Evolution of Dark Ideas When Introducing or Switching an Antidepressant

Current Major Depressive Disorder Clinical Trial

— DEPASSE  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03327974
• Other study ID #: UF9829
• Status: Terminated
• Phase: N/A
• Start date: November 24, 2017
• Est. completion date: April 9, 2019

Study information

• Verified date: December 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: April 9, 2019
• Est. primary completion date: December 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Current Major Depressive Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Other:
• DEPASSE Apllication
Application DEPASSE in depressed patients. This application was developed by the laboratory SERVIER, by a scientific committee of psychologists and psychiatrists: Pr. Courtet, Dr Rimlinger and Pr. Swendsen. Depasse is available for all on the App store and on Googleplay. This application has several interests: - The first is the daily monitoring of the symptoms allowing a regular evaluation throught smileys simulating a scale from 1 to 5. The 10 parameters evaluated are: mood, dark ideas, sleep, stress, concentration, social activities, energy, pleasure, motivation and libido. There is the possibility to generate a graph representing the evolution of these parameters. Tips adapted to the actual mood are provided related to the "dysfunctional" parameters.

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Values of dark ideas assessed with a Likert type scale [1;5]	Evolution of dark ideas over 30 days. Throught the DEPASSE smartphone application, the patient assess the actual frequency of dark ideas from a Likert type scale of 1 (= not at all) to 5 (= often)	1 month
Secondary	Values of the actual mood assessed with a Lickert type scale [1;5]	Evolution of the mood over 30 days. Throught the DEPASSE smartphone application, the patient evaluates whether he/she is in a good mood from 1 (= not at all) to 5 (= absolutely)	1 month
Secondary	Values of the actual motivation assessed with a Lickert type scale [1;5]	Evolution of the mood over 30 days. Throught the DEPASSE smartphone application, the patient evaluates his/her motivation from 1 (= not at all) to 5 (= absolutely)	1 month
Secondary	Values of the ability to feel pleasure as usual assessed with a Lickert type scale [1;5]	Evolution of the mood over 30 days. Throught the DEPASSE smartphone application, the patient evaluates his/her the ability to feel pleasure as usual from 1 (= not at all) to 5 (= absolutely)	1 month
Secondary	Values of the energy assessed with a Lickert type scale [1;5]	Evolution of the mood over 30 days. Throught the DEPASSE smartphone application, the patient evaluates whether he/she feels energetic from 1 (= not at all) to 5 (= absolutely)	1 month
Secondary	Values of the social activities assessed with a Lickert type scale [1;5]	Evolution of the mood over 30 days. Throught the DEPASSE smartphone application, the patient assesses whether he or she is involved in social activities from 1 (= not at all) to 5 (= absolutely)	1 month
Secondary	Values of the concentration assessed with a Lickert type scale [1;5]	Evolution of the mood over 30 days. Throught the DEPASSE smartphone application, the patient assesses his/her ability to concentrate as usual from 1 (= not at all) to 5 (= absolutely)	1 month
Secondary	Values of the stress assessed with a Lickert type scale [1;5]	Evolution of the mood over 30 days. Throught the DEPASSE smartphone application, the patient assesses whether he feels relaxed from 1 (= not at all) to 5 (= absolutely)	1 month
Secondary	Values of the libido assessed with a Lickert type scale [1;5]	Evolution of the mood over 30 days. Throught the DEPASSE smartphone application, if the patient has the same libido as usual from 1 (= not at all) to 5 (= absolutely)	1 month
Secondary	Values of sleep assessed with a Lickert type scale [1;5]	Evolution of the mood over 30 days. Throught the DEPASSE smartphone application, if the patient sleep well from 1 (= not at all) to 5 (= absolutely)	1 month
Secondary	Score at the Montgomery-Åsberg Depression Rating Scale (MADRS)	Link between the self evaluation of the patient and the evaluation conducted by the psychiatrist	1 month
Secondary	Score at the Columbia Suicide Severity Rating Scale (CSSRS)	Link between the self evaluation of the patient and the evaluation conducted by the psychiatrist	1 month
Secondary	Number of emergency room visits	Link between the evolution of dark ideas over 1 month and the number of emergency room visits	1 month
Secondary	Number of hospitalizations	Link between the evolution of dark ideas over 1 month and the number hospitalizations	1 month
Secondary	Satisfaction score on the Lickert type scale [1;5]	Assessment of the patient satisfaction regarding the utilization of DEPASSE, from 1 (= not at all) to 5 (= absolutely)	1 month