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Serotonin, Anxiety and Visceral Sensation

General and Anxiety-Linked Influence of Acute Serotonin Reuptake Inhibition on Neural Responses Associated With Attended Visceral Sensation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06212284
Enrollment
31
Registered
2024-01-18
Start date
2018-02-18
Completion date
2018-11-14
Last updated
2024-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

serotonin, interoception, ssri, anxiety

Brief 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 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.

Interventions

Doses were delivered in gelatine capsules filled with microcrystalline cellulose.

DRUGPlacebo

Doses were gelatine capsules filled with microcrystalline cellulose

Sponsors

University of Sussex
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

\- healthy volunteer

Exclusion criteria

included: * 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)

Design outcomes

Primary

MeasureTime frameDescription
relative neural interoceptive response - heart15 minutesNeural 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 - stomach15 minutesNeural response, inferred via functional magnetic resonance imaging from focusing attention on the stomach, minus the response during focus on a visual stimulus
State Anxiety5 minutesState Trait Anxiety Inventory

Secondary

MeasureTime frameDescription
HeartrateBefore scans of each session, 2 minutesParticipants had their heartrate recorded with the participant relaxed and sitting.
Metacognitive Interoceptive Insight45 minutesAbility of confidence to predict accuracy when making decisions about whether heartbeat is in sync with an auditory tone. This is an exploratory measure.
Anatomical scan and fieldmaps6 minutes, at scanFor coregistration of functional magnetic resonance images
Cerebral Blood Flow Change2 minutes, at scanPerfusion imaging, to control for effects of citalopram on blood flow
Physiological and Psychological stateMeasured twice, for 2 minutes, before and after scanning. Average taken to estimate state inside scanner.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.
Positive and Negative Affect ScaleMeasured twice, for 2 minutes, before and after scanning. Average taken to estimate state inside scanner.Measures affective state, confirming anxiety measure

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026