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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)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-520959-90-00
Acronym
D24-P017
Enrollment
176
Registered
2025-06-26
Start date
2025-11-18
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy subjects with no neurological or psychiatric disorders

Brief summary

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

Detailed description

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, 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, 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, Paired difference in salivary cortisol concentration as an indirect marker of noradrenaline function between the atomoxetine and placebo condition, 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, Side effects in all groups between study drug administration (D0) and V2 including vital signs worsening and ECG findings, Genotyping for 3 SNPs in genes assumed to affect noradrenergic function: ADRA2 (rs1800544) and two of the NET (rs28386840, rs2242446)

Interventions

DRUGAtomoxetin STADA 40 mg Hartkapseln

Sponsors

Groupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
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, 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, 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, Paired difference in salivary cortisol concentration as an indirect marker of noradrenaline function between the atomoxetine and placebo condition, 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

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026