NCT02026622

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable major-depressive-disorder

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 3, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

December 26, 2025

Status Verified

August 1, 2015

Enrollment Period

2.2 years

First QC Date

October 29, 2013

Last Update Submit

December 18, 2025

Conditions

Major Depressive Disorder

Keywords

major depressive disordercerebrovascular reactivityemotional reactivity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

  • score of psychometric tests as measure of emotional state

    one day

  • spontaneous verbal production to emotional pictures and explicitative interviews

    one day

Study Arms (1)

3 groups of subjects

OTHER

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 testsDevice: MRIDevice: transcranial doppler and TPIBehavioral: explicitative interview

Interventions

psychometric testsBEHAVIORAL

NEO-PI, MADRS, MINI depression, MMSE, STAI-E, ERD, Anhedonia

3 groups of subjects
MRIDEVICE

ASL, rest f-MRI, FLAIR, white matter hyper intensities load

3 groups of subjects
transcranial doppler and TPIDEVICE

transcranial doppler TPI

Also known as: Tissue Pulsatility Imaging
3 groups of subjects
explicitative interviewBEHAVIORAL
3 groups of subjects

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Tours

Tours, 37044, France

Location

Related Publications (1)

  • Siragusa MA, Rufin T, Courtois R, Belzung C, Andersson F, Brizard B, Dujardin PA, Cottier JP, Patat F, Remenieras JP, Gissot V, El-Hage W, Camus V, Desmidt T. Left amygdala volume and brain tissue pulsatility are associated with neuroticism: an MRI and ultrasound study. Brain Imaging Behav. 2021 Jun;15(3):1499-1507. doi: 10.1007/s11682-020-00348-w.

    PMID: 32761564RESULT

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

PsychometricsUltrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and ActivitiesEchoencephalographyNeuroradiographyNeuroimagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographyUltrasonographyUltrasonography, DopplerDiagnostic Techniques, NeurologicalInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2013

First Posted

January 3, 2014

Study Start

February 1, 2013

Primary Completion

May 1, 2015

Study Completion

August 1, 2015

Last Updated

December 26, 2025

Record last verified: 2015-08

Locations

FR(1)