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

May 26, 2010 updated by: Hospital Universitari Vall d'Hebron Research Institute

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Catalonia
      • Barcelona, Catalonia, Spain, 08036
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
          • Xavier Castells, MD
          • Phone Number: 0034 93 489 42 94
          • Email: xcc@icf.uab.cat
        • Contact:
        • Principal Investigator:
          • Miguel Casas, Prof
        • Sub-Investigator:
          • Josep Antoni Ramos-Quiroga, MD
        • Principal Investigator:
          • Juan-R Malagelada, MD
        • Sub-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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 62 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
subjects with MDD randomized to Escitalopram
Drug: escitalopram
escitalopram 10 mg/d for 6 weeks
Other Names:
  • reboxetine
Active Comparator: 2
MDD patients receiving reboxetine
Drug: Reboxetine
Reboxetine 8 mg/d for 6 weeks
Other: 3
Healthy volonteers
Other: No intervention
This group of healthy volonteers will receive no drug and will be a healthy comparator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
rectal distension Transcutaneous Electrical Neuro-Stimulation
Time Frame: 1-7 weeks
1-7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Investigators

  • Principal Investigator: Casas Miguel, Prof., Hospital Universitari Vall d'Hebron Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Anticipated)

June 1, 2009

Study Completion (Anticipated)

April 1, 2011

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

May 27, 2010

Last Update Submitted That Met QC Criteria

May 26, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PFD-ESC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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