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:

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:	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