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

Major Depressive Disorder Clinical Trial

— EMPHILINE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02026622
• Other study ID #: PHAO 2012 - TD / EMPHILINE
• Status: Completed
• Phase: N/A
• First received: October 29, 2013
• Last updated: August 31, 2015
• Start date: February 2013
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: August 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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
• transcranial doppler and TPI
transcranial doppler TPI

Behavioral:
• explicitative interview

Locations

Country	Name	City	State
France	University Hospital of Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	spontaneous verbal production to emotional pictures and explicitative interviews	spontaneous verbal production to emotional pictures and explicitative interviews	one day	No