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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 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
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 13, 2005
Last Updated: May 26, 2010
Health Authority: Spain: Spanish Agency of Medicines

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

Additional relevant MeSH terms:
Abdominal Pain
Depression
Depressive Disorder
Depressive Disorder, Major
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Behavioral Symptoms
Mood Disorders
Mental Disorders
Dexetimide
Citalopram
Reboxetine
Antiparkinson Agents
Anti-Dyskinesia Agents
 Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 21, 2013