Mirtazapine Versus Placebo in Functional Dyspepsia

• Status: Unknown status
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitaire Ziekenhuizen Leuven
• Treatments: Mianserin; Mirtazapine

Criteria

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