Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2023-05-19
2024-05-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Citalopram
Citalopram 20mg p.o. once daily for 7-9 days
Citalopram 20mg
Citalopram 20mg tablets, encapsulated to aid blinding. To take per oral once daily for 7-9 days
Placebo
Lactose p.o. once daily for 7-9 days
Placebo
Lactose monohydrate tablets encapsulated to aid blinding. To take per oral once daily for 7-9 days
Interventions
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Citalopram 20mg
Citalopram 20mg tablets, encapsulated to aid blinding. To take per oral once daily for 7-9 days
Placebo
Lactose monohydrate tablets encapsulated to aid blinding. To take per oral once daily for 7-9 days
Eligibility Criteria
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Inclusion Criteria
* Aged between 18 to 65 years
* Sufficient knowledge of English language to understand and complete study tasks
Exclusion Criteria
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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University of Oxford
OTHER
Responsible Party
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Principal Investigators
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Catherine Harmer, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Oxford
Locations
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Neurosciences building, Department of Psychiatry, Warneford hospital
Oxford, Oxfordshire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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REPAC01
Identifier Type: -
Identifier Source: org_study_id
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