Clinical Trial: Serotonin Effect in Functional Dyspepsia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Serotonin Effect in Non-Ulcer Dyspepsia

Brief Summary: The purpose of this study is to investigate whether Efexor (venlafaxine) is effective in the treatment of functional dyspepsia.

Detailed Summary:

BACKGROUND: A good 60% of patients presenting with upper abdominal complaints have functional dyspepsia. Usually, acid-suppressive drugs are given as first-line therapy for upper gastrointestinal symptoms. However, results are often not satisfying and symptoms persist. Since many patients with functional gastrointestinal diseases are more anxious and depressed in comparison to healthy controls, several studies investigated the use of antidepressant agents in these patients. Although many studies were underpowered, promising results were obtained with tricyclic antidepressant and mianserin in patients with irritable bowel syndrome. There is still a need for a placebo controlled study with antidepressants in patients with functional dyspepsia.

OBJECTIVE: To investigate the effectiveness of venlafaxine, a selective serotonin and norepinephrine reuptake inhibitor, for treatment of patients with functional dyspepsia.

STUDY DESIGN: A randomized, double blind, placebo controlled trial.

STUDY POPULATION: Consecutive patients with persistent upper GI symptoms without abnormalities at upper gastrointestinal endoscopy.

PRIMARY ENDPOINTS: Upper gastrointestinal symptom absence after 6 weeks treatment.

SECONDARY ENDPOINTS:

  • Anxiety and depression after venlafaxine treatment;
  • Health related quality of life after venlafaxine treatment;
  • The association between serotonin transporter protein and 5-HT receptor polymorphisms and efficacy of venlafaxine.

STUDY PROCEDURE: A venous blood sample
Sponsor: Radboud University

Current Primary Outcome: Upper gastrointestinal symptom absence after 6 weeks treatment.

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Anxiety and depression after venlafaxine treatment
  • Health related quality of life after venlafaxine treatment
  • The association between serotonin transporter protein and 5-HT receptor polymorphisms and efficacy of venlafaxine.


Original Secondary Outcome: Same as current

Information By: Radboud University

Dates:
Date Received: June 21, 2005
Date Started: July 2005
Date Completion:
Last Updated: September 21, 2007
Last Verified: September 2007