Evolution of Dark Ideas When Introducing or Switching an Antidepressant (DEPASSE)

• ClinicalTrials.gov Identifier: NCT03327974
• Recruitment Status: Terminated
• First Posted: November 1, 2017
• Last Update Posted: December 31, 2020
• Sponsor: University Hospital, Montpellier
• Information provided by (Responsible Party): University Hospital, Montpellier

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Current Major Depressive Disorder	Other: DEPASSE Apllication	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 38 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Actual Study Start Date: November 24, 2017
• Actual Primary Completion Date: December 14, 2018
• Actual Study Completion Date: April 9, 2019

Arms and Interventions

Arm

Intervention/treatment

depressed patients; All patients performed the same evaluation : ecological momentary assesement throught smartphone and 3 sheduled visits. All patients are depressed patients.

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.

Outcome Measures

Primary Outcome Measures :

1. Values of dark ideas assessed with a Likert type scale [1;5] [ Time Frame: 1 month ]
   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)

Secondary Outcome Measures :

1. Values of the actual mood assessed with a Lickert type scale [1;5] [ Time Frame: 1 month ]
   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)
2. Values of the actual motivation assessed with a Lickert type scale [1;5] [ Time Frame: 1 month ]
   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)
3. Values of the ability to feel pleasure as usual assessed with a Lickert type scale [1;5] [ Time Frame: 1 month ]
   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)
4. Values of the energy assessed with a Lickert type scale [1;5] [ Time Frame: 1 month ]
   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)
5. Values of the social activities assessed with a Lickert type scale [1;5] [ Time Frame: 1 month ]
   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)
6. Values of the concentration assessed with a Lickert type scale [1;5] [ Time Frame: 1 month ]
   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)
7. Values of the stress assessed with a Lickert type scale [1;5] [ Time Frame: 1 month ]
   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)
8. Values of the libido assessed with a Lickert type scale [1;5] [ Time Frame: 1 month ]
   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)
9. Values of sleep assessed with a Lickert type scale [1;5] [ Time Frame: 1 month ]
   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)
10. Score at the Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 1 month ]
    Link between the self evaluation of the patient and the evaluation conducted by the psychiatrist
11. Score at the Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: 1 month ]
    Link between the self evaluation of the patient and the evaluation conducted by the psychiatrist
12. Number of emergency room visits [ Time Frame: 1 month ]
    Link between the evolution of dark ideas over 1 month and the number of emergency room visits
13. Number of hospitalizations [ Time Frame: 1 month ]
    Link between the evolution of dark ideas over 1 month and the number hospitalizations
14. Satisfaction score on the Lickert type scale [1;5] [ Time Frame: 1 month ]
    Assessment of the patient satisfaction regarding the utilization of DEPASSE, from 1 (= not at all) to 5 (= absolutely)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

France

Uhmontpellier

Montpellier, France, 34295

Sponsors and Collaborators

University Hospital, Montpellier

Investigators

• Principal Investigator: Lucile VILLAIN, MD; University Hospital, Montpellier

More Information

• Responsible Party: University Hospital, Montpellier
• ClinicalTrials.gov Identifier: NCT03327974
• Other Study ID Numbers: UF9829
• First Posted: November 1, 2017
• Last Update Posted: December 31, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: NC

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Montpellier:

Aged between 18 and 65; Major depressive disorder; Suicide; Ecological momentary assessment; Smartphone application

Additional relevant MeSH terms:

Depressive Disorder; Depression; Depressive Disorder, Major; Mood Disorders; Mental Disorders; Behavioral Symptoms