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

This study is currently recruiting participants.

Verified May 2010 by Hospital Universitari Vall d'Hebron Research Institute

First Received on September 13, 2005. Last Updated on May 26, 2010 History of Changes

Sponsor:	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:	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:

MedlinePlus related topics: Abdominal Pain Depression

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Reboxetine Reboxetine mesylate Escitalopram Escitalopram oxalate

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 February 09, 2012