Last updated: August 23, 2023
Sponsor: University of Oxford
Overall Status: Active - Recruiting
Phase
1/2
Condition
N/ATreatment
Placebo
Citalopram 20mg
Clinical Study ID
NCT06017037
REPAC01
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
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 KingdomActive - Recruiting
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