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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02026622
Acronym
EMPHILINE
Enrollment
76
Registered
2014-01-03
Start date
2013-02-28
Completion date
2015-08-31
Last updated
2025-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Keywords

major depressive disorder, cerebrovascular reactivity, emotional reactivity

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.

Interventions

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

DEVICEMRI

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

DEVICEtranscranial doppler and TPI

transcranial doppler TPI

BEHAVIORALexplicitative interview

Sponsors

University Hospital, Tours
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
amplitude variations of heart and respiratory rate, cerebral pulsatility, galvanic skin response and startle as measure of physiological reactivityone dayamplitude variations of heart and respiratory rate, cerebral pulsatility, galvanic skin response and startle.

Secondary

MeasureTime frameDescription
MRI data as measure of cerebral perfusion, volume of leukoaraiosis and default network (fMRI at rest)one daycerebral perfusion measured by MRI (Arterial Spin Labelling) volume of leukoaraiosis default network (fMRI at rest)
ultrasound data of doppler as measure of cerebral pulstilityone daydoppler 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 stateone dayMADRS 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 interviewsone dayspontaneous verbal production to emotional pictures and explicitative interviews

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026