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STEAM
NCT07771595Phase 4
Key facts
- Status
- Not yet recruiting
- Start
- Aug 2026
- Primary completion
- Oct 2027
- Countries
- 1
- Sponsor
- University of Oxford
- Drugs
- atomoxetine
- Conditions
- apathy
01
Overview
Phase 4, randomised, double-blind trial of atomoxetine in apathy (2 arms), sponsored by University of Oxford. Primary endpoints: Effort-based choice behaviour during the Apple Gathering Task and Effort-based choice behaviour during the Mental Effort Task. Planned start Aug 2026; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Sequence A: Atomoxetine → Placebo
Participants receive a single dose of atomoxetine (40 mg) at visit 1 and placebo at visit 2.
Sequence B: Placebo → Atomoxetine
Participants receive a single dose of placebo at visit 1 and atomoxetine (40 mg) at visit 2.
03
Who it enrols
Healthy adults aged 18-45 with varying levels of apathy, excluding those with psychiatric disorders, ADHD, cardiovascular/respiratory/liver/kidney issues, or recent use of CNS/heart medications.
04
Endpoints
Primary
Effort-based choice behaviour during the Apple Gathering Task
Effort-based choice behaviour during the Mental Effort Task
Secondary
Prior goal precision on the Goal Priors Assay Task
Reinforcement learning under working memory load task behavioural performance
Reinforcement learning under working memory load task parameter estimate
Affective Go/No-Go Task Behavioural Performance
Reward sensitivity computational parameter estimates from effort-based decision-making tasks
Effort sensitivity computational parameter estimates from effort-based decision-making tasks
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