Serotonin, Anxiety and Visceral Sensation

NCT06212284 | Completed

• 1 other identifier: ER/JL332/9
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

serotonin; interoception; ssri; anxiety

Outcome Measures

Primary Outcomes (3)

• 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

  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

  15 minutes

• State Anxiety

  State Trait Anxiety Inventory

  5 minutes

Secondary Outcomes (6)

• Metacognitive Interoceptive Insight

  45 minutes

• Physiological and Psychological state

  Measured twice, for 2 minutes, before and after scanning. Average taken to estimate state inside scanner.

• Positive and Negative Affect Scale

  Measured twice, for 2 minutes, before and after scanning. Average taken to estimate state inside scanner.

• Heartrate

  Before scans of each session, 2 minutes

• Cerebral Blood Flow Change

  2 minutes, at scan

Study Arms (2)

citalopram first, placebo second

OTHER

Citalopram was taken first. Placebo was taken at least 7 days later.

Drug: Citalopram 20mg; Drug: Placebo

placebo first, citalopram second

OTHER

Placebo was taken first. Citalopram was taken at least 7 days later.

Drug: Citalopram 20mg; Drug: Placebo

Interventions

Citalopram 20mg DRUG

Doses were delivered in gelatine capsules filled with microcrystalline cellulose.

citalopram first, placebo second; placebo first, citalopram second

Placebo DRUG

Doses were gelatine capsules filled with microcrystalline cellulose

citalopram first, placebo second; placebo first, citalopram second

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- healthy volunteer

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Sussex: lead

Study Sites (1)

School of Psychology

Falmer, East Sussex, BN1 9QH, United Kingdom

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Citalopram

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Daniel Campbell-Meiklejohn, DPhil

  University of Sussex

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 18, 2024
• Study Start: February 18, 2018
• Primary Completion: November 13, 2018
• Study Completion: November 14, 2018
• Last Updated: January 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: After publication
• Access Criteria: Public Access

Locations

GB (1)