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Effect of Escitalopram Vs. Reboxetine on Gastro-Intestinal Sensitivity of Patients with Major Depressive Disorder. - Article


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Abdominal Perineal Resection


Clinical Trial: Effect of Escitalopram Vs. Reboxetine on Gastro-Intestinal Sensitivity of Patients with Major Depressive Disorder.

This study is not yet open for patient recruitment.
Verified by Hospital University Vall d''''Hebron September 2005

Sponsored by: Hospital University Vall d''''Hebron
Information provided by: Hospital University Vall d''''Hebron
ClinicalTrials.gov Identifier: NCT00209807

Purpose

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.
Condition Intervention Phase
Major depression
Pain
Abdominal Pain
 Drug: escitalopram (drug)reboxetine (drug)
Phase IV

MedlinePlus related topics:  Abdominal Pain;   Mental Health;   Pain

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

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

Eligibility

Ages Eligible for Study:  18 Years   -   64 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

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.
  • pharmacolical failure of the present depressive episode.
  • pregnancy or nursing.
  • treatment with drugs that may interact with study medication.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00209807


Spain, Catalonia
      Hospital Universitari vall d''''Hebron, Barcelona,  Catalonia,  08036,  Spain
Josep Antoni Ramos-Quiroga, MD  0034 93 489 42 94    jaramos@vhebron.net 
Xavier Castells, MD  0034 93 489 42 94    xcc@icf.uab.es 
Miguel Casas, Prof,  Principal Investigator
Josep Antoni Ramos-Quiroga, MD,  Sub-Investigator
Juan-R Malagelada, MD,  Principal Investigator
Fernando Azpiroz, MD,  Sub-Investigator
Rosa Bosch Munso,  Sub-Investigator
Gemma Parramon,  Sub-Investigator
Xavier Castells Cervelló, MD,  Sub-Investigator
Anna Accarino, MD,  Sub-Investigator
Jordi Serra, MD,  Sub-Investigator

Study chairs or principal investigators

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

More Information

Study ID Numbers:  PFD-ESC
Last Updated:  September 20, 2005
Record first received:  September 13, 2005
ClinicalTrials.gov Identifier:  NCT00209807
Health Authority: Spain: Spanish Agency of Medicines
ClinicalTrials.gov processed this record on 2005-09-27


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October 7, 2008



Page Updated: October 1, 2005
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