Conditions: Non Ulcer Dyspepsia
Keywords: Nonulcer dyspepsia Functional dyspepsia Antidepressant use in dyspepsia Nortriptyline Tricyclic antidepressants
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 5
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine if use of Nortriptyline will improve symptoms and quality of life in patients who have nonulcer dyspepsia.

Detailed description:
Nonulcer dyspepsia is a common complaint in clinical practice and its management should be based on the best evidence. Many clinical trials of nonulcer dyspepsia suffer from important weaknesses in trial design. This makes it difficult to determine whether truly efficacious therapies exist for this disorder.

Once a diagnosis of nonulcer dyspepsia is confirmed by normal endoscopy, a trial of therapy is commonly prescribed. However, the benefits of all therapies in this condition have been questioned. Small studies have suggested benefit in use of antidepressants such as Nortriptyline and even though the data is insufficient, antidepressants such as Nortriptyline are widely used in clinical practice largely due to lack of proven, reliable therapies for nonulcer dyspepsia.

Our hypothesis is that Nortriptyline will improve symptoms of nonulcer dyspepsia and improve quality of life.

Arms:
arm 1: Patients in this group will receive Nortriptyline 25mg at night for 8 weeks. arm 2: Patients in this group will receive an identical placebo capsule at night for 8 weeks.

Interventions: intervention 1: Nortriptyline intervention 2: Placebo
Intervention descriptions: intervention 1: Nortriptyline 25mg capsule, orally administered, every night for 8 weeks intervention 2: An identical placebo capsule containing lactose, administered orally, every night for 8 weeks

Protocol document: