Effort and Antidepressant Study Test

NCT06696482 | Not Yet Recruiting Phase 1

• 1 other identifier: EAST_Study
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Effort Based Decision Making; Prosocial Behavior; Apathy

Keywords

fMRI

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  Day 7 of treatment

Secondary Outcomes (2)

• Emotional processing: Faces task

  Day 7 of treatment

• Prosocial behaviour: Social learning task

  Day 7 of treatment

Study Arms (2)

Escitalopram

EXPERIMENTAL

Escitalopram tablets 10 mg once daily for 7 days

Drug: Escitalopram 10mg

Placebo

PLACEBO COMPARATOR

Lactose tablets 10 mg once daily for 7 days

Drug: Placebo 10 mg

Interventions

Escitalopram 10mg DRUG

Escitalopram 10 mg, encapsulated in an opaque capsule to facilitate blinding of participant and researcher

Escitalopram

Placebo 10 mg DRUG

Placebo 10 mg, encapsulated in an opaque capsule to facilitate blinding of participant and researcher

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Oxford: lead
• Wellcome Trust: collaborator

MeSH Terms

Conditions

Altruism; Lethargy

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Catherine J Harmer, PhD

  University of Oxford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Periche-Tomas, PhD

CONTACT

+44 (0) 1865613128; eva.perichetomas@psych.ox.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 20, 2024
• Study Start: January 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-11