In short
Clinical trials investigating Atomoxetine are studying different patient groups, including people with major depressive disorder, healthy volunteers, and people with Parkinson’s disease. These trials aim to evaluate outcomes such as symptom change, learning measures, and freezing of gait, as well as compare Atomoxetine with placebo or usual treatment.
Key points
- Clinical trials of Atomoxetine are being done in three very different groups: people with major depressive disorder, healthy volunteers, and people with Parkinson’s disease. The studies are in Phase 2 and Phase 3, so they are looking at both early research questions and larger comparisons. One trial measures depression symptom change with the MADRS score, another studies learning tasks, pupil size, and EEG responses, and a third looks at freezing of gait. The trials compare Atomoxetine with placebo or usual treatment, depending on the study. Together, they show that Atomoxetine is being studied for different research goals, not just one condition.
Trial overview
Three authorised interventional trials are studying Atomoxetine in very different groups: people with major depressive disorder, healthy subjects without neurological or psychiatric disorders, and people with Parkinson’s disease.
The trials are in Phase 2 and Phase 3, and they use different comparison treatments such as placebo or treatment as usual.
Major depressive disorder study
NCT05973851 is a randomised controlled trial in people with major depressive disorder who had a first-time treatment failure on their first-line treatment.
This Phase 3 study compares a six-week intensified pharmacological treatment with treatment as usual, and Atomoxetine is one of the drugs listed in the intensified treatment group.
The main outcome is the change in depression symptom severity after six weeks, measured with the MADRS, which is a scale used to score how severe depression symptoms are.
The study includes subgroup analysis, meaning the researchers will also look separately at participants who had a first-time treatment failure on first-line treatment.
Learning dynamics study in healthy subjects
Trial 2025-520959-90-00 studies the role of the noradrenergic system in learning dynamics in healthy subjects with no neurological or psychiatric disorders.
This Phase 2 trial compares a single dose of Atomoxetine 40 mg with placebo, which is a dummy treatment used for comparison.
The study looks at how people perform in a stable accumulation task and a dynamic accumulation task, and it also measures pupil diameter and EEG responses.
The primary evaluation criterion is the paired difference in computational model parameters that describe the learning process between the Atomoxetine and placebo conditions.
Parkinson’s disease study
Trial 2024-516756-18-00 is a Phase 3, multi-center and multi-modal study in people with Parkinson's disease.
The trial studies whether Atomoxetine can reduce freezing of gait, which means sudden stopping or pausing while walking.
The study compares Atomoxetine with placebo and measures the percentage of time frozen during gait tasks in the dopaminergic OFF-state, meaning a time when Parkinson’s symptoms are assessed without the usual dopamine-based treatment effect.
The planned enrollment is 60 participants.
Main endpoints and what they mean
Each trial has a different primary outcome, which is the main result the researchers want to measure.
- In the depression study, the main endpoint is the change in MADRS score at six weeks, which shows whether symptoms improved or worsened.
- In the learning study, the main endpoint is the difference in computational model results between Atomoxetine and placebo, which helps researchers study learning behavior.
- In the Parkinson’s study, the main endpoint is the percentage of time frozen during walking tasks, which shows how often walking stops happen.
Who can participate
The target population depends on the trial and its research question.
- People with major depressive disorder who had a first-time treatment failure on first-line treatment may be included in the depression study.
- Healthy subjects with no neurological or psychiatric disorders may be included in the learning study.
- People with Parkinson’s disease may be included in the gait study.
Study design and phases
All three studies are interventional, which means the researchers give a study treatment and compare outcomes.
NCT05973851 and 2024-516756-18-00 are Phase 3 trials, while 2025-520959-90-00 is a Phase 2 trial.
The studies use different comparators, including treatment as usual, placebo, and a gelatin capsule control.