Official Title: “Effect of Escitalopram vs. Reboxetine on Somatic and Visceral Sensitivity of Patients With Major Depressive Disorder: a Randomized, Double Blind Clinical Trial”

Patients with major depressive disorder (MDD) commonly have many gastrointestinal complaints.

Gastrointestinal pain is classified into 2 categories: visceral and somatic pain. The main aim of this study is to compare somatic and visceral sensitivity between healthy people and pateints with MDD. These two sensitivities will be assessed by the 2 following tests:

standardized rectal distension and Transdermal transcutaneous electric nerve stimulation.

Thereafter, patients with MDD will be randomly allocated to escitalopram or reboxetine. After 6 weeks of treatment, somatic and visceral sensitivity will be reassessed.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: June 2009

Intervention(s) in this Clinical Trial

• Drug: escitalopram
  • escitalopram 10 mg/d for 6 weeks
• Drug: Reboxetine
  • Reboxetine 8 mg/d for 6 weeks
• Other: No intervention
  • This group of healthy volonteers will receive no drug and will be a healthy comparator.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • subjects with MDD randomized to Escitalopram
• Active Comparator: 2
  • MDD patients receiving reboxetine
• Other: 3
  • Healthy volonteers

Primary Measures

• rectal distension Transcutaneous Electrical Neuro-Stimulation
  • Time Frame: 1-7 weeks
    Safety Issue?: No

Inclusion Criteria:

• MDD according with DSM-IV-TR
• Hamilton depression scale > 21

Exclusion Criteria:

• history of gastrointestinal illness
• history of escitalopram, citalopram or reboxetine allergy.
• history of escitalopram, citalopram or reboxetine resistant depression.
• other axis I psychiatric disorder.
• a punctuation > 2 on the suicide item of the Ham-D.
• history of ECT during the past 6 months.
• pharmacological failure of the present depressive episode.
• pregnancy or nursing.
• treatment with drugs that may interact with study medication.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 64 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Hospital University Vall d'Hebron

Overall Clinical Trial Officials and Contacts

Casas Miguel, Prof. Principal Investigator Hospital University Vall d'Hebron  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00209807

Study ID Number: PFD-ESC

ClinicalTrials.gov Identifier: NCT00209807

Health Authority: Spain: Spanish Agency of Medicines