Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-24 @ 3:15 PM
NCT ID:
NCT03872492
Eligibility Criteria:
Inclusion Criteria:
* 18 to 70 Years
* Diagnostic and Statistical Manual of Mental Disorders-5 criteria for MDD
* Score \> 21 on HDRS-17
* Initiation of an antidepressant treatment for the current episode (first line or second line treatment, ...)
* Ability to use a mobile application
* Agreement to use the study mobile if he/she does not own an iPhone 5 or newer
* Enrolled in or benefiting of a Social Security program
* Having read the information sheet and signed the informed consent form
Non inclusion Criteria:
* Serious suicidal risk, identified by the Mini International Neuropsychiatric Interview (MINI)
* Perinatal depression
* Seasonal affective disorder
* Psychiatric comorbidities: bipolar disorder, obsessive-compulsive disorder, post-traumatic stress, psychotic disorder, anorexia nervosa, bulimia nervosa, personality disorder identified by the MINI questionnaire
* Alcohol addiction or abuse, identified by the MINI questionnaire
* Substance related disorders non-alcoholic addiction or abuse (opioids, cocaine, cannabis, sedatives, stimulants, hallucinogens, inhalants, solvents), identified by the MINI questionnaire
* Under neurostimulation (\< 6 months before inclusion day)
* Patient under Temporary Use Authorisation (TUA)
* Patients with Monoamine Oxidase Inhibitor (MAOIs), tricyclic antidepressant
* Patient with electroconvulsive therapy (ECT) history for current episode
* Patient with a somatic pathology
* Scheduled hospitalization for more than 7 days
* Antecedent of major head trauma
* Seizures
* Systemic medical diseases that are likely to affect cognitive functioning
* Pregnant and nursing women
* Wearers of pacemakers, implantable defibrillators
* Subjects not proficient in French
* Person under guardianship or curators
* Illiterate subjects
* Participation to another interventional clinical trial (category 1)
Exclusion criteria:
* Serious suicidal risk, according to clinician's judgement
* Discontinuation or change of AD treatment before 4 weeks after the dose initiation in the phase 1 and 2
* Initiation of a structured psychotherapy or neurostimulation
* Initiation of treatment with MAOIS
* Introduction of benzodiazepines at regular doses. Limited use (≤7 consecutive days or several periods of ≤3 consecutive days) is authorized
* Alcohol and substances abuse related disorders (opioids, cocaine, cannabis, sedatives, stimulants, hallucinogens, inhalants, solvents), according to clinician's judgement.
* Patient under Temporary Use Authorisation (TUA)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03872492
Study Brief:
Protocol Section:
NCT03872492