NCT02153567

SSRI Study for Functional Dyspepsia (SS)

Completed Phase 3 Last updated 31 January 2019

What this trial tests

Phase 3 trial testing Escitalopram in Dyspepsia in 71 participants. Completed in 9 January 2019.

Timeline

6 December 2013

Primary endpoint
31 December 2018

9 January 2019

Quick facts

Lead sponsor	Chinese University of Hong Kong
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	71
Start date	6 December 2013
Primary completion	31 December 2018
Estimated completion	9 January 2019
Sites	1 location across Hong Kong

Drugs / interventions tested

• Escitalopram (escitalopram) — full drug profile →
• Placebo

Conditions studied

• Dyspepsia — all drugs for Dyspepsia →
• Anxiety — all drugs for Anxiety →
• Depression — all drugs for Depression →

Sponsor

Chinese University of Hong Kong

Who can join

Adults 18 to 60, any sex, with Dyspepsia or Anxiety. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

Functional dyspepsia is one of the commonest digestive disorders. The pathophysiology of functional dyspepsia (FD) is uncertain. Clinical experience and community studies show that FD is strongly associated with common mood disorders especially depression and anxiety disorders, which can be treated with serotonin selective uptake receptor (SSRI).

Our previous study shows that the relief of FD symptom has an association with the change of plasma serotonin and ghrelin profile. However, the correlation between plasma serotonin level in FD patients treated with SSRI is lacking in these studies.

Indication:

Functional dyspepsia patients

Study center(s):

Prince of Wales Hospital, Hong Kong

Aims :

* To evaluate the effect of SSRI treatment on change of plasma serotonin level
* To evaluate the relationship between dyspeptic symptom and change of plasma serotonin level

Study medication:

Escitalopram (Lexapro) 5mg daily for first 2 weeks, and then 10 mg daily for 8 weeks versus Placebo for 10 weeks

Study design:

Double-blind randomized placebo-controlled trial

Number of subjects:72

\- 36 patients (18 male and 18 female) and 36 age-and-sex-matched healthy controls

Patient population:

Functional dyspepsia patients age 18-60, with element of anxiety or depression

Duration of study: 1 June 2013 - 30 November 2015

Primary variable(s):

Change of serotonin and ghrelin level in blood plasma after medication treatment

Secondary variable(s):

Rate of adequate relief using global symptom assessment and symptom scores

Number of visits: 2

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.