Actively Recruiting

Phase Not Applicable
Age: 18Years - 39Years
All Genders
Healthy Volunteers
NCT07239791

Role of the Noradrenergic System in the Regulation of Learning Dynamics: Evaluation of the Effect of a Low-dose Selective Noradrenaline Reuptake Inhibitor (NOISYXETINE)

Led by Centre Hospitalier St Anne · Updated on 2025-11-20

160

Participants Needed

1

Research Sites

106 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

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)

Who Can Participate

Age: 18Years - 39Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Right-handed, assessed by the Edinburgh scale
  • Signed written informed consent
  • Covered by a social security regimen
  • Aged between 18 and 39 years
Not Eligible

You will not qualify if you...

  • Pregnant, parturient, or breastfeeding women
  • First-degree family history of axis I disorder (except unipolar mood and anxiety disorders with OCD)
  • Personal history of axis I disorder in the past 6 months
  • Dependence on psychoactive substances (excluding nicotine) in the past 12 months
  • Behavioral disorders incompatible with 2-hour EEG recording
  • Ongoing or recent (less than 1 month) neuro/psychotropic treatment
  • Personal history of neurological disease (e.g., CNS tumors, epilepsy, degenerative diseases)
  • Chronic diseases including infectious, neoplastic, vascular, immune, inflammatory, metabolic, endocrine, degenerative, or genetic disorders
  • Known high blood pressure or measured BP >140/90 mm Hg at baseline
  • Congenital heart disease, ischemic heart disease, heart failure, heart rhythm disorders
  • Nephropathy, known liver disease, or conditions worsened by increased blood pressure
  • Medical treatment within 1 month before study entry (except effective contraception)
  • Subject deprived of liberty by judicial or administrative decision
  • Subject under legal protection or unable to provide consent
  • Known intolerance to atomoxetine
  • Need to wear glasses or contact lenses to obtain normal vision
  • Currently enrolled in an exclusion period or another interventional study

AI-Screening

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Trial Site Locations

Total: 1 location

1

Institut de Neuromodulation

Paris, France, 75014

Actively Recruiting

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Research Team

F

Florent Meyniel, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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Role of the Noradrenergic System in the Regulation of Learning Dynamics: Evaluation of the Effect of a Low-dose Selective Noradrenaline Reuptake Inhibitor (NOISYXETINE) | DecenTrialz