Role of the Noradrenergic System in the Regulation of Learning DynamicsNOISYXETINENCT07239791
Role of the Noradrenergic System in the Regulation of Learning Dynamics: Evaluation of the Effect of a Low-dose Selective Noradrenaline Reuptake Inhibitor (NOISYXETINE)
A study testing Atomoxetine in people with Role of the Noradrenergic System in the Regulation of Learning Dynamics and No Disease or Condition is Being Studied, run by Centre Hospitalier St Anne at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Role of the Noradrenergic System in the Regulation of Learning Dynamics, No Disease or Condition is Being Studied
- What is being tested?
- Atomoxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 18 Nov 2025to Dec 2027
- 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 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Right-handed, assessed by the Edinburgh scale;
- Written signed informed consent;
- Subject covered by a social security regimen.
Who cannot join
- Pregnant, parturient or breastfeeding woman;
- First-degree family history of axis I disorder (DSM-IV-TR), excepted unipolar mood and anxiety disorders with OCD;
- Personal history of axis I disorder (DSM-IV-TR) in the 6 months preceding the study entry;
- Dependence on a psychoactive substance in the 12 months preceding the study entry, excluding nicotine, any behavioural disorder incompatible with a 2-hour electroencephalographic recording;
- Neuro/psychotropic treatment ongoing or stopped less than 1 month ago;
- Personal history of neurological pathology (e.g.: congenital malformation, benign or malignant tumour, degenerative disease of the central nervous system (CNS), epilepsy, inflammatory or infectious disease of the CNS, etc.);
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- Personal history of chronic disease of infectious, neoplastic, vascular, dysimmune or inflammatory, metabolic or endocrine, degenerative or genetic aetiology. In particular, angle-closure glaucoma, pheochromocytoma, known high blood pressure or measured blood pressure greater than 140/90 mm Hg at baseline, congenital heart disease, known ischemic heart disease, known heart failure, supraventricular or ventricular heart rhythm disorder, nephropathy, known liver disease and any pathology likely to be aggravated by an increase in blood pressure;
- Any medical treatment in the month preceding the study entry, apart from effective contraceptive treatment;
- Subject deprived of liberty by a judicial or administrative decision;
- Person subject to a legal protection measure or unable to express consent;
- Known intolerance to atomoxetine;
- Need to wear glasses and/or lenses to obtain normal vision;
- Subject in an exclusion period or enrolled in an interventional study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut de Neuromodulation
Paris, 75014
Cécile BULTEZ, MSc, +33 1 45 80 52 70 19, cecile.bultez@ghu-paris.fr
Philippe Domenech, MD, PhD
About this study
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.
Read more
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:
- Atomoxetine 40 mg - Placebo (Subgroups A1 or B1);
- Placebo - Atomoxetine 40 mg (Subgroups A2 or B2).
Read the detailed description
Hundred and sixty healthy volunteers will be enrolled (80 / task) in 24 months. The maximum duration of participation for each subject is 51 days.
- Conditions
- Role of the Noradrenergic System in the Regulation of Learning Dynamics, No Disease or Condition is Being Studied
- Being tested
- Atomoxetine, Placebo
- Keywords
- noradrenaline, learning dynamics, atomoxetine, healthy subject
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtomoxetineDrug
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)
PlaceboDrug
One single capsule of placebo given at one visit according to the sequence randomly allocated.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: Atomoxetine 40 mg - Placebo | Other | The participants will receive one cap of atomoxetine 40 mg at V1 and placebo at V2 Receives: Drug: Atomoxetine; Drug: Placebo |
| Sequence 2: Placebo - Atomoxetine 40 mg | Other | The participants will receive one cap of placebo at V1 and atomoxetine 40 mg at V2 Receives: Drug: Atomoxetine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Visit 1 (Day 0) to Visit 2 (Day 7)
Secondary outcomes (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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: From Visit 1 (Day 0) to Visit 2 (Day 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start18 Nov 2025
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Role of the Noradrenergic System in the Regulation of Learning DynamicsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier St AnneThe 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
- Randomised
- Intervention model
- Crossover
- Model description
- Single centre, double-blinded, randomized, placebo-controlled, cross-over study involving 160 evaluable healthy adults. Subjects will be separated in 2 cohorts: A for participants having the stable task and B for those having the changing one. They will then be randomized in a 1:1 ratio to one of the 2 treatment sequences: * Atomoxetine 40 mg - Placebo (Subgroups A1 or B1); * Placebo - Atomoxetine 40 mg (Subgroups A2 or B2).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239791
- Sponsor's protocol ID
- D24-P017
- Acronym
- NOISYXETINE
- Status last verified
- Nov 2025
- First submitted
- 29 Sep 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Noradrenergic System in the Regulation of Learning Dynamics: Evaluation of the Effect of a Low-dose Selective Noradrenaline Reuptake Inhibitor (NOISYXETINE)
- ClinicalTrials.gov ID
- NCT07239791
- Acronym / sponsor ID
- NOISYXETINE / D24-P017
- Conditions
- Role of the Noradrenergic System in the Regulation of Learning Dynamics, No Disease or Condition is Being Studied
- Keywords
- noradrenaline, learning dynamics, atomoxetine, healthy subject
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Study start
- 18 Nov 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 20 Nov 2025 (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.
