Effort Based Decision MakingPhase 1/2EASTNCT06696482
Effort and Antidepressant Study Test
A Phase 1/2 study testing Escitalopram 10mg in people with Effort Based Decision Making and Prosocial Behavior, run by University of Oxford.
Trial summary
The aim of this study is to investigate the behavioural effects and neural correlates of increasing serotonin levels in healthy volunteers, through a 7-day course of the SSRI escitalopram, on an effort-based decision-making task measuring self-benefiting and prosocial behaviours. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Effort Based Decision Making, Prosocial Behavior, Apathy
- What is being tested?
- Escitalopram 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Sep 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the research
- Aged 18 to 40 years
- Sufficient knowledge of English language to understand and complete study tasks
- Right-handed
Who cannot join
- Current or past probable diagnosis of psychiatric illness, according to DSM-5 criteria requiring intervention by a healthcare professional, including but not limited to psychosis, bipolar disorder, major depression, OCD, PTSD, substance abuse disorder or any eating disorder
- Current or past diagnosis of any significant personality disorder (e.g., borderline personality disorder) according to self-report
- Diagnosis of attention deficit hyperactive disorder or autistic spectrum disorder that impairs daily functioning, requires pharmacotherapy or in the opinion of the study medic would affect the scientific integrity of the study
- Current use of medication that might interact with the effects of escitalopram or affect the scientific integrity of the study
- Previous suicide attempt or previous prolonged period (eg., > 5 days) of thought to end life
- Known contraindication to escitalopram including: past allergic reaction to escitalopram or any other medicines, diagnosis of angle-closure glaucoma, or current use of any other medication whose use interacts with escitalopram (according to BNF guidance) e.g. associated with prolonged QT-interval
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- Any other current or past medical conditions which in the opinion of the study medic may interfere with the safety of the participant or the scientific integrity of the study including epilepsy/seizures, brain injury, hepatic or renal disease, diabetes, severe gastro-intestinal problems, Central Nervous System (CNS) tumours, neurobiological conditions
- First-degree relative with a diagnosis of schizophrenia-spectrum or other psychotic disorder, or bipolar disorder
- Severely underweight (BMI<17) or very obese (BMI>40) in a manner that renders them unsuitable for the study in the opinion of the study medic
- Heavy use of cigarettes (smoke>20 cigarettes per day)
- Heavy use of caffeine (drink>4 x 250 ml cups/cans of coffee/energy drinks per day)
- Lactose intolerance (due to the study involving administration of a lactose placebo tablet)
- Pregnancy (as determined by urine pregnancy test taken during the Part 2 screening visit), breast feeding or plans to become pregnant
- Past history of dependence on illicit substances or regular illicit substances use within the previous three months
- Evidence of current or past harmful use of alcohol
- Previous participation in a study involving the tasks used in this study or involving use of escitalopram in the last year in the Department of Psychiatry (University of Oxford)
- Physical (including visual and auditory) or language impairment that would make complying with the study protocol challenging.
- Participant is unlikely to comply with the clinical study protocol or is unsuitable for any other reason, in the opinion of the investigator
- Not suitable for MRI neuroimaging, e.g., difficulty remaining still for duration of scan
- Any MRI contraindications outlined in FMRIB 3 Tesla scanning safety form
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The aim of this study is to investigate the behavioural effects and neural correlates of increasing serotonin levels in healthy volunteers, through a 7-day course of the SSRI escitalopram, on an effort-based decision-making task measuring self-benefiting and prosocial behaviours.
Read the detailed description
This study investigates the mechanisms behind motivation and apathy, focusing on how effort is dedicated to both self-benefiting and prosocial actions. Diminished motivation, often manifesting as apathy, is associated with poor health outcomes and is common in neurological disorders like Parkinson's, Alzheimer's, and small vessel cerebrovascular disease (SVD). While brain regions like the dorsal anterior cingulate cortex (dACC), dorsomedial prefrontal cortex (dmPFC), and anterior insula (AI) are known to regulate motivation in reward-based decision-making for personal gain, prosocial motivation remains underexplored. Prosocial behaviour involves actions that benefit others and contribute to physical and psychological well-being. Recent studies suggest unique neural activity in the anterior cingulate gyrus (ACCg) during prosocial actions, differing from self-benefiting behaviour.
To the best of our knowledge, there is no prior evidence on how SSRIs might influence prosocial motivation or its neural correlates. This study will address this gap by examining SSRI effects on effort-based prosocial decision-making, potentially identifying novel insights into the neural mechanisms underlying motivation for prosocial behaviour.
- Conditions
- Effort Based Decision Making, Prosocial Behavior, Apathy
- Being tested
- Escitalopram 10mg, Placebo 10 mg
- Keywords
- fMRI
- Medical subject headings
- Altruism, Lethargy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Escitalopram 10mgDrug
Escitalopram 10 mg, encapsulated in an opaque capsule to facilitate blinding of participant and researcher
Placebo 10 mgDrug
Placebo 10 mg, encapsulated in an opaque capsule to facilitate blinding of participant and researcher
| Study group | Role | What they receive |
|---|---|---|
| Escitalopram | Experimental | Escitalopram tablets 10 mg once daily for 7 days Receives: Drug: Escitalopram 10mg |
| Placebo | Placebo comparator | Lactose tablets 10 mg once daily for 7 days Receives: Drug: Placebo 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effort-based decision-making task for self-benefiting and prosocial behaviours: behavioural correlates
In the fMRI scanner task, participants are prompted to choose between two offers on each trial. One option allows them to earn a low reward for minimal effort (rest), while the other presents a variable higher-reward, higher-effort (work) of the same duration. The low-reward, low-effort offer earns 1 point without exertion. Higher-reward, higher-effort offers range from 2 to 10 points (in 2-point-increments) and effort varies from 30% to 70% (in 10% increments) of their MVC.
Each trial differs in whether the outcome is delivered to the participant themselves (self) or someone else (prosocial). Effort levels for each offer are visually represented using coloured portions of a pie chart and rewards (points) are displayed in colour below.
Measured: Day 7 of treatment
Effort-based decision-making for self-benefiting and prosocial behaviours: Neural correlates
Activity of brain regions associated with self-benefiting and prosocial behaviours
Measured: Day 7 of treatment
Secondary outcomes (2)
Emotional processing: Faces task
During the emotional processing face task participants will be presented with pictures of emotional faces and asked to label the emotions into different categories.
Measured: Day 7 of treatment
Prosocial behaviour: Social learning task
This game involves making fictitious investment decisions with other "previous participants in our lab" (programmed responses) and trying to maximize the number of points earned in the game.
Measured: Day 7 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study startJan 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effort Based Decision MakingStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust
- Responsible party
- Sponsor
- Investigators
- Catherine J Harmer, PhD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696482
- Sponsor's protocol ID
- EAST_Study
- Acronym
- EAST
- Status last verified
- Nov 2024
- First submitted
- 15 Nov 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Research data will be anonymised and then processed for analysis. Anonymised data will be made available post-publication on Open Science Framework (OSF). we plan to share normalised MRI data (such that unique brain structure is not shared) into an online scientific data sharing repository such as 'Zenodo'
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effort and Antidepressant Study Test
- ClinicalTrials.gov ID
- NCT06696482
- Acronym / sponsor ID
- EAST / EAST_Study
- Conditions
- Effort Based Decision Making, Prosocial Behavior, Apathy
- Keywords
- fMRI
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Wellcome Trust
- Study start
- Jan 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 20 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the behavioural effects and neural correlates of increasing serotonin levels in healthy volunteers, through a 7-day course of the SSRI escitalopram, on an effort-based decision-making task measuring self-benefiting and prosocial behaviours.
Detailed description
This study investigates the mechanisms behind motivation and apathy, focusing on how effort is dedicated to both self-benefiting and prosocial actions. Diminished motivation, often manifesting as apathy, is associated with poor health outcomes and is common in neurological disorders like Parkinson's, Alzheimer's, and small vessel cerebrovascular disease (SVD). While brain regions like the dorsal anterior cingulate cortex (dACC), dorsomedial prefrontal cortex (dmPFC), and anterior insula (AI) are known to regulate motivation in reward-based decision-making for personal gain, prosocial motivation remains underexplored. Prosocial behaviour involves actions that benefit others and contribute to physical and psychological well-being. Recent studies suggest unique neural activity in the anterior cingulate gyrus (ACCg) during prosocial actions, differing from self-benefiting behaviour.
