Serotonin Effect in Functional Dyspepsia

This study has been completed.
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00115362
First received: June 21, 2005
Last updated: September 21, 2007
Last verified: September 2007
  Purpose

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


Condition Intervention
Dyspepsia
Drug: venlafaxine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Serotonin Effect in Non-Ulcer Dyspepsia

Resource links provided by NLM:


Further study details as provided by Radboud University:

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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 300
Study Start Date: July 2005
Study Completion Date: July 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00115362

Locations
Netherlands
Radboud University Nijmegen Medical Center
Nijmegen, P.O. Box 9101, Netherlands, 6500 HB
Rijnstate Hospital
Arnhem, Netherlands
Slingeland Hospital
Doetinchem, Netherlands
Gelderse Vallei Hospital
Ede, Netherlands
Canisius-Wilhelmina Hospital
Nijmegen, Netherlands, 6500 GS
Bernhoven hospital
Oss, Netherlands
Sponsors and Collaborators
Radboud University
Investigators
Study Director: Jan Jansen, Professor MD Radboud University Nijmegen Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00115362     History of Changes
Other Study ID Numbers: SEREIN
Study First Received: June 21, 2005
Last Updated: September 21, 2007
Health Authority: Netherlands: Dutch Health Care Inspectorate

Keywords provided by Radboud University:
functional dyspepsia;
Serotonin Uptake Inhibitors;
Antidepressive Agents.

Additional relevant MeSH terms:
Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms
Antidepressive Agents
Venlafaxine
Serotonin
Serotonin Agents
Serotonin Uptake Inhibitors
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Receptor Agonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Neurotransmitter Uptake Inhibitors
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on August 28, 2014