Depression DisorderAPTE-SeroNCT07716982
Estimation of Control Before and After Treatment of a Depressive Episode With Serotonin Reuptake Inhibitors
A study testing Selective Serotonin Reuptake Inhibitors (SSRIs) or serotonergic antidepressants and Experimental tasks in people with Depression Disorder, run by Hôpital le Vinatier at 1 site in France.
Trial summary
The goal of this observational study is to better understand cognitive and affective processes involved in depression, in particular how individuals estimate their perception of control over events in their environment, as well as related processes such as memory and decision-making. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression Disorder
- What is being tested?
- Selective Serotonin Reuptake Inhibitors (SSRIs) or serotonergic antidepressants and Experimental tasks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2026to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Affiliated with a social security or national health insurance system, or entitled to such coverage.
- Male or female, aged 18 to 55 years.
- Fluent in spoken and written French.
- Normal or corrected-to-normal vision.
- Access to a computer and an internet connection.
- Available for the 8-week study period following treatment initiation (patients) or the baseline visit (healthy controls).
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- Willing to use an effective method of contraception (condom, oral contraceptive pill, abstinence, or intrauterine device).
- Additional inclusion criteria for the depressed patient group:
- Eligible for antidepressant monotherapy with a selective serotonin reuptake inhibitor (SSRI: sertraline, fluoxetine, citalopram, or paroxetine) or a serotonin-norepinephrine reuptake inhibitor (SNRI: venlafaxine or duloxetine), with or without concomitant treatment with a short half-life benzodiazepine (<12 hours; e.g., oxazepam, lorazepam, or clotiazepam), for which the prescription has been issued but treatment has not yet been initiated.
- Montgomery-Åsberg Depression Rating Scale (MADRS) score >6 and <35 (corresponding to mild-to-moderate depression), assessed during the routine clinical visit with the treating physician.
- No evidence of suicidal ideation, high-risk behaviors, history of suicide attempt, or overt psychotic symptoms that could compromise participant safety.
- No severe medical condition or unstable physiological state considered incompatible with study participation by the referring physician, including but not limited to unstable chronic diseases (e.g., hypertension or diabetes), respiratory insufficiency, cardiovascular insufficiency, or renal insufficiency.
Who cannot join
- History of a major depressive episode within the past 3 years.
- Use of antidepressants, mood stabilizers, or antipsychotic medication within the past 3 years.
- Diagnosis of a neurological or psychiatric disorder affecting central nervous system function (including bipolar disorder, schizophrenia, or other psychotic disorders according to DSM-5 criteria).
- Pregnancy or breastfeeding (self-reported).
- Individuals under legal protection (guardianship, curatorship, or judicial protection measures).
- Current participation in another interventional clinical trial or ongoing exclusion period following a previous clinical trial.
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- Planned initiation during the study of a medication or substance known to interfere with serotonergic activity (including MDMA, LSD, psilocybin, ketamine, cocaine, 5-HT2A receptor antagonist antipsychotics, triptans, or lithium).
- Use of serotonin-acting recreational drugs within the previous 6 months (including cocaine, MDMA, or psychedelic substances).
- Refusal to be informed of the potential discovery of a clinically significant incidental finding.
- Additional exclusion criteria for the depressed patient group
- Antidepressant treatment already initiated before study enrollment.
- Use of benzodiazepines within the 12 hours preceding an experimental session.
- Treatment with benzodiazepines other than oxazepam, lorazepam, or clotiazepam.
- Current hospitalization.
- Risk of suicidal behavior, defined as a score of ≥2 on the "zest for life" ("élan de vie") item of the Montgomery-Åsberg Depression Rating Scale (MADRS).
- Current treatment considered clinically incompatible with study participation by the physician responsible for recruitment.
- Additional exclusion criteria for the healthy volunteer group :
- Current or previous diagnosis of a depressive or anxiety disorder.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Méline Devaluez, PhD contact
France1 site
Centre de Recherche en Neuroscience de Lyon
Bron, 69500
Romain Ligneul, PhD, +33 04 72 13 89 00, romain.ligneul@inserm.fr
About this study
The goal of this observational study is to better understand cognitive and affective processes involved in depression, in particular how individuals estimate their perception of control over events in their environment, as well as related processes such as memory and decision-making. The study also aims to investigate how these processes are affected by antidepressant treatment and how depressive symptoms evolve over time, as well as whether specific peripheral markers (including hormones) are associated with treatment effects.
