Molecular Mechanisms of Pharmacological ActionNCT04169230
Citalopram and Self Emotional Processing
A study testing Citalopram in people with Molecular Mechanisms of Pharmacological Action and Depression, run by University of Oxford at 1 site in United Kingdom.
Trial summary
This study is investigating the effect of an acute dose of citalopram on emotional processing about the self. Using a parallel-group double-blind design, participants will be randomised to receive either an acute dose of citalopram or placebo. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Molecular Mechanisms of Pharmacological Action, Depression, Depressive Disorder
- What is being tested?
- Citalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Oct 2019to Sep 2020
- Phase
- Interventional
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or Female
- Aged 18 -45 years
- Fluent in written and spoken English at a sufficient level to understand and complete the tasks
- Body Mass Index (BMI) 18-30
- Participant is willing and able to give informed consent for participation in the study
- Not currently taking any regular medications (expect the contraceptive pill)
Who cannot join
- Any past or current Axis 1 DSM-V psychiatric disorder
- Current use of psychoactive medication (except the contraceptive pill, the Depo-Provera injection or the progesterone implant)
- Current or past history of drug or alcohol dependency
- History of current significant neurological condition (e.g. epilepsy)
- Known hypersensitivity to the study drug
- Currently pregnant or breast feeding
Show all 12Show fewer
- Previous participation in a study that uses the same or similar computer tasks as those used in the present study
- Previous participation in a study that involves the use of a medication within the last three months
- Significant medical condition
- Smokers consuming > 5 cigarettes per day
- Individuals consuming > 6 caffeinated drinks per day
- Lactose Intolerance (due to the study involving administration of a lactose placebo tablet)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Oxford
Oxford, OX3 7JX
Susannah Murphy, DPhil, 01865 618313 ext. +44, susannah.murphy@psych.ox.ac.uk
About this study
Official title: The Effect of Acute Citalopram on Self-referential Emotional Processing and Social Cognition in Healthy Volunteers
This study is investigating the effect of an acute dose of citalopram on emotional processing about the self. Using a parallel-group double-blind design, participants will be randomised to receive either an acute dose of citalopram or placebo. Participants will then complete a number of widely used computer-based cognitive tasks measuring emotional processing biases towards the self.
This study has also been registered on OSF: https://osf.io/nhjvs/?view_only=b39c49bddfd543b99b627dc992e49b45
Read the detailed description
Antidepressants are thought to operate by changing the way patients process emotional information. After a single dose of citalopram or fluoxetine healthy volunteers have been found to display an increased recognition of happy facial expressions and a reduced recognition of sad faces, in the absence of changes in mood. Studies using depressed participants have produced similar results. However, there has been comparatively little research on changes in emotional processing biases about the self following antidepressant administration. Sense of self has been proposed as fundamental for mental health, with self-schemas acting as a focus through which valence and reward influenced perception, memory and decision-making. Antidepressants may increase learning of positive information about the self, potentially remediating negative self-schema and subsequently reducing depression symptoms.
In this study, the investigators aim to examine whether acute administration of citalopram is associated with an increase in positive emotional learning biases about the self. Using a parallel-group double-blind design, participants will be randomised to receive either an acute dose of citalopram or placebo. Participants will then complete a number of widely used computer-based cognitive tasks measuring emotional processing biases. Identifying early changes in cognition and behaviour following antidepressant treatment will increase our knowledge of how antidepressants operate, and provide putative targets to identify early response to antidepressants.
This study has also been registered on OSF: https://osf.io/nhjvs/?view_only=b39c49bddfd543b99b627dc992e49b45
Starting from the 8th November 2019 an additional task (the Oxford Cognition Stress Task (OCST)) was included in the test battery. This task has been developed by the Psychopharmacology and Emotion Research Laboratory (PERL), Department of Psychiatry, University of Oxford. This is an acute psychosocial stress induction paradigm, comprised of computerised cognitive tasks with an induced failure component. An algorithm varies task timing/difficulty to be just beyond participants' ability, accompanied by aversive feedback. The OCST induces mild, transient increases in stress and arousal, as indexed by heart rate, skin conductance, salivary cortisol and self-reported subjective state measures. Data for this task will be collected, analysed and published by PERL and will not be included in any publications relating to the previous registration for this study. The OCST task has been included at the end of the test battery and is therefore not expected to influence data relating to any self-report measures or tasks outlined in the previous registration
This section of the study has been registered separately on ClinicalTrials.gov (titled 'Citalopram and Stress Reactivity') to reflect the separate research questions and study team involvement.
