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Atomoxetine

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.

Table of Contents

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.[1][2][3]

The trials are in Phase 2 and Phase 3, and they use different comparison treatments such as placebo or treatment as usual.[1][2][3]

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.[1]

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.[1]

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.[1]

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.[1]

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.[2]

This Phase 2 trial compares a single dose of Atomoxetine 40 mg with placebo, which is a dummy treatment used for comparison.[2]

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.[2]

The primary evaluation criterion is the paired difference in computational model parameters that describe the learning process between the Atomoxetine and placebo conditions.[2]

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.[3]

The trial studies whether Atomoxetine can reduce freezing of gait, which means sudden stopping or pausing while walking.[3]

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.[3]

The planned enrollment is 60 participants.[3]

Main endpoints and what they mean

Each trial has a different primary outcome, which is the main result the researchers want to measure.[1][2][3]

  • In the depression study, the main endpoint is the change in MADRS score at six weeks, which shows whether symptoms improved or worsened.[1]

  • In the learning study, the main endpoint is the difference in computational model results between Atomoxetine and placebo, which helps researchers study learning behavior.[2]

  • In the Parkinson’s study, the main endpoint is the percentage of time frozen during walking tasks, which shows how often walking stops happen.[3]

Who can participate

The target population depends on the trial and its research question.[1][2][3]

  • People with major depressive disorder who had a first-time treatment failure on first-line treatment may be included in the depression study.[1]

  • Healthy subjects with no neurological or psychiatric disorders may be included in the learning study.[2]

  • People with Parkinson’s disease may be included in the gait study.[3]

Study design and phases

All three studies are interventional, which means the researchers give a study treatment and compare outcomes.[1][2][3]

NCT05973851 and 2024-516756-18-00 are Phase 3 trials, while 2025-520959-90-00 is a Phase 2 trial.[1][2][3]

The studies use different comparators, including treatment as usual, placebo, and a gelatin capsule control.[1][2][3]

Trial ID Phase Condition studied Status Enrollment
NCT05973851 Phase 3 Major depressive disorder Authorised 453
2025-520959-90-00 Phase 2 Healthy subjects with no neurological or psychiatric disorders Authorised 176
2024-516756-18-00 Phase 3 Parkinson’s disease Authorised 60

FAQ

  • What are clinical trials with Atomoxetine trying to find out? They are testing whether Atomoxetine helps with different study goals, such as improving depression symptoms, changing learning patterns, or reducing freezing of gait in Parkinson’s disease. The trials also measure how Atomoxetine compares with placebo or usual care.
  • Who can take part in Atomoxetine trials? The target groups differ by trial. One study includes people with major depressive disorder, one includes healthy adults without neurological or psychiatric disorders, and one includes people with Parkinson’s disease.
  • What phases are the Atomoxetine trials in? The trials listed are in Phase 2 and Phase 3. Phase 2 usually looks at early effects and study measures, while Phase 3 compares treatments in larger groups.
  • What conditions are being studied with Atomoxetine? The trials are studying major depressive disorder, learning dynamics in healthy subjects, and freezing of gait in Parkinson’s disease. Each trial has a different main goal and patient group.
  • What outcomes are being measured in these trials? The studies measure different outcomes depending on the trial. These include depression symptom scores, learning model results, pupil size, EEG responses, and the percentage of time frozen during walking tasks.

Ongoing Clinical Trials on Atomoxetine

  • Effect of atomoxetine on learning dynamics in healthy adults: a study comparing single dose atomoxetine 40 mg with placebo

    Recruiting

    2 1 1
    Investigated drugs:
    France

  • Study of Atomoxetine to Reduce Freezing of Gait in Patients with Parkinson’s Disease During OFF-State

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on the Effect of Ketamine and Esketamine in Patients with Major Depressive Disorder After First-Line Treatment Failure

    Recruiting

    3 1 1 1
    Investigated drugs:
    Austria Germany Greece Italy Spain

Glossary

  • Clinical trial: A research study in people that tests whether a treatment or approach works and is safe enough for further study.
  • Interventional study: A study where researchers give a treatment or placebo and then compare results.
  • Phase 2: An early stage of testing that looks at how a treatment behaves in people and what effects it may have.
  • Phase 3: A later stage of testing in larger groups, usually to compare treatments more fully.
  • Placebo: A look-alike treatment with no active study drug, used to compare results fairly.
  • Major depressive disorder: A medical condition with ongoing low mood and other symptoms that can affect daily life.
  • MADRS: Short for Montgomery Åsberg Depression Rating Scale. It is a score used to measure depression symptom severity.
  • Freezing of gait: A sudden short pause or stop while walking, often seen in Parkinson’s disease.
  • Dopaminergic OFF-state: A time when Parkinson’s disease symptoms are studied without the usual dopamine-based treatment effect.
  • EEG: Short for electroencephalography. It is a test that records brain electrical activity.
  • Pupil diameter: The size of the black center of the eye, which can be measured as part of a study.
  • Computational model: A math-based way to study how people learn or make decisions during a task.

References