Serotonin Effect in Functional Dyspepsia

Serotonin Effect in Non-Ulcer Dyspepsia

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

Study Overview

• Status: Completed
• Conditions: Dyspepsia
• Intervention / Treatment: Drug: venlafaxine

Detailed Description

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 will be collected in a 10ml EDTA-tube. Then, each subject will be randomized to treatment with Efexor XR (first and last two weeks 75 mg 1dd and from the third to the fifth week 75 mg 2dd) or identical placebos for 8 weeks. Before starting and after finishing treatment, patients will be asked to fill out a questionnaire on intensity of their gastrointestinal complaints, current quality of life and anxiety and depression.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Arnhem, Netherlands
    • Rijnstate hospital
  • Doetinchem, Netherlands
    • Slingeland Hospital
  • Ede, Netherlands
    • Gelderse Vallei Hospital
  • Nijmegen, Netherlands, 6500 GS
    • Canisius-Wilhelmina Hospital
  • Oss, Netherlands
    • Bernhoven Hospital
  • P.O. Box 9101
    • Nijmegen, P.O. Box 9101, Netherlands, 6500 HB
      • Radboud University Nijmegen Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Persistent upper gastrointestinal symptoms;
• Absence of any serious organic cause of the complaints at previous upper gastrointestinal endoscopy (including gastric ulcer, carcinoma, oesophageal reflux disease, portal hypertension, hernia hiatus >2 cm or severe gastritis);
• Over 18 years of age;
• Written informed consent.

Exclusion Criteria:

• History of bipolar disorder;
• Contra-indication for venlafaxine;
• Current or planned pregnancy or lactation;
• Diagnosed alcoholism, anorexia nervosa or bulimia;
• Current or recent (within the last two weeks) use of a selective serotonin re-uptake inhibitor (SSRI) or MAO-inhibitor;
• Any other condition or circumstance that, in the opinion of the investigator or the physician, would compromise the subject's successful participation in this trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Upper gastrointestinal symptom absence after 6 weeks treatment.

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Investigators: Study Director: Jan Jansen, Professor MD, Radboud University Nijmegen Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2005
• Study Completion (Actual): July 1, 2007

Study Registration Dates

• First Submitted: June 21, 2005
• First Submitted That Met QC Criteria: June 21, 2005
• First Posted (Estimate): June 22, 2005

Study Record Updates

• Last Update Posted (Estimate): September 24, 2007
• Last Update Submitted That Met QC Criteria: September 21, 2007
• Last Verified: September 1, 2007

More Information

Terms related to this study

• Keywords: functional dyspepsia;; Serotonin Uptake Inhibitors;; Antidepressive Agents.
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Antidepressive Agents, Second-Generation; Serotonin and Noradrenaline Reuptake Inhibitors; Venlafaxine Hydrochloride
• Other Study ID Numbers: SEREIN