REward Processing And Citalopram Study

Last updated: August 23, 2023
Sponsor: University of Oxford
Overall Status: Active - Recruiting

Phase

1/2

Condition

N/A

Treatment

Placebo

Citalopram 20mg

Clinical Study ID

NCT06017037
REPAC01
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Current or past probable diagnosis of psychiatric illness, according to DSM-5criteria, requiring intervention by a healthcare professional, including but notlimited to psychosis, bipolar disorder, major depression, OCD, PTSD, substance abusedisorder or any eating disorder
  • Current or past diagnosis of any significant personality disorder (e.g. borderlinepersonality disorder) according to self-report
  • Diagnosis of attention deficit hyperactive disorder or autistic spectrum disorder thatimpairs daily functioning, requires pharmacotherapy or in the opinion of the studymedic would affect the scientific integrity of the study
  • Current use of medication that might interact with the effects of citalopram or affectthe scientific integrity of the study
  • Previous suicide attempt or previous prolonged period (e.g. > 5 days) of thoughts toend life
  • Known contraindication to citalopram including: past allergic reaction to citalopramor any other medicines, diagnosis of a cardiovascular condition, glaucoma, type 1 ortype 2 diabetes, diagnosis of epilepsy, previous diagnosis of angle-closure glaucoma,or current use of any other medication whose use interacts with citalopram (accordingto BNF guidance) e.g. associated with prolonged QT-interval
  • Any other current or past medical conditions which in the opinion of the study medicmay interfere with the safety of the participant or the scientific integrity of thestudy including epilepsy/seizures, brain injury, hepatic or renal disease, diabetes,severe gastro-intestinal problems, Central Nervous System (CNS) tumours, neurologicalconditions
  • First-degree relative with a diagnosis of schizophrenia-spectrum or other psychoticdisorder, or bipolar disorder
  • Severely underweight (BMI<17) or very obese (BMI>40) in a manner that renders themunsuitable 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 placebotablet)
  • Known allergy to citric acid, sodium chloride, sucrose or quinine
  • Pregnancy (as determined by urine pregnancy test taken during the Part 2 screeningvisit), breast feeding or plans to become pregnant
  • past history of dependence on illicit substances or regular illicit substance usewithin 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 involvinguse of citalopram in the last year
  • physical (including visual and auditory) or language impairment that would makecomplying 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 unsuitablefor any other reason, in the opinion of the Investigator
  • Not suitable for MRI neuroimaging e.g. claustrophobia, difficulty remaining still forduration of scan
  • Any MRI contraindications outlined in FMRIB 3 Tesla scanning safety form

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1/2
Study Start date:
May 19, 2023
Estimated Completion Date:
May 01, 2024

Connect with a study center

  • Neurosciences building, Department of Psychiatry, Warneford hospital

    Oxford, Oxfordshire OX3 7JX
    United Kingdom

    Active - Recruiting

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