Estimation of Control Before and After Treatment of a Depressive Episode With Serotonin Reuptake Inhibitors

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorHôpital le Vinatier

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Selective Serotonin Reuptake Inhibitors (SSRIs) or serotonergic antidepressants

    Drug

    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

    Other intervention

    Experimental tasks assessing cognition, decision-making, and perceived controllability.

Treatment groups

124 Participants
are divided into 2 treatment groups
Group A: Depression groupExperimental treatment 2 interventions
Group B: Control groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
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

Time frame
Baseline

Other outcomes

Sponsors and contacts

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Hôpital le Vinatier

Lead sponsor

INSERM U1028

Collaborator

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