ClinicalTrials.gg
Not yet recruitingNCT07771595STEAMUpdated Aug 18, 2026

Study of the Effects of Atomoxetine on Motivation

A Phase 4 interventional study of Atomoxetine and Placebo in Apathy, sponsored by University of Oxford. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-18.

Sponsored by University of Oxford · Phase 4, Interventional, and Other

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Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Apathy

Keywords

  • Atomoxetine
  • Apathy
  • Motivation
  • Reward Processing
03

In context

Lead sponsor

University of Oxford is the lead sponsor of 813 studies on the registry; 120 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age: 18-45
  • Good physical health
  • Willing and able to give to participate in the study
  • Sufficient knowledge of English language to understand and complete the study tasks

Exclusion criteria

Exclusion Criteria:

  • Current 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.
  • Severely underweight ( \<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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Phase 4
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Sequence A: Atomoxetine → Placebo

    Participants receive a single dose of atomoxetine (40 mg) at visit 1 and placebo at visit 2.

    Drug: Atomoxetine · Other: Placebo

  • Experimental
    Sequence B: Placebo → Atomoxetine

    Participants receive a single dose of placebo at visit 1 and atomoxetine (40 mg) at visit 2.

    Drug: Atomoxetine · Other: Placebo

Interventions

  • Acute (single dose) of Atomoxetine (40mg). Oral administration. Atomoxetine is FDA approved for the treatment of ADHD in adults and children.

  • OtherPlacebo

    Sucrose pillules will be encapsulated in an opaque capsule (identical to the experimental drug).

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: During the post-dose task battery, approximately 2-3 hours after single dose of atomoxetine or placebo.

  2. 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.

    Time frame: During the post-dose task battery, approximately 2-3 hours after single dose of atomoxetine or placebo

Secondary outcomes

  1. 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.

    Time frame: During the post-dose task battery, approximately 2-3 hours after single dose of atomoxetine or placebo.

  2. 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.

    Time frame: During the post-dose task battery, approximately 2-3 hours after single dose of atomoxetine or placebo.

  3. 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.

    Time frame: During the post-dose task battery, approximately 2-3 hours after single dose of atomoxetine or placebo.

  4. Affective Go/No-Go Task Behavioural Performance

    Change in behavioural performance, (response time; accuracy) on the Affective Go/No-Go Task.

    Time frame: During the post-dose task battery, approximately 2-3 hours after single dose of atomoxetine or placebo.

  5. 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.

    Time frame: During the post-dose task battery, approximately 2-3 hours after single dose of atomoxetine or placebo.

  6. 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.

    Time frame: During the post-dose task battery, approximately 2-3 hours after single dose of atomoxetine or placebo.

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Informed consent form, Analytic code

Time frame: A few months after all data has been completed (ETA October 2027), unblinding has occurred (ETA November 2027), and all data analyses has been completed (ETA Jan 2029).

Access criteria: The data will be made publicly available. Access requests will not be required.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Aug 2026; primary completion for Oct 2027, 14 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 6, 2026
First posted
Aug 18, 2026
StartEst.
Aug 2026
Primary completionEst.
Oct 2027
CompletionEst.
Oct 2027
Last update
Aug 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07771595
Responsible party
Sponsor
First posted
Aug 18, 2026
Start date
Aug 2026 (estimated)
Primary completion
Oct 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
Aug 18, 2026

Study contacts

Marta M Radzikowska, MSc
Contact
marta.radzikowska@psych.ox.ac.uk
+447933989912
Eva Periche-Tomas, PhD
Contact
eva.perichetomas@psych.ox.ac.uk
+441865 613128
Catherine J Harmer, DPhil
principal investigator · University of Oxford

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Atomoxetine

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