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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Institut de Neuromodulation
  Paris, France Recruiting

Study contacts

• Study coordinator: Florent Meyniel, MD, PhD
• Email: florent.meyniel@ghu-paris.fr
• Phone: +33 1 45 65 63 90

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.