- Conditions
- Molecular Mechanisms of Pharmacological Action, Depression, Depressive Disorder, Mental Disorder, Antidepressive Agents, Cognition
- Being tested
- Citalopram, Placebo oral tablet
- Keywords
- Citalopram, Emotional Processing, Antidepressants, Self Processing, Healthy Volunteers
- Medical subject headings
- Depression, Depressive Disorder, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CitalopramDrug
Single dose administration of citalopram (20mg)
Placebo oral tabletDrug
Single dose administration lactose placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Citalopram | Experimental | Single acute oral dose 20 mg Citalopram (tablet encapsulated in opaque capsule) Receives: Drug: Citalopram |
| Placebo | Placebo comparator | Single acute oral dose Lactose Placebo (tablet encapsulated in opaque capsule) Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Evaluation Learning Task: Bias Scores
An overall index of positive or negative bias will be calculated for each referential condition (self, friend, stranger) using errors to criterion (the number of errors made before 8 rule-congruent responses). Bias is calculated by subtracting errors to criterion made when learning the dislike rule from errors to criterion made when learning the like rule. A positive value indicates a negative bias, as fewer errors are made learning the dislike rule compared to the like rule. Conversely, a negative value indicates a positive bias, as fewer errors are made learning the like rule compared to the dislike rule. The minimum possible value is - 24 (complete bias towards being liked), and the maximum value is + 24 (complete bias towards being disliked).
Measured: Day 1: 3-5.5 hours post drug administration
Associative Learning Task: Reaction Times (ms)
Mean reaction times will be calculated for each referential condition (self, friend, stranger), reward condition (high, medium, low) and valence condition (positive, neutral, negative) for each respective task.
Measured: Day 1: 3-5.5 hours post drug administration
Associative Learning Task: Accuracy (% correct)
Mean accuracy will be calculated for each referential condition (self, friend, stranger), reward condition (high, medium, low) and valence condition (positive, neutral, negative) for each respective task.
Measured: Day 1: 3-5.5 hours post drug administration
Self-Esteem Go/No-Go Association Task: d'
Discriminative accuracy (d') will be calculated through applying Z-score transformations, and subtracting hit z-scores from false alarm z-scores. Z-scores are adjusted by adding or subtracting .005 if hit or false-alarm rates are 0 or 1. d' -values can then be compared for each possible categorical combination to examine implicit self-biases.
Measured: Day 1: 3-5.5 hours post drug administration
Secondary outcomes (5)
Prisoner's Dilemma: Cooperative Behaviours (%)
The main outcome for this task is the proportion of rounds on which participants choose to cooperate. The conditional probability of cooperating will be calculated according to the proportion of rounds on which participants cooperated following each of the four possible outcomes.
Measured: Day 1: 3-5.5 hours post drug administration
Prisoner's Dilemma: Reaction Times (ms)
Reaction times for cooperation versus non-cooperation choices will be calculated.
Measured: Day 1: 3-5.5 hours post drug administration
Emotional Categorisation and Recall: Number of words categorised
The mean number of positive and negative words categorised as describing or not describing the participant/the other will be recorded.
Measured: Day 1: 3-5.5 hours post drug administration
Emotional Categorisation and Recall: Hits
Mean hits will be collected for each referential condition and valence.
Measured: Day 1: 3-5.5 hours post drug administration
Emotional Categorisation and Recall: False Alarms
Mean alse intrusions will be collected for each referential condition and valence.
Measured: Day 1: 3-5.5 hours post drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start11 Oct 2019
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molecular Mechanisms of Pharmacological ActionStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Following the screening, eligible participants will be randomised to receive either a single 20mg oral dose of citalopram or a matched lactose placebo tablet using an online randomisation tool. Note that the study is not assessing the safety or efficacy of citalopram, but rather using it as a probe to understand the role of serotonin in self-referential emotional processing biases.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bath
- Responsible party
- Sponsor
- Investigators
- Catherine Harmer, DPhil, Principal investigator, University of OxfordKatherine S Button, PhD, Principal investigator, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04169230
- Sponsor's protocol ID
- Acute_Citalopram
- Status last verified
- Nov 2019
- First submitted
- 12 Nov 2019
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: An anonymised dataset will be published as open access data on a secure online repository, such as Open Science Framework (https://osf.io/). Participant IDs will be randomly reassigned in this dataset to ensure complete removal of any linkage between anonymised and personal data. Self-report questionnaire data and task outcomes will be included.
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acute Citalopram on Self-referential Emotional Processing and Social Cognition in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04169230
- Acronym / sponsor ID
- Acute_Citalopram
- Conditions
- Molecular Mechanisms of Pharmacological Action, Depression, Depressive Disorder, Mental Disorder, Antidepressive Agents, Cognition
- Keywords
- Citalopram, Emotional Processing, Antidepressants, Self Processing, Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- University of Bath
- Study start
- 11 Oct 2019 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 19 Nov 2019 (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.
This study is investigating the effect of an acute dose of citalopram on emotional processing about the self. Using a parallel-group double-blind design, participants will be randomised to receive either an acute dose of citalopram or placebo. Participants will then complete a number of widely used computer-based cognitive tasks measuring emotional processing biases towards the self.
This study has also been registered on OSF: https://osf.io/nhjvs/?view_only=b39c49bddfd543b99b627dc992e49b45
Detailed description
Antidepressants are thought to operate by changing the way patients process emotional information. After a single dose of citalopram or fluoxetine healthy volunteers have been found to display an increased recognition of happy facial expressions and a reduced recognition of sad faces, in the absence of changes in mood. Studies using depressed participants have produced similar results. However, there has been comparatively little research on changes in emotional processing biases about the self following antidepressant administration. Sense of self has been proposed as fundamental for mental health, with self-schemas acting as a focus through which valence and reward influenced perception, memory and decision-making. Antidepressants may increase learning of positive information about the self, potentially remediating negative self-schema and subsequently reducing depression symptoms.
In this study, the investigators aim to examine whether acute administration of citalopram is associated with an increase in positive emotional learning biases about the self. Using a parallel-group double-blind design, participants will be randomised to receive either an acute dose of citalopram or placebo. Participants will then complete a number of widely used computer-based cognitive tasks measuring emotional processing biases. Identifying early changes in cognition and behaviour following antidepressant treatment will increase our knowledge of how antidepressants operate, and provide putative targets to identify early response to antidepressants.
This study has also been registered on OSF: https://osf.io/nhjvs/?view_only=b39c49bddfd543b99b627dc992e49b45
Starting from the 8th November 2019 an additional task (the Oxford Cognition Stress Task (OCST)) was included in the test battery. This task has been developed by the Psychopharmacology and Emotion Research Laboratory (PERL), Department of Psychiatry, University of Oxford. This is an acute psychosocial stress induction paradigm, comprised of computerised cognitive tasks with an induced failure component. An algorithm varies task timing/difficulty to be just beyond participants' ability, accompanied by aversive feedback. The OCST induces mild, transient increases in stress and arousal, as indexed by heart rate, skin conductance, salivary cortisol and self-reported subjective state measures. Data for this task will be collected, analysed and published by PERL and will not be included in any publications relating to the previous registration for this study. The OCST task has been included at the end of the test battery and is therefore not expected to influence data relating to any self-report measures or tasks outlined in the previous registration
This section of the study has been registered separately on ClinicalTrials.gov (titled 'Citalopram and Stress Reactivity') to reflect the separate research questions and study team involvement.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Following the screening, eligible participants will be randomised to receive either a single 20mg oral dose of citalopram or a matched lactose placebo tablet using an online randomisation tool. Note that the study is not assessing the safety or efficacy of citalopram, but rather using it as a probe to understand the role of serotonin in self-referential emotional processing biases.
| Arm | Type | Receives |
|---|---|---|
| Citalopram | Experimental | Drug: CitalopramSingle acute oral dose 20 mg Citalopram (tablet encapsulated in opaque capsule) |
| Placebo | Placebo comparator | Drug: Placebo oral tabletSingle acute oral dose Lactose Placebo (tablet encapsulated in opaque capsule) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or Female
- Aged 18 -45 years
- Fluent in written and spoken English at a sufficient level to understand and complete the tasks
- Body Mass Index (BMI) 18-30
- Participant is willing and able to give informed consent for participation in the study
Key exclusion criteria (12 listed)
- Any past or current Axis 1 DSM-V psychiatric disorder
- Current use of psychoactive medication (except the contraceptive pill, the Depo-Provera injection or the progesterone implant)
- Current or past history of drug or alcohol dependency
- History of current significant neurological condition (e.g. epilepsy)
- Known hypersensitivity to the study drug
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 |
|---|---|---|
| CitalopramSingle dose administration of citalopram (20mg) | Drug | Citalopram |
| Placebo oral tabletSingle dose administration lactose placebo tablet | Drug | Placebo |
Primary outcome
Social Evaluation Learning Task: Bias Scores
Time frame: Day 1: 3-5.5 hours post drug administration
An overall index of positive or negative bias will be calculated for each referential condition (self, friend, stranger) using errors to criterion (the number of errors made before 8 rule-congruent responses). Bias is calculated by subtracting errors to criterion made when learning the dislike rule from errors to criterion made when learning the like rule. A positive value indicates a negative bias, as fewer errors are made learning the dislike rule compared to the like rule. Conversely, a negative value indicates a positive bias, as fewer errors are made learning the like rule compared to the dislike rule. The minimum possible value is - 24 (complete bias towards being liked), and the maximum value is + 24 (complete bias towards being disliked).
Associative Learning Task: Reaction Times (ms)
Time frame: Day 1: 3-5.5 hours post drug administration
Mean reaction times will be calculated for each referential condition (self, friend, stranger), reward condition (high, medium, low) and valence condition (positive, neutral, negative) for each respective task.
Associative Learning Task: Accuracy (% correct)
Time frame: Day 1: 3-5.5 hours post drug administration
Mean accuracy will be calculated for each referential condition (self, friend, stranger), reward condition (high, medium, low) and valence condition (positive, neutral, negative) for each respective task.
Self-Esteem Go/No-Go Association Task: d'
Time frame: Day 1: 3-5.5 hours post drug administration
Discriminative accuracy (d') will be calculated through applying Z-score transformations, and subtracting hit z-scores from false alarm z-scores. Z-scores are adjusted by adding or subtracting .005 if hit or false-alarm rates are 0 or 1. d' -values can then be compared for each possible categorical combination to examine implicit self-biases.
5 secondary outcomes
Prisoner's Dilemma: Cooperative Behaviours (%)
Time frame: Day 1: 3-5.5 hours post drug administration
Prisoner's Dilemma: Reaction Times (ms)
Time frame: Day 1: 3-5.5 hours post drug administration
Emotional Categorisation and Recall: Number of words categorised
Time frame: Day 1: 3-5.5 hours post drug administration
Emotional Categorisation and Recall: Hits
Time frame: Day 1: 3-5.5 hours post drug administration
Emotional Categorisation and Recall: False Alarms
Time frame: Day 1: 3-5.5 hours post drug administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- PERL OxfordLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. An anonymised dataset will be published as open access data on a secure online repository, such as Open Science Framework (https://osf.io/). Participant IDs will be randomly reassigned in this dataset to ensure complete removal of any linkage between anonymised and personal data. Self-report questionnaire data and task outcomes will be included.
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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.
Catherine Harmer, DPhil principal investigator
University of Oxford
Katherine S Button, PhD principal investigator
University of Bath
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Citalopram in people with Molecular Mechanisms of Pharmacological Action and Depression, 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 6 inclusion and 12 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 19 Nov 2019. 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.
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 Catherine Hobbs, MSc (01865618335 ext. +44, c.hobbs@bath.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Evaluation Learning Task: Bias Scores (time frame: Day 1: 3-5.5 hours post drug administration). The study lists 4 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 19 Nov 2019.