Depression Disorder
Conditions
Keywords
Depression, controllability, serotonin, SSRI, estimation of control
Brief 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. 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.
Interventions
DRUGSelective Serotonin Reuptake Inhibitors (SSRIs) or serotonergic antidepressants
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.
OTHERExperimental tasks
Experimental tasks assessing cognition, decision-making, and perceived controllability.
Sponsors
Hôpital le Vinatier
INSERM U1028
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Controllability Estimation Bias in depressed patients | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Controllability Estimation Bias in Depressed Patients vs Healthy Controls | 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 |
Countries
France
Contacts
CONTACTRomain Ligneul, PhD
CONTACTMéline Devaluez, PhD
PRINCIPAL_INVESTIGATORRomain Ligneul, PhD
Institut National de la Santé Et de la Recherche Médicale, France
Outcome results
None listed