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:
- Atomoxetine 40 mg - Placebo (Subgroups A1 or B1);
- Placebo - Atomoxetine 40 mg (Subgroups A2 or B2).
Detailed description
Hundred and sixty healthy volunteers will be enrolled (80 / task) in 24 months. The maximum duration of participation for each subject is 51 days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single centre, double-blinded, randomized, placebo-controlled, cross-over study involving 160 evaluable healthy adults. Subjects will be separated in 2 cohorts: A for participants having the stable task and B for those having the changing one. They will then be randomized in a 1:1 ratio to one of the 2 treatment sequences: * Atomoxetine 40 mg - Placebo (Subgroups A1 or B1); * Placebo - Atomoxetine 40 mg (Subgroups A2 or B2).
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: Atomoxetine 40 mg - Placebo | Other | Drug: Atomoxetine, Drug: PlaceboThe participants will receive one cap of atomoxetine 40 mg at V1 and placebo at V2 |
| Sequence 2: Placebo - Atomoxetine 40 mg | Other | Drug: Atomoxetine, Drug: PlaceboThe participants will receive one cap of placebo at V1 and atomoxetine 40 mg at V2 |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Right-handed, assessed by the Edinburgh scale;
- Written signed informed consent;
- Subject covered by a social security regimen.
Key exclusion criteria (13 listed)
- Pregnant, parturient or breastfeeding woman;
- First-degree family history of axis I disorder (DSM-IV-TR), excepted unipolar mood and anxiety disorders with OCD;
- Personal history of axis I disorder (DSM-IV-TR) in the 6 months preceding the study entry;
- Dependence on a psychoactive substance in the 12 months preceding the study entry, excluding nicotine, any behavioural disorder incompatible with a 2-hour electroencephalographic recording;
- Neuro/psychotropic treatment ongoing or stopped less than 1 month ago;
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 |
|---|---|---|
| AtomoxetineOne 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) | Drug | Sequence 1: Atomoxetine 40 mg - Placebo, Sequence 2: Placebo - Atomoxetine 40 mg |
| PlaceboOne single capsule of placebo given at one visit according to the sequence randomly allocated. | Drug | Sequence 1: Atomoxetine 40 mg - Placebo, Sequence 2: Placebo - Atomoxetine 40 mg |
Primary outcome
Apparent Learning rate
Time frame: From Visit 1 (Day 0) to Visit 2 (Day 7)
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.
7 secondary outcomes
Number of adverse events
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)
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
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
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
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
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
Time frame: From Visit 1 (Day 0) to Visit 2 (Day 7)
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 20 Nov 2025.
- Individual participant dataSharing planned: Yes
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atomoxetine in people with Role of the Noradrenergic System in the Regulation of Learning Dynamics and No Disease or Condition is Being Studied, run by Centre Hospitalier St Anne 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 3 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 20 Nov 2025. 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 Florent Meyniel, MD, PhD (+33 1 45 65 63 90, florent.meyniel@ghu-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apparent Learning rate (time frame: From Visit 1 (Day 0) to Visit 2 (Day 7)). 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 20 Nov 2025.