Mirtazapine Versus Placebo in Functional Dyspepsia

Universitaire Ziekenhuizen KU Leuven

Status and phase: Completed; Phase 4

Conditions: Functional Dyspepsia

Treatments: Drug: Mirtazapine

Study type: Interventional

Funder types: Other

Identifiers

NCT01240096

S50181

Details and patient eligibility

About

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

Full description

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

Enrollment: 35 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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35 participants in 2 patient groups, including a placebo group

Mirtazapine

Active Comparator group

Description:

mirtazapine 15 mg daily

Treatment:

Drug: Mirtazapine

Placebo

Placebo Comparator group

Description:

Placebo once daily

Treatment:

Drug: Mirtazapine