Clinical trial NCT03327974: Evolution of Dark Ideas When Introducing or Switching an Antidepressant
Official title: Evolution of Dark Ideas When Introducing or Switching an Antidepressant: Hetero-evaluation and Use of a Smartphone Application in the Monitoring of Depression
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Current Major Depressive Disorder
Keywords: Aged between 18 and 65
Major depressive disorder
Suicide
Ecological momentary assessment
Smartphone application
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2017-11-01
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Depression is a frequent disease and a serious public health problem, of which suicide is the most severe complication. Its treatment is based on the introduction of antidepressant which not only proposes a significant delay in the relief of symptoms but also by the phenomenon of lifting of inhibition can increase the suicidal risk during the initiation phase. Therefore there is a major interest in proposing a monitoring of these dark and suicidal ideas, immediately after the implementation of such treatment as well as other symptoms of depression. Thus, the aim of this study is to identify the mechanisms underlying this increase in dark and suicidal ideas in this context.

Detailed description: The study propose to assess, with an ecological momentary assessment method, the evolution of black ideas over 30 days following the introduction or switch of an oral antidepressants.

103 patients will be recruited suffering from a current major depressive disorder in the Montpellier University Hospital.

Each patient will attend a total of 3 scheduled visits, which will be completed over a period of 1 month (inclusion, between 10-15 days, 1 month. During this month, the patient will have to complete daily assesments throught a smartphone application "Depasse".

This Servier application allows the daily monitoring of symptoms allowing a regular evaluation, in the form of smileys simulating a Likert type scale evaluation of 1 to 5.

10 parameters are evaluated: moral, black thoughts, sleep, stress, concentration, social activities, energy, pleasure, motivation and libido. Note that when the patient expresses dark thoughts, he is then asked if he wants to hurt himself. If he answers yes, he is then asked to contact an emergency service.

One of its originalities is the addition of positive psychology approaches with a positive reinforcement of this evaluation through reward by a smiley in a smiley box and obtaining a "pleasant" image for motivation and incentive.

There is the possibility to have the graphical follow-up of the various parameters and to send them by mail to his treating psychiatrist.

Advice adapted to the mood of the day is provided taking into account the "dysfunctional" parameters.

Similarly, the emergency buoy tool provides access to emergency numbers and directs the patient to seek care.

Intelligence of the weight and the treatments established. The app also has a notification setting to remind the patient to evaluate themselves daily.

Eligibility criteria: Inclusion criteria:

* Subject aged 18 to 65
* Diagnosis of a characterized depressive episode assessed by the clinician
* Depression score : MADRS\> 20
* Introduction or switch of an antidepressant (without combination of molecules)
* Signed informed consent
* Able to understand the nature, purpose and methodology of the study
* French language
* Able to understand and conduct clinical assessments.

Exclusion criteria:

* The following psychiatric comorbidities: Bipolar disorder, schizophrenia, alcohol dependence and / or any other substance objectivized during the clinical evaluation
* Patient presenting a depressive episode characterized with mixed component, psychotic, melancholic or catatonic characteristics
* Score MADRS greater than or equal to 5 to one of the items
* Subject protected by law (guardianship or curatorship)
* Subject in exclusion period from another protocol
* Subject not affiliated to, or not beneficiary of, a social security scheme
* Pregnant orbreastfeeding patient

Primary outcomes:
measure: Values of dark ideas assessed with a Likert type scale [1;5]
timeFrame: 1 month
Secondary outcomes:
measure: Values of the actual mood assessed with a Lickert type scale [1;5]
timeFrame: 1 month
measure: Values of the actual motivation assessed with a Lickert type scale [1;5]
timeFrame: 1 month
measure: Values of the ability to feel pleasure as usual assessed with a Lickert type scale [1;5]
timeFrame: 1 month
measure: Values of the energy assessed with a Lickert type scale [1;5]
timeFrame: 1 month
measure: Values of the social activities assessed with a Lickert type scale [1;5]
timeFrame: 1 month
measure: Values of the concentration assessed with a Lickert type scale [1;5]
timeFrame: 1 month
measure: Values of the stress assessed with a Lickert type scale [1;5]
timeFrame: 1 month
measure: Values of the libido assessed with a Lickert type scale [1;5]
timeFrame: 1 month
measure: Values of sleep assessed with a Lickert type scale [1;5]
timeFrame: 1 month
measure: Score at the Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: 1 month
measure: Score at the Columbia Suicide Severity Rating Scale (CSSRS)
timeFrame: 1 month
measure: Number of emergency room visits
timeFrame: 1 month
measure: Number of hospitalizations
timeFrame: 1 month
measure: Satisfaction score on the Lickert type scale [1;5]
timeFrame: 1 month
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Lucile VILLAIN, MD
role: PRINCIPAL_INVESTIGATOR
References: