Mirtazapine Versus Placebo in Functional Dyspepsia

Phase 4 Study of Mirtazapine in Functional Dyspepsia Patients With Weight Loss

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

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