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

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ClinicalTrials.gov Identifier: NCT03327974
Recruitment Status : Terminated (Problem on the app, questioned the feasability of the study)
First Posted : November 1, 2017
Last Update Posted : December 31, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

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.





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)



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03327974


Locations
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France
Uhmontpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Lucile VILLAIN, MD University Hospital, Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03327974    
Other Study ID Numbers: UF9829
First Posted: November 1, 2017    Key Record Dates
Last Update Posted: December 31, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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