Read the detailed description
The main questions it aims to answer are:
How do individuals with a depressive episode differ from healthy controls in their estimation of control over environmental events? How does antidepressant treatment (selective serotonin reuptake inhibitors) influence perceived control, cognitive performance, and depressive symptoms over time? Are changes in perceived control and symptoms associated with biological markers measured during the study?
Researchers will compare participants with a current depressive episode to healthy control participants, and examine changes over time in the depressed group before and after treatment initiation, in order to assess the effects of antidepressant treatment on cognition, perceived control, and symptoms.
Participants will:
- Complete 4 study sessions over approximately 8 weeks, including 2 in-person visits at the Centre de Recherche en Neurosciences de Lyon (CRNL) and 2 online sessions.
- Complete questionnaires assessing depressive symptoms, personality traits, and life events.
- Perform computerized behavioral tasks involving prediction, learning, memory, and decision-making in virtual environments.
- Complete tasks designed to assess perceived control over outcomes in different contexts.
- Undergo non-invasive physiological recordings during in-person sessions, including eye-tracking, heart rate monitoring, and muscle activity measurement.
- Perform short online versions of the cognitive tasks between visits.
- Healthy control participants will complete the same procedures, except for antidepressant treatment exposure, while the depressed group will be followed over time before and after treatment.
- Conditions
- Depression Disorder
- Being tested
- Selective Serotonin Reuptake Inhibitors (SSRIs) or serotonergic antidepressants, Experimental tasks
- Keywords
- Depression, controllability, serotonin, SSRI, estimation of control
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective Serotonin Reuptake Inhibitors (SSRIs) or serotonergic antidepressantsDrug
Participants are prescribed serotonergic antidepressants such as fluoxetine, sertraline, escitalopram, paroxetine, or serotonin-norepinephrine reuptake inhibitor (SNRI). Dosage, formulation, frequency, and treatment duration are determined by the treating clinician. No experimental manipulation of medication is performed within the study. The intervention is characterized to assess its association with cognitive performance, reaction time (RT), accuracy, and controllability-related decision-making.
Experimental tasksOther
Experimental tasks assessing cognition, decision-making, and perceived controllability.
| Study group | Role | What they receive |
|---|---|---|
| Depression group | Experimental | Patients presenting a depressive episode and receiving serotonergic antidepressant treatment Receives: Drug: Selective Serotonin Reuptake Inhibitors (SSRIs) or serotonergic antidepressants; Other: Experimental tasks |
| Control group | Experimental | Healthy participants who are not receiving serotonergic antidepressant treatment. Receives: Other: Experimental tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Controllability Estimation Bias in depressed patients
normalization of the controllability estimation bias in patients with depression after 8 weeks of treatment with a selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI). The assessment of controllability is not obtained directly from the participant, but through a computational model inferred from their behavioural data (reaction time (RT), prediction accuracy (percentage of correct responses) and error rate)
Measured: Change between baseline and week 8
Secondary outcomes (1)
Controllability Estimation Bias in Depressed Patients vs Healthy Controls
This measure compares the controllability estimation bias between participants with a current depressive episode and healthy controls using a behavioral task assessing perceived control over environmental outcomes
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression DisorderStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM U1028
- Responsible party
- Sponsor
- Investigators
- Romain Ligneul, PhD, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07716982
- Sponsor's protocol ID
- 2026-A00663-48
- Acronym
- APTE-Sero
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Control Before and After Treatment of a Depressive Episode With Serotonin Reuptake Inhibitors
- ClinicalTrials.gov ID
- NCT07716982
- Acronym / sponsor ID
- APTE-Sero / 2026-A00663-48
- Conditions
- Depression Disorder
- Keywords
- Depression, controllability, serotonin, SSRI, estimation of control
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Collaborators
- INSERM U1028
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 21 Jul 2026 (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.
