ClinicalTrials.gg
TerminatedNCT03327974DEPASSEUpdated Sep 30, 2025

Evolution of Dark Ideas When Introducing or Switching an Antidepressant

An interventional study of DEPASSE Apllication in Current Major Depressive Disorder, sponsored by University Hospital, Montpellier. Terminated at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-09-30.

Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Other

Why this study was terminated
Problem on the app, questioned the feasability of the study
Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 126 studies in Depressive Disorder, Major with a site in France — 28 open to participants now, 30 under way, 2 of them phase 3. Depressive Disorder, Major · France.

Enrollment
93rd of 105
38 · median 230
Started
2017
with 8 others
No phase
49 of 126
19 open now
Registered
65th of 126
by date
Lead sponsor
7 of 126
University Hospital, Montpellier

Among the 126 studies in Depressive Disorder, Major with a site in France, this one is the 93rd largest by enrollment of the 105 interventional ones, is one of 9 that started in 2017, is one of 49 with no phase, and was the 65th registered.

By phase

126 studies; the count open now beside each. This study's row is marked.

No phasethis study49 · 19 open
Phase 336 · 2 open
Observational21 · 7 open
Phase 410 · 0 open
Phase 29 · 0 open
Phase 2/31 · 0 open

By the year they started

First in 2003; this study’s year is marked. 9 started in 2017.

Size and results

Median enrollment 230 across the 105 interventional studies, 128 across the 21 observational. Of the 84 that completed or were terminated, 31 (37%) have results posted.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Current Major Depressive Disorder

Keywords

  • Aged between 18 and 65
  • Major depressive disorder
  • Suicide
  • Ecological momentary assessment
  • Smartphone application
04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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
  • Able to understand the nature, purpose and methodology of the study
  • French language
  • Able to understand and conduct clinical assessments.

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
38 participants (actual)

Study arms

  • Other
    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

Interventions

  • OtherDEPASSE 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.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 1 month

Secondary outcomes

  1. 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)

    Time frame: 1 month

  2. 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)

    Time frame: 1 month

  3. 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)

    Time frame: 1 month

  4. 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)

    Time frame: 1 month

  5. 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)

    Time frame: 1 month

  6. 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)

    Time frame: 1 month

  7. 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)

    Time frame: 1 month

  8. 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)

    Time frame: 1 month

  9. 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)

    Time frame: 1 month

  10. Score at the Montgomery-Åsberg Depression Rating Scale (MADRS)

    Link between the self evaluation of the patient and the evaluation conducted by the psychiatrist

    Time frame: 1 month

  11. Score at the Columbia Suicide Severity Rating Scale (CSSRS)

    Link between the self evaluation of the patient and the evaluation conducted by the psychiatrist

    Time frame: 1 month

  12. Number of emergency room visits

    Link between the evolution of dark ideas over 1 month and the number of emergency room visits

    Time frame: 1 month

  13. Number of hospitalizations

    Link between the evolution of dark ideas over 1 month and the number hospitalizations

    Time frame: 1 month

  14. 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)

    Time frame: 1 month

07

Study locations

1 site
  • Uhmontpellier
    Montpellier, 34295, France
08

References and documents

Individual participant data

Plan to share: Undecided — NC

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2017 to primary completion in Dec 2018, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 27, 2017
First posted
Nov 1, 2017
StartActual
Nov 24, 2017
Primary completionActual
Dec 14, 2018
CompletionActual
Apr 9, 2019
Last update
Sep 30, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03327974
Responsible party
Sponsor
First posted
Nov 1, 2017
Start date
Nov 24, 2017
Primary completion
Dec 14, 2018
Completion
Apr 9, 2019
Last update
Sep 30, 2025

Study contacts

Lucile VILLAIN, MD
principal investigator · University Hospital, Montpellier

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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