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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:
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
  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:


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   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00209807

Locations
Spain
Hospital Universitari vall d'Hebron
Barcelona, Catalonia, Spain, 08036
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 
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:
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

ClinicalTrials.gov processed this record on December 09, 2016