Clinical trial NCT06212284: Serotonin, Anxiety and Visceral Sensation
Official title: General and Anxiety-Linked Influence of Acute Serotonin Reuptake Inhibition on Neural Responses Associated With Attended Visceral Sensation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: serotonin
interoception
ssri
anxiety
Lead sponsor: University of Sussex
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: 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)

Primary outcomes:
measure: relative neural interoceptive response - heart
timeFrame: 15 minutes
measure: relative neural interoceptive response - stomach
timeFrame: 15 minutes
measure: State Anxiety
timeFrame: 5 minutes
Secondary outcomes:
measure: Metacognitive Interoceptive Insight
timeFrame: 45 minutes
measure: Physiological and Psychological state
timeFrame: Measured twice, for 2 minutes, before and after scanning. Average taken to estimate state inside scanner.
measure: Positive and Negative Affect Scale
timeFrame: Measured twice, for 2 minutes, before and after scanning. Average taken to estimate state inside scanner.
measure: Heartrate
timeFrame: Before scans of each session, 2 minutes
measure: Cerebral Blood Flow Change
timeFrame: 2 minutes, at scan
measure: Anatomical scan and fieldmaps
timeFrame: 6 minutes, at scan
Other outcomes:
Locations:
city: Falmer
country: United Kingdom
facility: School of Psychology
state: East Sussex
Study officials:
affiliation: University of Sussex
name: Daniel Campbell-Meiklejohn, DPhil
role: PRINCIPAL_INVESTIGATOR
References: