HealthyNCT06212284
Serotonin, Anxiety and Visceral Sensation
A study testing Citalopram 20mg in people with Healthy, run by University of Sussex at 1 site in United Kingdom.
Trial summary
The goal of this crossover study was to learn about the potential regulatory role of serotonin in interoceptive processing and its relationship to levels of state anxiety. This experiment directly compared the impact of a selective serotonin reuptake inhibitor (SSRI) (20mg CITALOPRAM) to that of a PLACEBO on the… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- 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
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Feb 2018to 14 Nov 2018
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteer
Who cannot join
- the presence of significant ongoing medical condition;
- pregnancy or breastfeeding;
- currently taking any medication (excluding contraceptive pill);
- first-degree family history of bipolar disorder;
- an indication of current or historical mental health disorder,
- MRI scanner contraindications (e.g. metallic implants)
- data that is unanalyzable due to movement
- excessive side effects of the drug (e.g. nausea)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: General and Anxiety-Linked Influence of Acute Serotonin Reuptake Inhibition on Neural Responses Associated With Attended Visceral Sensation
The goal of this crossover study was to learn about the potential regulatory role of serotonin in interoceptive processing and its relationship to levels of state anxiety. This experiment directly compared the impact of a selective serotonin reuptake inhibitor (SSRI) (20mg CITALOPRAM) to that of a PLACEBO on the neural processing of ordinary interoceptive sensations and the relationship of these influences to anxious states.
Healthy young volunteers completed the visceral interoceptive attention task with each treatment condition (citalopram and placebo). The task involves focusing attention on heart, stomach, or visual sensation control while scanned with functional magnetic resonance imaging (fMRI). The difference in haemodynamic response between interoceptive sensation(s) and visual sensation (i.e. the relative interoceptive response) is compared between treatment conditions. State anxiety is measured at each test period. It is used to test for a moderating effect of state anxiety on the influence of serotonin in interoceptive processing and used post-hoc to explore associations between changes in state anxiety and changes of interoceptive relative interoceptive response due to the SSRI.
- Conditions
- Healthy
- Being tested
- Citalopram 20mg, Placebo
- Keywords
- serotonin, interoception, ssri, anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citalopram 20mgDrug
Doses were delivered in gelatine capsules filled with microcrystalline cellulose.
PlaceboDrug
Doses were gelatine capsules filled with microcrystalline cellulose
| Study group | Role | What they receive |
|---|---|---|
| citalopram first, placebo second | Other | Citalopram was taken first. Placebo was taken at least 7 days later. Receives: Drug: Citalopram 20mg; Drug: Placebo |
| placebo first, citalopram second | Other | Placebo was taken first. Citalopram was taken at least 7 days later. Receives: Drug: Citalopram 20mg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
relative neural interoceptive response - heart
Neural response, inferred via functional magnetic resonance imaging from focusing attention on the heart, minus the response during focus on a visual stimulus
Measured: 15 minutes
relative neural interoceptive response - stomach
Neural response, inferred via functional magnetic resonance imaging from focusing attention on the stomach, minus the response during focus on a visual stimulus
Measured: 15 minutes
State Anxiety
State Trait Anxiety Inventory
Measured: 5 minutes
Secondary outcomes (6)
Metacognitive Interoceptive Insight
Ability of confidence to predict accuracy when making decisions about whether heartbeat is in sync with an auditory tone. This is an exploratory measure.
Measured: 45 minutes
Physiological and Psychological state
Three scales (from 0-100) were given to assess three somatic side effects (nausea, headache and dizziness). Five anxiety-related effects (pairs of antonyms: alert-drowsy, stimulated-sedated, restless-peaceful, irritable-good-humoured, anxious-calm) were used to confirm other anxiety measures and alert the researchers to excessive side effects. Used to confirm anxiety measure detect side effects.
Measured: Measured twice, for 2 minutes, before and after scanning. Average taken to estimate state inside scanner.
Positive and Negative Affect Scale
Measures affective state, confirming anxiety measure
Measured: Measured twice, for 2 minutes, before and after scanning. Average taken to estimate state inside scanner.
Heartrate
Participants had their heartrate recorded with the participant relaxed and sitting.
Measured: Before scans of each session, 2 minutes
Cerebral Blood Flow Change
Perfusion imaging, to control for effects of citalopram on blood flow
Measured: 2 minutes, at scan
Anatomical scan and fieldmaps
For coregistration of functional magnetic resonance images
Measured: 6 minutes, at scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start18 Feb 2018
- Primary completion13 Nov 2018
- Study completion14 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sussex
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Campbell-Meiklejohn, University of Sussex
- Investigators
- Daniel Campbell-Meiklejohn, DPhil, Principal investigator, University of Sussex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212284
- Sponsor's protocol ID
- ER/JL332/9
- Status last verified
- Jan 2024
- First submitted
- 8 Jan 2024
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data will be shared on a publically accessible database with a link accessible through the official publication.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General and Anxiety-Linked Influence of Acute Serotonin Reuptake Inhibition on Neural Responses Associated With Attended Visceral Sensation
- ClinicalTrials.gov ID
- NCT06212284
- Acronym / sponsor ID
- ER/JL332/9
- Conditions
- Healthy
- Keywords
- serotonin, interoception, ssri, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of SussexUniversity, hospital or other
- Study start
- 18 Feb 2018 (actual)
- Primary completion
- 13 Nov 2018 (actual)
- Study completion
- 14 Nov 2018 (actual)
- First posted
- 18 Jan 2024 (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 crossover study was to learn about the potential regulatory role of serotonin in interoceptive processing and its relationship to levels of state anxiety. This experiment directly compared the impact of a selective serotonin reuptake inhibitor (SSRI) (20mg CITALOPRAM) to that of a PLACEBO on the neural processing of ordinary interoceptive sensations and the relationship of these influences to anxious states.
Healthy young volunteers completed the visceral interoceptive attention task with each treatment condition (citalopram and placebo). The task involves focusing attention on heart, stomach, or visual sensation control while scanned with functional magnetic resonance imaging (fMRI). The difference in haemodynamic response between interoceptive sensation(s) and visual sensation (i.e. the relative interoceptive response) is compared between treatment conditions. State anxiety is measured at each test period. It is used to test for a moderating effect of state anxiety on the influence of serotonin in interoceptive processing and used post-hoc to explore associations between changes in state anxiety and changes of interoceptive relative interoceptive response due to the SSRI.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| citalopram first, placebo second | Other | Drug: Citalopram 20mg, Drug: PlaceboCitalopram was taken first. Placebo was taken at least 7 days later. |
| placebo first, citalopram second | Other | Drug: Citalopram 20mg, Drug: PlaceboPlacebo was taken first. Citalopram was taken at least 7 days later. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy volunteer
Key exclusion criteria (8 listed)
- the presence of significant ongoing medical condition;
- pregnancy or breastfeeding;
- currently taking any medication (excluding contraceptive pill);
- first-degree family history of bipolar disorder;
- an indication of current or historical mental health disorder,
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 20mgDoses were delivered in gelatine capsules filled with microcrystalline cellulose. | Drug | citalopram first, placebo second, placebo first, citalopram second |
| PlaceboDoses were gelatine capsules filled with microcrystalline cellulose | Drug | citalopram first, placebo second, placebo first, citalopram second |
Primary outcome
relative neural interoceptive response - heart
Time frame: 15 minutes
Neural response, inferred via functional magnetic resonance imaging from focusing attention on the heart, minus the response during focus on a visual stimulus
relative neural interoceptive response - stomach
Time frame: 15 minutes
Neural response, inferred via functional magnetic resonance imaging from focusing attention on the stomach, minus the response during focus on a visual stimulus
State Anxiety
Time frame: 5 minutes
State Trait Anxiety Inventory
6 secondary outcomes
Metacognitive Interoceptive Insight
Time frame: 45 minutes
Physiological and Psychological state
Time frame: Measured twice, for 2 minutes, before and after scanning. Average taken to estimate state inside scanner.
Positive and Negative Affect Scale
Time frame: Measured twice, for 2 minutes, before and after scanning. Average taken to estimate state inside scanner.
Heartrate
Time frame: Before scans of each session, 2 minutes
Cerebral Blood Flow Change
Time frame: 2 minutes, at scan
Anatomical scan and fieldmaps
Time frame: 6 minutes, at scan
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Individual participant dataSharing planned: Yes. Anonymized data will be shared on a publically accessible database with a link accessible through the official publication.
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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.
Daniel Campbell-Meiklejohn, DPhil principal investigator
University of Sussex
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 20mg in people with Healthy, run by University of Sussex 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 1 inclusion and 8 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: finished, as of the sponsor's last update on 25 Jan 2024. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relative neural interoceptive response - heart (time frame: 15 minutes). The study lists 3 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 25 Jan 2024.