Serotonin, Anxiety and Visceral Sensation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-18

Study Completion Date

2018-11-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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citalopram first, placebo second

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

Group Type OTHER

Citalopram 20mg

Intervention Type DRUG

Doses were delivered in gelatine capsules filled with microcrystalline cellulose.

Placebo

Intervention Type DRUG

Doses were gelatine capsules filled with microcrystalline cellulose

placebo first, citalopram second

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

Group Type OTHER

Citalopram 20mg

Intervention Type DRUG

Doses were delivered in gelatine capsules filled with microcrystalline cellulose.

Placebo

Intervention Type DRUG

Doses were gelatine capsules filled with microcrystalline cellulose

Interventions

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Citalopram 20mg

Doses were delivered in gelatine capsules filled with microcrystalline cellulose.

Intervention Type DRUG

Placebo

Doses were gelatine capsules filled with microcrystalline cellulose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- healthy volunteer

Exclusion Criteria

* 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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes