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Completed

NCT Number: NCT02026622

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

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Tours

Tours, 37044, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

psychometric tests

Behavioral

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

MRI

Device

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

transcranial doppler and TPI

Device

transcranial doppler TPI

Other names: Tissue Pulsatility Imaging

explicitative interview

Behavioral

Primary outcomes

  1. amplitude variations of heart and respiratory rate, cerebral pulsatility, galvanic skin response and startle as measure of physiological reactivity

    Time frame: one day

    amplitude variations of heart and respiratory rate, cerebral pulsatility, galvanic skin response and startle.

Secondary outcomes

  1. MRI data as measure of cerebral perfusion, volume of leukoaraiosis and default network (fMRI at rest)

    Time frame: one day

    cerebral perfusion measured by MRI (Arterial Spin Labelling) volume of leukoaraiosis default network (fMRI at rest)

  2. ultrasound data of doppler as measure of cerebral pulstility

    Time frame: one day

    doppler index of middle cerebral artery At the same time, heart rate variability and cerebral pulsatility at rest will be collected

  3. score of psychometric tests as measure of emotional state

    Time frame: one day

    MADRS score, ERD score, STAI-E score, anhedonia score, Neo-PI score, and the subjective assessment of emotional arousal (self Manikin assessment).

  4. spontaneous verbal production to emotional pictures and explicitative interviews

    Time frame: one day

    spontaneous verbal production to emotional pictures and explicitative interviews

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: EMPHILINE

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 3, 2014
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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