ClinicalTrials.gg
Status unknownNCT06017037REPACUpdated Aug 30, 2023

REward Processing And Citalopram Study

A Phase 1/2 interventional study of Citalopram 20mg and Placebo in Anhedonia, sponsored by University of Oxford. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-30.

Sponsored by University of Oxford · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

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

Participants will be:

given a 7-day course of the selective serotonin reuptake inhibitor, citalopram. undergo behavioural testing complete a reward learning task whilst undergoing fMRI

Researchers will compare results against a placebo group.

02

Conditions studied

  • Anhedonia

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03

In context

Anhedonia

122 studies on the registry are indexed under Anhedonia; 45 are open to participants now.

This study's planned enrollment of 40 is below the median of 70 across 102 interventional studies indexed under Anhedonia.

Browse Anhedonia studies →

Lead sponsor

University of Oxford is the lead sponsor of 812 studies on the registry; 119 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 65 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

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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 citalopram in the last year
  • physical (including visual and auditory) or language impairment that would make complying with the study protocol challenging
  • ongoing deficit in sense of smell or taste e.g. following Covid-19 infection
  • 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. claustrophobia, difficulty remaining still for duration of scan
  • Any MRI contraindications outlined in FMRIB 3 Tesla scanning safety form
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Citalopram

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

    Drug: Citalopram 20mg

  • Placebo comparator
    Placebo

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

    Drug: Placebo

Interventions

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

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 7-9 of treatment

  2. 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.

    Time frame: Day 7-9 of treatment

Secondary outcomes

  1. Resting state

    Resting state fMRI activation

    Time frame: Day 7-9 of treatment

  2. Subjective rating of primary reward

    Subjective rating of four tastes (sweet, salt, sour \& bitter) in terms of intensity, anticipation of pleasurableness and actual pleasurableness.

    Time frame: Day 0 and day 7-9 of treatment

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

    Amount of money won/lost \& total amount of money received.

    Time frame: day 7-9 of treatment

  4. Motivational reward task

    Participants are asked to accept or decline hypothetical offers made of various combinations of reward and physical effort (grip strength). For a limited number of offers participants are asked to actually expend effort for offers too. The investigators will examine 1. Proportion of offer acceptance for various levels of reward and effort 2. proportion of accepted offers successfully obtained

    Time frame: day 7-9 of treatment

  5. Reward & aversive learning: behavioural volatile reward learning task: learning rate

    Learning rate of optimal choices changes during the task. Proportion of participants in each allocation arm making an optimal choice on a trial-by-trial basis will provide the learning rate for each group. Provides sensitive measure of reward and aversive learning rates.

    Time frame: day 7-9 of treatment

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — Research data will be anonymised and then processed for analysis. Anonymised data will be made available post-publication on Open Science Framework (OSF). defaced neural images will be shared via governed access through Zenodo with data sharing agreements in place

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2023 (actual). Primary completion is estimated for May 2024, 11 months after the start.

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

Registered
May 15, 2023
First posted
Aug 30, 2023
StartActual
May 19, 2023
Primary completionEst.
May 1, 2024
CompletionEst.
May 1, 2024
Last update
Aug 30, 2023
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 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06017037
Responsible party
Sponsor
First posted
Aug 30, 2023
Start date
May 19, 2023
Primary completion
May 1, 2024 (estimated)
Completion
May 1, 2024 (estimated)
Last update
Aug 30, 2023

Study contacts

Alexander Smith, MBBS
Contact
alexander.smith@psych.ox.ac.uk
07865 618318
Susannah Murphy, PhD
Contact
susannah.murphy@psych.ox.ac.uk
Catherine Harmer, PhD
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 ↗

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Studies of the drug tested here: Citalopram

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