Health TrialsbyHealthPanel

Study of the Effects of Atomoxetine on Motivation

ConditionApathy
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-45
SponsorUniversity of Oxford

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Atomoxetine

    Drug

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

  • Placebo

    Other intervention

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Sequence A: Atomoxetine → PlaceboExperimental treatment 2 interventions
Group B: Sequence B: Placebo → AtomoxetineExperimental treatment 2 interventions

Trial outcomes

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Oxford

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: