Nortriptyline for the Treatment of Functional Dyspepsia

Summary

Functional dyspepsia (FD) is a common functional gastrointestinal disorder characterized by upper abdominal discomfort/pain and/or symptoms of meal-related fullness/satiety. There is currently no definitive therapy that is beneficial for all FD patients. Accumulating evidence suggests efficacy of tricyclic antidepressants (TCAs) in FD. However, no firm conclusion can be drawn currently due to the relatively small amount of studies and large heterogeneity between studies. In addition, TCAs are often associated with side effects, which occur early after initiation of therapy preceding the therapeutic effect and often result in discontinuation of the therapy. These side effects are related to drug metabolism, which depend on polymorphisms of the cytochrome P (CYP) enzyme system. It is therefore hypothesized that pre-treatment assessment of CYP genotype and subsequent exclusion of abnormal metabolizers limits the occurrence of side-effects and as such improves compliance and efficacy.

Timeline

Start

2018-09-01

Primary completion

2024-08-01

Completion

2024-08-01

Publications

• Bosch DHCA, Beckers AB, Snijkers JTW, Bosman MHMA, Winkens B, Muris JWM, de Wit N, Brouwers JRBJ, van Hee K, Clemens CHM, Haarhuis BJT, Witteman BJM, Masclee AAM, Keszthelyi D. Tailored Treatment of Functional Dyspepsia With Nortriptyline: A Multicenter, Double-blind, Placebo-controlled Trial. Clin Gastroenterol Hepatol. 2026 Jan 29:S1542-3565(26)00041-8. doi: 10.1016/j.cgh.2026.01.013. Online ahead of print.

Drugs

Indications