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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2010 by Hospital Universitari Vall d'Hebron Research Institute.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00209807
First Posted: September 21, 2005
Last Update Posted: May 27, 2010
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.
Information provided by:
Hospital Universitari Vall d'Hebron Research Institute
  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 Other: No intervention Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hospital Universitari Vall d'Hebron Research Institute:

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

Estimated Enrollment: 42
Study Start Date: September 2005
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
3
Healthy volonteers
Other: No intervention
This group of healthy volonteers will receive no drug and will be a healthy comparator.

  Eligibility

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
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.
  • 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


Locations
Spain
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
Investigators
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 Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: May 27, 2010
Last Verified: May 2010

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Hypersensitivity
Abdominal Pain
Behavioral Symptoms
Mood Disorders
Mental Disorders
Immune System Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive
Citalopram
Reboxetine
Dexetimide
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
Parasympatholytics