Major Depressive DisorderEMPHILINENCT02026622
Comparative Study of Physiological and Cerebrovascular Reactivity in Depression, at the Three Phases of Emotion
A study testing psychometric tests, MRI and transcranial doppler and TPI in people with Major Depressive Disorder, run by University Hospital, Tours at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- psychometric tests, MRI and transcranial doppler and TPI
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2013to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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, ...)
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- contra-indication to MRI
- uncorrected vision or audition troubles
- patient under juridic protection
- pregnancy, lactating or female without reliable contraception
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Major Depressive Disorder
- Being tested
- psychometric tests, MRI, transcranial doppler and TPI, explicitative interview
- Keywords
- major depressive disorder, cerebrovascular reactivity, emotional reactivity
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychometric testsBehavioural
NEO-PI, MADRS, MINI depression, MMSE, STAI-E, ERD, Anhedonia
MRIDevice
ASL, rest f-MRI, FLAIR, white matter hyper intensities load
transcranial doppler and TPIDevice
Also called Tissue Pulsatility Imaging
transcranial doppler TPI
explicitative interviewBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: psychometric tests; Device: MRI; Device: transcranial doppler and TPI; Behavioral: explicitative interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one day
Secondary outcomes (4)
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)
Measured: one day
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
Measured: one day
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).
Measured: one day
spontaneous verbal production to emotional pictures and explicitative interviews
spontaneous verbal production to emotional pictures and explicitative interviews
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2014 (estimated)
- Study startFeb 2013
- Primary completionMay 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02026622
- Sponsor's protocol ID
- PHAO 2012 - TD / EMPHILINE
- Acronym
- EMPHILINE
- Status last verified
- Aug 2015
- First submitted
- 29 Oct 2013
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32761564
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Physiological and Cerebrovascular Reactivity in Depression, at the Three Phases of Emotion
- ClinicalTrials.gov ID
- NCT02026622
- Acronym / sponsor ID
- EMPHILINE / PHAO 2012 - TD / EMPHILINE
- Conditions
- Major Depressive Disorder
- Keywords
- major depressive disorder, cerebrovascular reactivity, emotional reactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 3 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3 groups of subjects | Other | Behavioral: psychometric tests, Device: MRI, Device: transcranial doppler and TPI, Behavioral: explicitative interview3 groups: depressive subjects, subjects remitted from depression and control subjects, with the same interventions. psychometric tests, MRI, transcranial doppler and TPI, explicitative interview |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| psychometric testsNEO-PI, MADRS, MINI depression, MMSE, STAI-E, ERD, Anhedonia | Behavioural | 3 groups of subjects |
| MRIASL, rest f-MRI, FLAIR, white matter hyper intensities load | Device | 3 groups of subjects |
| transcranial doppler and TPIAlso: Tissue Pulsatility Imagingtranscranial doppler TPI | Device | 3 groups of subjects |
| explicitative interview | Behavioural | 3 groups of subjects |
Primary outcome
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.
4 secondary outcomes
MRI data as measure of cerebral perfusion, volume of leukoaraiosis and default network (fMRI at rest)
Time frame: one day
ultrasound data of doppler as measure of cerebral pulstility
Time frame: one day
score of psychometric tests as measure of emotional state
Time frame: one day
spontaneous verbal production to emotional pictures and explicitative interviews
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Results publication: PubMed 32761564Siragusa 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychometric tests, MRI and transcranial doppler and TPI in people with Major Depressive Disorder, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amplitude variations of heart and respiratory rate, cerebral pulsatility, galvanic skin response and startle as measure of physiological reactivity (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02026622, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.