Status:
TERMINATED
Major Depressive Disorder: Early Prediction of Non-response to Antidepressant Therapy Via a Mobile Digital Scale
Lead Sponsor:
Ad scientiam
Conditions:
Depressive Disorder, Major
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Major Depressive Disorder (MDD) is a debilitating disease characterized by a depressed mood, diminished interests, impaired cognitive function and vegetative symptoms, such as disturbed sleep or appet...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
October 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 29 2022
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT03872492
Start Date
October 17 2019
End Date
December 29 2022
Last Update
March 3 2023
Active Locations (10)
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1
CHU Clermont-Ferrand
Clermont-Ferrand, France
2
CHU Grenoble
Grenoble, France
3
CHU Nantes - CAPPA Jacques Prévet
Nantes, France
4
CHU de Nice
Nice, France