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Effect of Escitalopram vs. Reboxetine on Gastro-Intestinal Sensitivity of Patients With Major Depressive Disorder
This study is currently recruiting participants.
Verified by Hospital Universitari Vall d'Hebron Research Institute, April 2009
First Received: September 13, 2005   Last Updated: April 28, 2009   History of Changes
Sponsored by: Hospital Universitari Vall d'Hebron Research Institute
Information provided by: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT00209807
  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 IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
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: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
subjects with MDD randomized to Escitalopram
Drug: escitalopram
escitalopram 10 mg/d for 6 weeks
2: Active Comparator
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, Catalonia
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: Servei de Psiquiatria. Hospital Universitari Vall d'Hebron ( Miguel Casas Brugué )
Study ID Numbers: PFD-ESC
Study First Received: September 13, 2005
Last Updated: April 28, 2009
ClinicalTrials.gov Identifier: NCT00209807     History of Changes
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

Study placed in the following topic categories:
Neurotransmitter Agents
Depression
Adrenergic Agents
Cholinergic Antagonists
Signs and Symptoms, Digestive
Abdominal Pain
Psychotropic Drugs
Pain
Depressive Disorder, Major
Cholinergic Agents
Depressive Disorder
Serotonin Uptake Inhibitors
Citalopram
Serotonin
Behavioral Symptoms
Muscarinic Antagonists
Signs and Symptoms
Mental Disorders
Mood Disorders
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Dexetimide
Antidepressive Agents
Reboxetine

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

ClinicalTrials.gov processed this record on July 02, 2009