Effect of Escitalopram vs. Reboxetine on Gastro-intestinal Sensitivity of Patients With Major Depressive Disorder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Hospital Universitari Vall d'Hebron Research Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT00209807
First received: September 13, 2005
Last updated: May 26, 2010
Last verified: May 2010

September 13, 2005
May 26, 2010
September 2005
June 2009   (final data collection date for primary outcome measure)
rectal distension Transcutaneous Electrical Neuro-Stimulation [ Time Frame: 1-7 weeks ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00209807 on ClinicalTrials.gov Archive Site
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Effect of Escitalopram vs. Reboxetine on Gastro-intestinal Sensitivity of Patients With Major Depressive Disorder
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.

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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Major Depression
  • Pain
  • Abdominal Pain
  • Drug: escitalopram
    escitalopram 10 mg/d for 6 weeks
    Other Name: reboxetine
  • 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.
  • Experimental: 1
    subjects with MDD randomized to Escitalopram
    Intervention: Drug: escitalopram
  • Active Comparator: 2
    MDD patients receiving reboxetine
    Intervention: Drug: Reboxetine
  • 3
    Healthy volonteers
    Intervention: Other: No intervention
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
42
April 2011
June 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 64 Years
Yes
Not Provided
Spain
 
NCT00209807
PFD-ESC
Not Provided
Miguel Casas Brugué, Servei de Psiquiatria. Hospital Universitari Vall d'Hebron
Hospital Universitari Vall d'Hebron Research Institute
Not Provided
Principal Investigator: Casas Miguel, Prof. Hospital Universitari Vall d'Hebron Research Institute
Hospital Universitari Vall d'Hebron Research Institute
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP