Atomoxetine for Healthy volunteers

Inclusion criteria

• {"criterion_text":"- Age 18 to 39 years old"}
• {"criterion_text":"- Right-handed, assessed by the Edinburgh scale"}
• {"criterion_text":"- Written signed informed consent"}
• {"criterion_text":"- Subject covered by the social security system"}

Exclusion criteria

• {"criterion_text":"- Pregnant, parturient or breastfeeding woman"}
• {"criterion_text":"- Person subject to a legal protection measure or unable to express consent"}
• {"criterion_text":"- Known intolerance to atomoxetine"}
• {"criterion_text":"- Need to wear glasses and/or lenses to obtain normal vision"}
• {"criterion_text":"- Subject in an exclusion period or enrolled in an interventional study"}
• {"criterion_text":"- First-degree family history of axis I disorder (DSM-IV-TR), excepted unipolar mood and anxiety disorders with OCD"}
• {"criterion_text":"- Personal history of axis I disorder (DSM-IV-TR) in the 6 months preceding the study entry"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Neuro/psychotropic treatment ongoing or stopped less than 1 month ago"}
• {"criterion_text":"- 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.)"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Any medical treatment in the month preceding the study entry, apart from effective contraceptive treatment"}
• {"criterion_text":"- Subject deprived of liberty by a judicial or administrative decision"}

Primary endpoints

• {"endpoint_text":"- The primary evaluation criterion is the paired difference in the 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","definition_or_measurement_approach":"Paired differences in parameters of computational models characterizing learning during a stable accumulation task and a dynamic accumulation task, comparing atomoxetine (sNRI) versus placebo."}

Secondary endpoints

• {"endpoint_text":"- Continued EEG recording during the neuropsychological tests at V1 and V2, and its correlation with different latent variables of the learning process, between the atomoxetine and placebo conditions","definition_or_measurement_approach":"Continuous EEG during neuropsychological tests at V1 and V2; analysis correlating EEG signals with latent computational variables comparing atomoxetine vs placebo."}
• {"endpoint_text":"- Paired differences in the pupil diameter recorded using an eye-tracking device, and its correlation with different latent variables of the learning process, between the atomoxetine and placebo conditions","definition_or_measurement_approach":"Pupil diameter recorded using an eye-tracking device; paired differences and correlation with latent variables of learning between atomoxetine and placebo."}
• {"endpoint_text":"- Paired differences in ECG, and its correlation with different latent variables of the learning process, between the atomoxetine and placebo conditions during the neuropsychological tests","definition_or_measurement_approach":"ECG recordings during neuropsychological tests; paired differences and correlation with latent learning variables between conditions."}
• {"endpoint_text":"- Paired difference in salivary cortisol concentration as an indirect marker of noradrenaline function between the atomoxetine and placebo condition","definition_or_measurement_approach":"Salivary cortisol concentration measured and compared (paired differences) between atomoxetine and placebo as an indirect marker of noradrenergic function."}
• {"endpoint_text":"- Psychometric scales at the end of the neuropsychological tests at V1 and V2: • State Trait Anxiety Inventory (STAI) - to measure anxiety levels, • Beck Depression Inventory (BDI) - to measure the level of depression (Beck et al., 1996), • Visual Analog Scales (VAS) for intensity of anxiety, sadness and fatigue","definition_or_measurement_approach":"Administration of STAI, BDI and VAS at end of neuropsychological tests at V1 and V2; scores compared between atomoxetine and placebo conditions."}
• {"endpoint_text":"- Side effects in all groups between study drug administration (D0) and V2 including vital signs worsening and ECG findings","definition_or_measurement_approach":"Recording adverse events, vital signs and ECG findings from administration (D0) to V2 across groups to assess tolerability."}
• {"endpoint_text":"- Genotyping for 3 SNPs in genes assumed to affect noradrenergic function: ADRA2 (rs1800544) and two of the NET (rs28386840, rs2242446)","definition_or_measurement_approach":"Genotyping participants for specified SNPs (ADRA2 rs1800544; NET rs28386840 and rs2242446) to explore genetic correlates."}

France

Latest Decision Or Authorization Date

12-01-2026

Number Of Sites

1

Number Of Participants

176

Primary sponsor

Full Name

Groupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France