Functional Dyspepsia | Mirtazapine Versus Placebo in Functional Dyspepsia

Functional Dyspepsia research study

What is the primary objective of this study?

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

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Functional Dyspepsia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:MirtazapineMirtazapine 15 mg daily

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Mirtazapinemirtazapine 15 mg daily

PlaceboPlacebo once daily

Study Status

Unknown status

Start Date: September 2006

Completed Date: December 2011

Phase: Phase 4

Type: Interventional


Primary Outcome: Difference in dyspepsia symptom scores week 8 versus week 0

Secondary Outcome: Individual symptom severities

Study sponsors, principal investigator, and references

Principal Investigator: Jan Tack, M.D., Ph.D.

Lead Sponsor: Universitaire Ziekenhuizen Leuven


More information:

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