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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00209807
Recruitment Status : Unknown
Verified May 2010 by Hospital Universitari Vall d'Hebron Research Institute.
Recruitment status was:  Recruiting
First Posted : September 21, 2005
Last Update Posted : May 27, 2010
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Major Depression Pain Abdominal Pain Drug: escitalopram Drug: Reboxetine Other: No intervention Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Escitalopram vs. Reboxetine on Somatic and Visceral Sensitivity of Patients With Major Depressive Disorder: a Randomized, Double Blind Clinical Trial
Study Start Date : September 2005
Estimated Primary Completion Date : June 2009
Estimated Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. rectal distension Transcutaneous Electrical Neuro-Stimulation [ Time Frame: 1-7 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00209807

Hospital Universitari vall d'Hebron Recruiting
Barcelona, Catalonia, Spain, 08036
Contact: Josep Antoni Ramos-Quiroga, MD    0034 93 489 42 94    jaramos@vhebron.net   
Contact: Xavier Castells, MD    0034 93 489 42 94    xcc@icf.uab.cat   
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         
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Principal Investigator: Casas Miguel, Prof. Hospital Universitari Vall d'Hebron Research Institute
More Information

Responsible Party: Miguel Casas Brugué, Servei de Psiquiatria. Hospital Universitari Vall d'Hebron
ClinicalTrials.gov Identifier: NCT00209807     History of Changes
Other Study ID Numbers: PFD-ESC
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: May 27, 2010
Last Verified: May 2010

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
major depression
visceral sensitivity
somatic sensitivity

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Abdominal Pain
Behavioral Symptoms
Mood Disorders
Mental Disorders
Immune System Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents