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Estimation of Control Before and After Treatment of a Depressive Episode With Serotonin Reuptake Inhibitors (APTE-Sero)

16 juli 2026 uppdaterad av: Hôpital le Vinatier
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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

124

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

  • Namn: Méline Devaluez, PhD
  • Telefonnummer: +33 04 37 91 55 14

Studieorter

      • Bron, Frankrike, 69500
        • Centre de Recherche en Neuroscience de Lyon
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Ja

Beskrivning

Inclusion Criteria - applicable to all participants:

  • 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).
  • 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.

Exclusion criteria applicable to all participants:

  • 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.
  • 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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Grundläggande vetenskap
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Depression group
Patients presenting a depressive episode and receiving serotonergic antidepressant treatment
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 tasks assessing cognition, decision-making, and perceived controllability.
Experimentell: Control group
Healthy participants who are not receiving serotonergic antidepressant treatment.
Experimental tasks assessing cognition, decision-making, and perceived controllability.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Controllability Estimation Bias in depressed patients
Tidsram: 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)
Change between baseline and week 8

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Controllability Estimation Bias in Depressed Patients vs Healthy Controls
Tidsram: Baseline
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
Baseline

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Samarbetspartners

Utredare

  • Huvudutredare: Romain Ligneul, PhD, Institut National de la Santé Et de la Recherche Médicale, France

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 september 2026

Primärt slutförande (Beräknad)

1 december 2029

Avslutad studie (Beräknad)

1 december 2029

Studieregistreringsdatum

Först inskickad

16 juli 2026

Först inskickad som uppfyllde QC-kriterierna

16 juli 2026

Första postat (Faktisk)

21 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

21 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 juli 2026

Senast verifierad

1 juli 2026

Mer information

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