An interventional study of Atomoxetine and Placebo in Role of the Noradrenergic System in the Regulation of Learning Dynamics and No Disease or Condition is Being Studied, sponsored by Centre Hospitalier St Anne. Recruiting at 1 site in France. Open to participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-20.
Sponsored by Centre Hospitalier St Anne · Not applicable, Interventional, and Basic science
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Administration of low-dose selective noradrenaline reuptake inhibitor (sNRI) (e.g. atomoxetine) to healthy subjects is a validated model of increasing cortical noradrenaline levels which, combined with computational modelling of behaviour, allows fine-grained analysis of the impact on learning processes of noradrenaline's fluctuations in the human cortex.
The study goal is to characterize the modifications of certain cognitive processes and associated brain circuits under low-dose sNRI using validated computational learning models. The study will be interested in how subjects will modify their learning under the effect of the drug across two separate investigations; one utilizing in a stable evidence accumulation task and one utilising a changing evidence accumulation task. This approach will help to better understand the link between noradrenaline and accumulation of evidence in healthy subjects, and indirectly in some neuropsychiatric pathologies.
The study is a single centre, double-blinded, randomized, placebo-controlled, cross-over study involving evaluable healthy adults separated in 2 cohorts: A for participants having the stable task and B for those having the changing one. Participants will then be randomized in a 1:1 ratio to one of the following treatment sequences:
Hundred and sixty healthy volunteers will be enrolled (80 / task) in 24 months. The maximum duration of participation for each subject is 51 days.
Centre Hospitalier St Anne is the lead sponsor of 101 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The participants will receive one cap of atomoxetine 40 mg at V1 and placebo at V2
Drug: Atomoxetine · Drug: Placebo
The participants will receive one cap of placebo at V1 and atomoxetine 40 mg at V2
Drug: Atomoxetine · Drug: Placebo
One single capsule of atomoxetine 40 mg given at one visit according to the sequence randomly allocated. Placebo of atomoxetine will be administered at the other visit for the participant (according to the sequence randomly allocated)
One single capsule of placebo given at one visit according to the sequence randomly allocated.
Apparent Learning rate
Paired difference in the apparent learning rates (in both environmental contexts: stable task and changing task), between the sNRI (atomoxetine) and control (placebo) conditions. Apparent learning rate will be calculate with the following formula: αt=(vt- vt-(1) )/(xt- vt-1) according to Foucault and Meyniel (Foucault C, Meyniel F (2024) Two Determinants of Dynamic Adaptive Learning for Magnitudes and Probabilities. Open Mind : Discov Cogn Sci 8:615-638) The learning rate measures the amount of update of the learned value (from vt-(1 to vt) induced by the observation xt in proportion to its deviation from the previously learned value.
Time frame: From Visit 1 (Day 0) to Visit 2 (Day 7)
Number of adverse events
Side effects (treatment related adverse events) in all groups between study drug administration at Visit 1 (Day 0) and Visit 2 (Day 7) including vital signs worsening and ECG findings
Time frame: From Visit 1 (Day 0) to Visit 2 (Day 7)
Change from Visit 1 (Day 0) in the computational modelling of behaviour at Visit 2 (Day 7)
Computational modelling of behaviour at Visit 1 and 2: paired difference in latent behavioral parameters of the computational models that characterize the learning process (in a stable accumulation task and in a dynamic accumulation task), between the sNRI (atomoxetine) and control (placebo) conditions.
Time frame: From Visit 1 (Day 0) to Visit 2 (Day 7)
Change from Visit 1 (Day 0) in the score of the State Trait Anxiety Inventory (STAI) questionnaire at Visit 2
The scores of the State Trait Anxiety Inventory (STAI) questionnaire (Spielberger et al., 1983) will be compared between Hour 0 and Hour 3 at Visit 1 and 2 to control for the effect of the substance on the subjects' levels of depression and anxiety. The STAI comprises 2 questionnaires of 20 items with the following ranges: * STAI-YA (state anxiety): 0-80 with 0 equivalent to no anxiety and 80 the worst possible anxiety * STAI-YB (Trait anxiety): 0-80 with 0 equivalent to no anxiety and 80 the worst possible anxiety
Time frame: From Visit 1 (Day 0) to Visit 2 (Day 7)
Change from Visit 1 (Day 0) in the score of the Beck Depression Inventory (BDI) questionnaire at Visit 2
The scores of the Beck Depression Inventory (BDI) questionnaire (Beck et al., 1961) will be compared between Hour 0 and Hour 3 at Visit 1 and Visit 2 to control for the effect of the substance on the subjects' levels of depression. The BDI comprises 21 items with the following ranges: 0-63 with 0 equivalent to no depression and 63 the worst possible depression.
Time frame: From Visit 1 (Day 0) to Visit 2 (Day 7)
Change from Visit 1 (Day 0) in the score of visual analogue scale (VAS) on anxiety at Visit 2
The scores of the VAS-anxiety will be compared between Hour 0 and Hour 3 at Visit 1 and Visit 2 to control for the effect of the substance on the subjects' levels of anxiety. The VAS ranges from 0 (no anxiety) to 100 mm (worst possible anxiety).
Time frame: From Visit 1 (Day 0) to Visit 2 (Day 7)
Change from Visit 1 (Day 0) in the score of visual analogue scale (VAS) on sadness at Visit 2
The scores of the VAS-sadness will be compared between Hour 0 and Hour 3 at Visit 1 and Visit 2 to control for the effect of the substance on the subjects' levels of sadness. The VAS ranges from 0 (no sadness) to 100 mm (worst possible sadness).
Time frame: From Visit 1 (Day 0) to Visit 2 (Day 7)
Change from Visit 1 (Day 0) in the score of visual analogue scale (VAS) on fatigue at Visit 2
The scores of the VAS-fatigue will be compared between Hour 0 and Hour 3 at Visit 1 and Visit 2 to control for the effect of the substance on the subjects' levels of fatigue. The VAS ranges from 0 (no fatigue) to 100 mm (maximum imaginable fatigue).
Time frame: From Visit 1 (Day 0) to Visit 2 (Day 7)
Plan to share: Yes
Supporting information: Analytic code
Data sharing details ↗ · www.osf.io
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Nov 2027, 24 months after the start.
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Studies of the drug tested here: Atomoxetine