Major Depressive Disorder Clinical Trial
— EMPHILINEOfficial title:
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.
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
France | University Hospital of Tours | Tours |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Tours |
France,
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 |
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