ApathyPhase 4STEAMNCT07771595
Study of the Effects of Atomoxetine on Motivation
A Phase 4 study testing Atomoxetine in people with Apathy, run by University of Oxford at 1 site in United Kingdom.
Trial summary
This study investigates how increasing noradrenaline levels with atomoxetine affects motivation and information processing relevant to apathy. Apathy, characterised by low motivation and reduced goal-directed behaviour, is common across neuropsychiatric disorders and is associated with poorer outcomes. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Apathy
- What is being tested?
- Atomoxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2026to Oct 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-45
- Good physical health
- Willing and able to give informed consent to participate in the study
- Sufficient knowledge of English language to understand and complete the study tasks
Who cannot join
- Current DSM-5 axis-I diagnosis (based on SCID results at screening) or history of a severe psychological disorder such as psychotic disorder, bipolar disorder, alcohol or substance abuse, or post-traumatic stress disorder
- Previous or current extended period of persistent thoughts about ending one's life (longer than 5 days) or previous suicide attempt
- Clinical diagnosis of attention deficit hyperactivity disorder (ADHD) or on the waiting list for assessment
- Any intake of CNS-medication in the last 6 weeks (including as part of another study)
- Any current intake of blood pressure or other heart medication, including beta blockers
- Any current or previous medical condition or medication intake (last month) of any medication that, in the opinion of the study medic, may interfere with the safety of the participant or the scientific integrity of the study.
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- Severely underweight (BMI <17) or very obese (BMI >40), OR otherwise deemed unsuitable for the study due to weight-related concerns at the discretion of the study medic
- History of cardiovascular, cerebrovascular disease
- Breathing or lung-related illnesses, significant liver or kidney problems, or severe gastrointestinal conditions.
- High blood pressure (defined as repeated measurements of blood pressure where either the systolic or the diastolic blood pressure, or both, are at or above 140/90 mmHg (https://doi.org/10.1093/eurheartj/ehy339)
- History of recurrent rashes or history of allergic reactions to relevant substances (atomoxetine, placebo treatment)
- Significant physical (including visual and auditory) or language impairment that would make complying with the study protocol challenging.
- History of palpitations with sudden onset and offset,
- History of fainting on exertion or in response to fright or loud noise
- Family history of sudden death in a first-degree relative under 40 years of age
- Women: pregnancy (as determined by a urine test), breast-feeding
- Significant consumption of caffeine (more than about 6 cups of strong coffee per day), nicotine (more than 5 cigarettes per day, or equivalent amount), alcohol (more than two pints of beer a day or equivalent)
- Participation in a study that involves the use of medication in the past 3 months
- Participation in another study using similar tasks in the past 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Department of Psychiatry, University of Oxford
Oxford, OX3 7JX
Eva Periche-Tomas, PhD, +441865 613128, eva.perichetomas@psych.ox.ac.uk
Marta M Radzikowska, MSc, +447933989912, marta.radzikowska@psych.ox.ac.uk
About this study
Official title: The Effects of Single Dose Atomoxetine on Motivation and Information Processing
This study investigates how increasing noradrenaline levels with atomoxetine affects motivation and information processing relevant to apathy. Apathy, characterised by low motivation and reduced goal-directed behaviour, is common across neuropsychiatric disorders and is associated with poorer outcomes. Atomoxetine, a noradrenaline reuptake inhibitor, has been shown to influence effort, reward learning, and decision-making; however, its effects on cognitive processes relevant to apathy remain unclear.
This study will investigate how pharmacologically increasing noradrenaline levels with atomoxetine affects different components of motivation altered in apathy, including reward processing, effort-based decision-making, goal-directed behaviour, and learning.
In a within-subject, double-blind, placebo-controlled, randomised study, forty healthy participants with varying levels of apathy will complete a computerised task battery after receiving a single dose of atomoxetine (40 mg) and placebo. Validated tasks assessing motivation, reward learning, decision-making, goal-directed behaviour, and information processing will be used to examine whether and how atomoxetine influences motivation-related cognitive processes.