To the best of our knowledge, there is no prior evidence on how SSRIs might influence prosocial motivation or its neural correlates. This study will address this gap by examining SSRI effects on effort-based prosocial decision-making, potentially identifying novel insights into the neural mechanisms underlying motivation for prosocial behaviour.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Escitalopram | Experimental | Drug: Escitalopram 10mgEscitalopram tablets 10 mg once daily for 7 days |
| Placebo | Placebo comparator | Drug: Placebo 10 mgLactose tablets 10 mg once daily for 7 days |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participant is willing and able to give informed consent for participation in the research
- Aged 18 to 40 years
- Sufficient knowledge of English language to understand and complete study tasks
- Right-handed
Key exclusion criteria (20 listed)
- Current or past probable diagnosis of psychiatric illness, according to DSM-5 criteria requiring intervention by a healthcare professional, including but not limited to psychosis, bipolar disorder, major depression, OCD, PTSD, substance abuse disorder or any eating disorder
- Current or past diagnosis of any significant personality disorder (e.g., borderline personality disorder) according to self-report
- Diagnosis of attention deficit hyperactive disorder or autistic spectrum disorder that impairs daily functioning, requires pharmacotherapy or in the opinion of the study medic would affect the scientific integrity of the study
- Current use of medication that might interact with the effects of escitalopram or affect the scientific integrity of the study
- Previous suicide attempt or previous prolonged period (eg., > 5 days) of thought to end life
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Escitalopram 10mgEscitalopram 10 mg, encapsulated in an opaque capsule to facilitate blinding of participant and researcher | Drug | Escitalopram |
| Placebo 10 mgPlacebo 10 mg, encapsulated in an opaque capsule to facilitate blinding of participant and researcher | Drug | Placebo |
Primary outcome
Effort-based decision-making task for self-benefiting and prosocial behaviours: behavioural correlates
Time frame: Day 7 of treatment
In the fMRI scanner task, participants are prompted to choose between two offers on each trial. One option allows them to earn a low reward for minimal effort (rest), while the other presents a variable higher-reward, higher-effort (work) of the same duration. The low-reward, low-effort offer earns 1 point without exertion. Higher-reward, higher-effort offers range from 2 to 10 points (in 2-point-increments) and effort varies from 30% to 70% (in 10% increments) of their MVC. Each trial differs in whether the outcome is delivered to the participant themselves (self) or someone else (prosocial). Effort levels for each offer are visually represented using coloured portions of a pie chart and rewards (points) are displayed in colour below.
Effort-based decision-making for self-benefiting and prosocial behaviours: Neural correlates
Time frame: Day 7 of treatment
Activity of brain regions associated with self-benefiting and prosocial behaviours
2 secondary outcomes
Emotional processing: Faces task
Time frame: Day 7 of treatment
Prosocial behaviour: Social learning task
Time frame: Day 7 of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: Undecided. Research data will be anonymised and then processed for analysis. Anonymised data will be made available post-publication on Open Science Framework (OSF). we plan to share normalised MRI data (such that unique brain structure is not shared) into an online scientific data sharing repository such as 'Zenodo'
Related trials for Effort Based Decision Making
Not yet recruiting
Multimodal Differences in Effort-based Decision-Making in Depression
Depression, Anhedonia
Not yet recruiting
Fluoxetine and Understanding Social Experiences
Depression in Adolescence, Antidepressant Activity in Healthy Volunteers
Recruiting
Effort-based Decision-making and CPAP Adherence
Obstructive Sleep Apnea, Adherence
Recruiting
The Relationships Between Neural Correlates of Effort Perception and Physical Activity Engagement
fMRI Research, Transcranial Magnetic Stimilation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Catherine J Harmer, PhD principal investigator
University of Oxford
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Escitalopram 10mg in people with Effort Based Decision Making and Prosocial Behavior, run by University of Oxford.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eva Periche-Tomas, PhD (+44 (0) 1865613128, eva.perichetomas@psych.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effort-based decision-making task for self-benefiting and prosocial behaviours: behavioural correlates (time frame: Day 7 of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.