REward Processing And Citalopram Study

NCT06017037 | Unknown Phase 1

• 1 other identifier: REPAC01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this experimental medicine study is to examine the effect of increasing serotonin on reward processing in healthy volunteers. The main questions it aims to answer are:

1. 1.Does a subacute increase in serotonin influence the activation regions during reward learning
2. 2.Does a subacute increase in serotonin influence behavioural markers of reward valuation (effort task), responsiveness (taste task) and learning (learning task)

Conditions

Anhedonia

Outcome Measures

Primary Outcomes (2)

• Reward & aversive learning: behavioural correlates

  Optimal choice learning rate of conditioned stimuli to win and loss outcomes. During an instrumental reinforcement learning task participant will complete trials with a pair of symbols (the valence will either be loss or win, which is implicit). One symbol will be high chance of that outcome (either win or loss depending on the valence of the pair) and the other low chance of the outcome. In the win pair the optimal choice is the high chance symbol (i.e. to win), in the loss pair the optimal choice is the low chance option (i.e. avoid loss). In each allocation group the proportion of participants making an optimal choice will be calculated on a trial-by-trial basis. This provide the learning rate outcome.

  Day 7-9 of treatment

• Reward & aversive learning: neural correlates

  Activity of a network of brain regions associated with reward learning (during anticipation and outcome), in response to a positive \& negative outcomes in reward learning task. This will be the difference in BOLD activation in certain brain regions (pertinent to reward processing) between allocation groups during the anticipation stage and the outcome stage of the instrumental learning task.

  Day 7-9 of treatment

Secondary Outcomes (5)

• Resting state

  Day 7-9 of treatment

• Subjective rating of primary reward

  Day 0 and day 7-9 of treatment

• Reward & aversive learning: behavioural volatile reward learning task: total money won

  day 7-9 of treatment

• Motivational reward task

  day 7-9 of treatment

• Reward & aversive learning: behavioural volatile reward learning task: learning rate

  day 7-9 of treatment

Study Arms (2)

Citalopram

EXPERIMENTAL

Citalopram 20mg p.o. once daily for 7-9 days

Drug: Citalopram 20mg

Placebo

PLACEBO COMPARATOR

Lactose p.o. once daily for 7-9 days

Drug: Placebo

Interventions

Citalopram 20mg DRUG

Citalopram 20mg tablets, encapsulated to aid blinding. To take per oral once daily for 7-9 days

Citalopram

Placebo DRUG

Lactose monohydrate tablets encapsulated to aid blinding. To take per oral once daily for 7-9 days

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is willing and able to give informed consent for participation in the research
• Aged between 18 to 65 years
• Sufficient knowledge of English language to understand and complete study tasks

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 citalopram or affect the scientific integrity of the study
• Previous suicide attempt or previous prolonged period (e.g. \> 5 days) of thoughts to end life
• Known contraindication to citalopram including: past allergic reaction to citalopram or any other medicines, diagnosis of a cardiovascular condition, glaucoma, type 1 or type 2 diabetes, diagnosis of epilepsy, previous diagnosis of angle-closure glaucoma, or current use of any other medication whose use interacts with citalopram (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, neurological 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 250ml cups/cans of coffee/energy drinks per day)
• Lactose intolerance (due to the study involving administration of a lactose placebo tablet)
• Known allergy to citric acid, sodium chloride, sucrose or quinine
• 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 substance use within previous three months

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Neurosciences building, Department of Psychiatry, Warneford hospital

Oxford, Oxfordshire, OX3 7JX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Anhedonia

Interventions

Citalopram

Condition Hierarchy (Ancestors)

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 Harmer, PhD

  University of Oxford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Smith, MBBS

CONTACT

07865 618318; alexander.smith@psych.ox.ac.uk

Susannah Murphy, PhD

CONTACT

susannah.murphy@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: May 15, 2023
• First Posted: August 30, 2023
• Study Start: May 19, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: August 30, 2023

Record last verified: 2023-05

Locations

GB (1)