Low-dose atomoxetine to see how noradrenaline changes learning and decision-making

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

This study will test whether a low dose of atomoxetine changes how healthy adults learn and update decisions during tasks that measure evidence accumulation.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years to 39 Years
• Sex: All
• Sponsor: Centre Hospitalier St Anne (Academic / other)
• Locations: 1 site (Paris)
• Trial ID: NCT07239791 on ClinicalTrials.gov

What this trial studies

Healthy, right-handed volunteers receive either a low dose of the selective noradrenaline reuptake inhibitor atomoxetine or placebo while performing two types of evidence-accumulation tasks (one stable, one changing). Behavioral choices and timing are modeled with validated computational learning algorithms to characterize how increased cortical noradrenaline affects learning dynamics. The single-center study plans to enroll 160 participants (about 80 per task) over 24 months, with a maximum individual participation of 51 days. Data will link pharmacological manipulation, task performance, and modeled learning parameters to identify noradrenergic influences on neural circuits of decision-making.

Who should consider this trial

Good fit: Ideal candidates are healthy, right-handed adults who can provide informed consent, are covered by a social security regimen, are not pregnant or breastfeeding, have no recent axis I psychiatric disorder or recent psychotropic treatment, and have no significant neurological or chronic medical conditions.

Not a fit: People with current or recent psychiatric or neurological disorders, dependence on psychoactive substances within the past year (except nicotine), recent psychotropic medication use, pregnant or breastfeeding women, or those unable to undergo EEG recordings would not be expected to benefit from participating.

Why it matters

Potential benefit: If successful, the results could clarify how noradrenaline shapes learning and decision processes and help refine treatments for neuropsychiatric conditions involving noradrenergic dysfunction.

How similar studies have performed: Previous studies have used low-dose atomoxetine in healthy volunteers to probe noradrenergic effects on cognition, though combining this pharmacological challenge with fine-grained computational modeling of evidence-accumulation tasks is a more recent application.

Eligibility criteria

Inclusion Criteria:

* Right-handed, assessed by the Edinburgh scale;
* Written signed informed consent;
* Subject covered by a social security regimen.

Exclusion Criteria:

* 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.);
* 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.

Where this trial is running

Paris

• Institut de Neuromodulation — Paris, France (Recruiting)

Study contacts

• Study coordinator: Florent Meyniel, MD, PhD

Conditions Role of the Noradrenergic System in the Regulation of Learning Dynamics; No Disease or Condition is Being Studied; noradrenaline; learning dynamics; atomoxetine; healthy subject