Mirtazapine Versus Placebo in Functional Dyspepsia

Universitaire Ziekenhuizen KU Leuven35 enrolled

Overview

Double-blind randomized controlled trials of 8 weeks mirtazapine 15 mg daily or placebo, followed by 8 weeks of open-label mirtazapine 15 mg daily

Double-blind randomized controlled trials of 8 weeks mirtazapine 15 mg or placebo, followed by 8 weeks of open-label mirtazapine Two weeks run-in, 8 weeks randomized, 8 weeks open label Assessments include * dyspepsia questionnaire * Nepean dyspepsia index * Daily diary * Vital signs

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Functional Dyspepsia

Interventions

MirtazapineDRUG

Mirtazapine 15 mg daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Functional dyspepsia according to Rome II criteria * Weight loss of \> 5% body weights Exclusion Criteria: * Organic GI pathology * History of upper gi tract surgery * Major depression or anxiety * Use of antidepressants in the last 2 months * Prokinetic drugs or spasmolytic drugs * Analgesic use (except paracetamol) * Pregnancy or lactation

Locations (1)

University Hospitals

Leuven, Flanders, Belgium

Outcomes

Primary Outcomes

Difference in dyspepsia symptom scores week 8 versus week 0

The Dyspepsia Symptom Score is calculated from the dyspepsia symptom severity questionnaire at weeks 0, 4 and 8. The symptom score has been used in previous studies (Tack et al., Gastroenterology 1998).

Time frame: Week 8 compared to week 0

Secondary Outcomes

Individual symptom severities

Individual symptom scores from the dyspepsia symptom score (DSS) which is used as primary endpoint

Time frame: Week 8 compared to week 0

Nepean dyspepsia index for quality of life in functional dyspepsia

Use of the validated NDI.

Time frame: Week 8 compared to week 0

Data from ClinicalTrials.gov

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