MedPath

Serotonin, Anxiety and Visceral Sensation

Not Applicable
Completed
Conditions
Healthy
Interventions
Registration Number
NCT06212284
Lead Sponsor
University of Sussex
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
31
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)
Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
citalopram first, placebo secondCitalopram 20mgCitalopram was taken first. Placebo was taken at least 7 days later.
citalopram first, placebo secondPlaceboCitalopram was taken first. Placebo was taken at least 7 days later.
placebo first, citalopram secondPlaceboPlacebo was taken first. Citalopram was taken at least 7 days later.
placebo first, citalopram secondCitalopram 20mgPlacebo was taken first. Citalopram was taken at least 7 days later.
Primary Outcome Measures
NameTimeMethod
relative neural interoceptive response - heart15 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 - stomach15 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 Anxiety5 minutes

State Trait Anxiety Inventory

Secondary Outcome Measures
NameTimeMethod
Metacognitive Interoceptive Insight45 minutes

Ability of confidence to predict accuracy when making decisions about whether heartbeat is in sync with an auditory tone. This is an exploratory measure.

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.

Cerebral Blood Flow Change2 minutes, at scan

Perfusion imaging, to control for effects of citalopram on blood flow

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

HeartrateBefore scans of each session, 2 minutes

Participants had their heartrate recorded with the participant relaxed and sitting.

Anatomical scan and fieldmaps6 minutes, at scan

For coregistration of functional magnetic resonance images

Trial Locations

Locations (1)

School of Psychology

🇬🇧

Falmer, East Sussex, United Kingdom

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