Current Major Depressive DisorderDEPASSENCT03327974
Evolution of Dark Ideas When Introducing or Switching an Antidepressant
A study testing DEPASSE Apllication in people with Current Major Depressive Disorder, run by University Hospital, Montpellier at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Current Major Depressive Disorder
- What is being tested?
- DEPASSE Apllication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 24 Nov 2017to 9 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Current Major Depressive Disorder
- Being tested
- DEPASSE Apllication
- Keywords
- Aged between 18 and 65, Major depressive disorder, Suicide, Ecological momentary assessment, Smartphone application
- Medical subject headings
- Depressive Disorder, Major, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEPASSE ApllicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| depressed patients | Other | All patients performed the same evaluation : ecological momentary assesement throught smartphone and 3 sheduled visits.
All patients are depressed patients. Receives: Other: DEPASSE Apllication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 month
Secondary outcomes (14)
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)
Measured: 1 month
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)
Measured: 1 month
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)
Measured: 1 month
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)
Measured: 1 month
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)
Measured: 1 month
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)
Measured: 1 month
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)
Measured: 1 month
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)
Measured: 1 month
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)
Measured: 1 month
Score at the Montgomery-Åsberg Depression Rating Scale (MADRS)
Link between the self evaluation of the patient and the evaluation conducted by the psychiatrist
Measured: 1 month
Score at the Columbia Suicide Severity Rating Scale (CSSRS)
Link between the self evaluation of the patient and the evaluation conducted by the psychiatrist
Measured: 1 month
Number of emergency room visits
Link between the evolution of dark ideas over 1 month and the number of emergency room visits
Measured: 1 month
Number of hospitalizations
Link between the evolution of dark ideas over 1 month and the number hospitalizations
Measured: 1 month
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)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start24 Nov 2017
- Primary completion14 Dec 2018
- Study completion9 Apr 2019
Why it stopped: Problem on the app, questioned the feasability of the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Current Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucile VILLAIN, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327974
- Sponsor's protocol ID
- RECHMPL17_0137
- Acronym
- DEPASSE
- Status last verified
- Sep 2025
- First submitted
- 27 Oct 2017
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03327974
- Acronym / sponsor ID
- DEPASSE / RECHMPL17_0137
- Conditions
- Current Major Depressive Disorder
- Keywords
- Aged between 18 and 65, Major depressive disorder, Suicide, Ecological momentary assessment, Smartphone application
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Problem on the app, questioned the feasability of the study
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 24 Nov 2017 (actual)
- Primary completion
- 14 Dec 2018 (actual)
- Study completion
- 9 Apr 2019 (actual)
- First posted
- 1 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| depressed patients | Other | Other: DEPASSE ApllicationAll patients performed the same evaluation : ecological momentary assesement throught smartphone and 3 sheduled visits. All patients are depressed patients. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DEPASSE ApllicationApplication 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. | Other | depressed patients |
Primary outcome
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)
14 secondary outcomes
Values of the actual mood assessed with a Lickert type scale [1;5]
Time frame: 1 month
Values of the actual motivation assessed with a Lickert type scale [1;5]
Time frame: 1 month
Values of the ability to feel pleasure as usual assessed with a Lickert type scale [1;5]
Time frame: 1 month
Values of the energy assessed with a Lickert type scale [1;5]
Time frame: 1 month
Values of the social activities assessed with a Lickert type scale [1;5]
Time frame: 1 month
Values of the concentration assessed with a Lickert type scale [1;5]
Time frame: 1 month
Values of the stress assessed with a Lickert type scale [1;5]
Time frame: 1 month
Values of the libido assessed with a Lickert type scale [1;5]
Time frame: 1 month
Values of sleep assessed with a Lickert type scale [1;5]
Time frame: 1 month
Score at the Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: 1 month
Score at the Columbia Suicide Severity Rating Scale (CSSRS)
Time frame: 1 month
Number of emergency room visits
Time frame: 1 month
Number of hospitalizations
Time frame: 1 month
Satisfaction score on the Lickert type scale [1;5]
Time frame: 1 month
Results and safety
The study was stopped early (reason given: Problem on the app, questioned the feasability of the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: Undecided. NC
Related trials for Current Major Depressive Disorder
Recruiting
Closed-Loop Transcranial Alternating Current Stimulation for the Treatment of Major Depressive Disorder
Depression - Major Depressive Disorder, Transcranial Alternating Current Stimulation
Active, not recruiting
Accelerated Intermittent Theta-Burst Stimulation (aiTBS) in Treatment-Resistant Depression of Bipolar II Disorder
Bipolar II Disorder, Most Recent Episode Major Depressive, Current Depressive Episode
Active, not recruiting
Home-Based CR and tDCS to Enhance Cognition in Persons With Mild Cognitive Impairment and Late Life Depression
Mild Cognitive Impairment, Major Depressive Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucile VILLAIN, MD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DEPASSE Apllication in people with Current Major Depressive Disorder, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Problem on the app, questioned the feasability of the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Values of dark ideas assessed with a Likert type scale [1;5] (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025; AzTrials last refreshed its copy on 2 Nov 2026.