identification

Unique Protocol Identification Number
NCT02026622
Brief Title
Comparative Study of Physiological and Cerebrovascular Reactivity in Depression, at the Three Phases of Emotion
Acronym
EMPHILINE
Official Title
Comparative Study of Physiological and Cerebrovascular Reactivity in Depression, at the Three Phases of Emotion
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
major depressive disorder, cerebrovascular reactivity, emotional reactivity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3 groups of subjects
Arm Type
Other
Arm 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
Intervention Type
Behavioral
Intervention Name(s)
psychometric tests
Intervention Description
NEO-PI, MADRS, MINI depression, MMSE, STAI-E, ERD, Anhedonia
Intervention Type
Device
Intervention Name(s)
MRI
Intervention Description
ASL, rest f-MRI, FLAIR, white matter hyper intensities load
Intervention Type
Device
Intervention Name(s)
transcranial doppler and TPI
Other Intervention Name(s)
Tissue Pulsatility Imaging
Intervention Description
transcranial doppler TPI
Intervention Type
Behavioral
Intervention Name(s)
explicitative interview
Primary Outcome Measure Information:
Title
amplitude variations of heart and respiratory rate, cerebral pulsatility, galvanic skin response and startle as measure of physiological reactivity
Description
amplitude variations of heart and respiratory rate, cerebral pulsatility, galvanic skin response and startle.
Time Frame
one day
Secondary Outcome Measure Information:
Title
MRI data as measure of cerebral perfusion, volume of leukoaraiosis and default network (fMRI at rest)
Description
cerebral perfusion measured by MRI (Arterial Spin Labelling) volume of leukoaraiosis default network (fMRI at rest)
Time Frame
one day
Title
ultrasound data of doppler as measure of cerebral pulstility
Description
doppler index of middle cerebral artery At the same time, heart rate variability and cerebral pulsatility at rest will be collected
Time Frame
one day
Title
score of psychometric tests as measure of emotional state
Description
MADRS score, ERD score, STAI-E score, anhedonia score, Neo-PI score, and the subjective assessment of emotional arousal (self Manikin assessment).
Time Frame
one day
Title
spontaneous verbal production to emotional pictures and explicitative interviews
Description
spontaneous verbal production to emotional pictures and explicitative interviews
Time Frame
one day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
University Hospital of Tours
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

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

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