- Conditions
- Apathy
- Being tested
- Atomoxetine, Placebo
- Keywords
- Atomoxetine, Apathy, Motivation, Reward Processing
- Medical subject headings
- Lethargy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtomoxetineDrug
Acute (single dose) of Atomoxetine (40mg). Oral administration. Atomoxetine is FDA approved for the treatment of ADHD in adults and children.
PlaceboOther
Sucrose pillules will be encapsulated in an opaque capsule (identical to the experimental drug).
| Study group | Role | What they receive |
|---|---|---|
| Sequence A: Atomoxetine → Placebo | Experimental | Participants receive a single dose of atomoxetine (40 mg) at visit 1 and placebo at visit 2. Receives: Drug: Atomoxetine; Other: Placebo |
| Sequence B: Placebo → Atomoxetine | Experimental | Participants receive a single dose of placebo at visit 1 and atomoxetine (40 mg) at visit 2. Receives: Drug: Atomoxetine; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effort-based choice behaviour during the Apple Gathering Task
Change in the acceptance rate of offers requiring varying levels of physical effort for reward, measured during the Apple Gathering Task. Higher acceptance rates indicate greater willingness to exert effort for reward.
Measured: During the post-dose task battery, approximately 2-3 hours after single dose of atomoxetine or placebo.
Effort-based choice behaviour during the Mental Effort Task
Change in the acceptance rate of offers requiring varying levels of cognitive effort for reward, measured during the Mental Effort Task. Higher acceptance rates indicate greater willingness to exert cognitive effort for reward.
Measured: During the post-dose task battery, approximately 2-3 hours after single dose of atomoxetine or placebo
Secondary outcomes (6)
Prior goal precision on the Goal Priors Assay Task
Estimated prior goal precision derived from the relationship between estimation error (difference between estimated and actual ball landing position) and performance error (difference between actual ball landing position and target position). Higher values indicate greater weighting of prior beliefs relative to sensory evidence.
Measured: During the post-dose task battery, approximately 2-3 hours after single dose of atomoxetine or placebo.
Reinforcement learning under working memory load task behavioural performance
Change in behavioural performance, measured as the proportion of optimal choices across low and high working memory load conditions.
Measured: During the post-dose task battery, approximately 2-3 hours after single dose of atomoxetine or placebo.
Reinforcement learning under working memory load task parameter estimate
Change in participant-specific learning rate parameter estimate derived from computational modelling of learning and working memory task performance across low and high working memory load conditions.
Measured: During the post-dose task battery, approximately 2-3 hours after single dose of atomoxetine or placebo.
Affective Go/No-Go Task Behavioural Performance
Change in behavioural performance, (response time; accuracy) on the Affective Go/No-Go Task.
Measured: During the post-dose task battery, approximately 2-3 hours after single dose of atomoxetine or placebo.
Reward sensitivity computational parameter estimates from effort-based decision-making tasks.
Change in participant-specific parameter estimates of reward sensitivity derived from computational modelling of performance on the Apple Gathering Task and Mental Effort Task.
Measured: During the post-dose task battery, approximately 2-3 hours after single dose of atomoxetine or placebo.
Effort sensitivity computational parameter estimates from effort-based decision-making tasks.
Change in participant-specific effort sensitivity parameter derived from computational modelling of performance on the Apple Gathering Task and Mental Effort Task.
Measured: During the post-dose task battery, approximately 2-3 hours after single dose of atomoxetine or placebo.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ApathyStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- In a within-subject, double-blind, placebo-controlled, randomised study, forty healthy participants with varying levels of apathy will complete a computerised task battery after receiving a single dose of atomoxetine (40 mg) and placebo. Participants will complete two visits, 21 to 30 days apart.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine J Harmer, DPhil, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771595
- Sponsor's protocol ID
- MS IDREC 2605385
- Acronym
- STEAM
- Status last verified
- Apr 2026
- First submitted
- 6 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data which has been fully de-identified may be shared with other academic and commercial organisations in the future, including those outside of the UK and the EU. Participants will be informed of this and specific consent to this is obtained within the Informed Consent Form.