REward Processing And Citalopram Study

NCT ID: NCT06017037

Last Updated: 2023-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-19

Study Completion Date

2024-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anhedonia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Citalopram

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

Group Type EXPERIMENTAL

Citalopram 20mg

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Citalopram 20mg

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Oxford

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Catherine Harmer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Neurosciences building, Department of Psychiatry, Warneford hospital

Oxford, Oxfordshire, United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Alexander Smith, MBBS

Role: CONTACT

07865 618318

Susannah Murphy, PhD

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Alexander Smith

Role: primary

01865618339

Catherine harmer

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REPAC01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Citalopram and Stress Reactivity
NCT04161209 UNKNOWN NA
Citalopram to Enhance Cognition in HD
NCT00271596 COMPLETED PHASE2