The goal of this observational study is to better understand cognitive and affective processes involved in depression, in particular how individuals estimate their perception of control over events in their environment, as well as related processes such as memory and decision-making. The study also aims to investigate how these processes are affected by antidepressant treatment and how depressive symptoms evolve over time, as well as whether specific peripheral markers (including hormones) are associated with treatment effects.
Detailed description
The main questions it aims to answer are:
How do individuals with a depressive episode differ from healthy controls in their estimation of control over environmental events? How does antidepressant treatment (selective serotonin reuptake inhibitors) influence perceived control, cognitive performance, and depressive symptoms over time? Are changes in perceived control and symptoms associated with biological markers measured during the study?
Researchers will compare participants with a current depressive episode to healthy control participants, and examine changes over time in the depressed group before and after treatment initiation, in order to assess the effects of antidepressant treatment on cognition, perceived control, and symptoms.
Participants will:
- Complete 4 study sessions over approximately 8 weeks, including 2 in-person visits at the Centre de Recherche en Neurosciences de Lyon (CRNL) and 2 online sessions.
- Complete questionnaires assessing depressive symptoms, personality traits, and life events.
- Perform computerized behavioral tasks involving prediction, learning, memory, and decision-making in virtual environments.
- Complete tasks designed to assess perceived control over outcomes in different contexts.
- Undergo non-invasive physiological recordings during in-person sessions, including eye-tracking, heart rate monitoring, and muscle activity measurement.
- Perform short online versions of the cognitive tasks between visits.
- Healthy control participants will complete the same procedures, except for antidepressant treatment exposure, while the depressed group will be followed over time before and after treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Depression group | Experimental | Drug: Selective Serotonin Reuptake Inhibitors (SSRIs) or serotonergic antidepressants, Other: Experimental tasksPatients presenting a depressive episode and receiving serotonergic antidepressant treatment |
| Control group | Experimental | Other: Experimental tasksHealthy participants who are not receiving serotonergic antidepressant treatment. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Affiliated with a social security or national health insurance system, or entitled to such coverage.
- Male or female, aged 18 to 55 years.
- Fluent in spoken and written French.
- Normal or corrected-to-normal vision.
- Access to a computer and an internet connection.
Key exclusion criteria (18 listed)
- History of a major depressive episode within the past 3 years.
- Use of antidepressants, mood stabilizers, or antipsychotic medication within the past 3 years.
- Diagnosis of a neurological or psychiatric disorder affecting central nervous system function (including bipolar disorder, schizophrenia, or other psychotic disorders according to DSM-5 criteria).
- Pregnancy or breastfeeding (self-reported).
- Individuals under legal protection (guardianship, curatorship, or judicial protection measures).
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 |
|---|---|---|
| Selective Serotonin Reuptake Inhibitors (SSRIs) or serotonergic antidepressantsParticipants are prescribed serotonergic antidepressants such as fluoxetine, sertraline, escitalopram, paroxetine, or serotonin-norepinephrine reuptake inhibitor (SNRI). Dosage, formulation, frequency, and treatment duration are determined by the treating clinician. No experimental manipulation of medication is performed within the study. The intervention is characterized to assess its association with cognitive performance, reaction time (RT), accuracy, and controllability-related decision-making. | Drug | Depression group |
| Experimental tasksExperimental tasks assessing cognition, decision-making, and perceived controllability. | Other | Control group, Depression group |
Primary outcome
Controllability Estimation Bias in depressed patients
Time frame: Change between baseline and week 8
normalization of the controllability estimation bias in patients with depression after 8 weeks of treatment with a selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI). The assessment of controllability is not obtained directly from the participant, but through a computational model inferred from their behavioural data (reaction time (RT), prediction accuracy (percentage of correct responses) and error rate)
1 secondary outcome
Controllability Estimation Bias in Depressed Patients vs Healthy Controls
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Méline Devaluez, PhD contact
Romain Ligneul, PhD principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective Serotonin Reuptake Inhibitors (SSRIs) or serotonergic antidepressants and Experimental tasks in people with Depression Disorder, run by Hôpital le Vinatier 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 12 inclusion and 18 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: opening soon, as of the sponsor's last update on 21 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Romain Ligneul, PhD (+33 04 72 13 89 00, romain.ligneul@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Controllability Estimation Bias in depressed patients (time frame: Change between baseline and week 8). 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 21 Jul 2026.