AnhedoniaPhase 1/2REPACNCT06017037
REward Processing And Citalopram Study
A Phase 1/2 study testing Citalopram 20mg in people with Anhedonia, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anhedonia
- What is being tested?
- Citalopram 20mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 May 2023to 1 May 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Susannah Murphy, PhD contact
United Kingdom1 site, 1 recruiting
- Recruiting
Neurosciences building, Department of Psychiatry, Warneford hospital
Oxford, Oxfordshire, OX3 7JX
Alexander Smith, 01865618339, Alexander.Smith@psych.ox.ac.uk
Catherine harmer, catherine.harmer@psych.ox.ac.uk
About this study
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:
- Does a subacute increase in serotonin influence the activation regions during reward learning
- 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.
- Conditions
- Anhedonia
- Being tested
- Citalopram 20mg, Placebo
- Medical subject headings
- Anhedonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citalopram 20mgDrug
Citalopram 20mg tablets, encapsulated to aid blinding. To take per oral once daily for 7-9 days
PlaceboDrug
Lactose monohydrate tablets encapsulated to aid blinding. To take per oral once daily for 7-9 days
| Study group | Role | What they receive |
|---|---|---|
| Citalopram | Experimental | Citalopram 20mg p.o. once daily for 7-9 days Receives: Drug: Citalopram 20mg |
| Placebo | Placebo comparator | Lactose p.o. once daily for 7-9 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 7-9 of treatment
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.
Measured: Day 7-9 of treatment
Secondary outcomes (5)
Resting state
Resting state fMRI activation
Measured: Day 7-9 of treatment
Subjective rating of primary reward
Subjective rating of four tastes (sweet, salt, sour \& bitter) in terms of intensity, anticipation of pleasurableness and actual pleasurableness.
Measured: Day 0 and day 7-9 of treatment
Reward & aversive learning: behavioural volatile reward learning task: total money won
Amount of money won/lost \& total amount of money received.
Measured: day 7-9 of treatment
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
- Proportion of offer acceptance for various levels of reward and effort
- proportion of accepted offers successfully obtained
Measured: day 7-9 of treatment
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.
Measured: day 7-9 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start19 May 2023
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnhedoniaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine Harmer, PhD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06017037
- Sponsor's protocol ID
- REPAC01
- Acronym
- REPAC
- Status last verified
- May 2023
- First submitted
- 15 May 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REward Processing And Citalopram Study
- ClinicalTrials.gov ID
- NCT06017037
- Acronym / sponsor ID
- REPAC / REPAC01
- Conditions
- Anhedonia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 19 May 2023 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 30 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does a subacute increase in serotonin influence the activation regions during reward learning
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Citalopram | Experimental | Drug: Citalopram 20mgCitalopram 20mg p.o. once daily for 7-9 days |
| Placebo | Placebo comparator | Drug: PlaceboLactose p.o. once daily for 7-9 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Citalopram 20mgCitalopram 20mg tablets, encapsulated to aid blinding. To take per oral once daily for 7-9 days | Drug | Citalopram |
| PlaceboLactose monohydrate tablets encapsulated to aid blinding. To take per oral once daily for 7-9 days | Drug | Placebo |
Primary outcome
Reward & aversive learning: behavioural correlates
Time frame: Day 7-9 of treatment
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.
Reward & aversive learning: neural correlates
Time frame: Day 7-9 of treatment
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.
5 secondary outcomes
Resting state
Time frame: Day 7-9 of treatment
Subjective rating of primary reward
Time frame: Day 0 and day 7-9 of treatment
Reward & aversive learning: behavioural volatile reward learning task: total money won
Time frame: day 7-9 of treatment
Motivational reward task
Time frame: day 7-9 of treatment
Reward & aversive learning: behavioural volatile reward learning task: learning rate
Time frame: day 7-9 of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susannah Murphy, PhD contact
Catherine Harmer, PhD principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Citalopram 20mg in people with Anhedonia, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander Smith, MBBS (07865 618318, alexander.smith@psych.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reward & aversive learning: behavioural correlates (time frame: Day 7-9 of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.