Effect of Escitalopram vs. Reboxetine on Gastro-Intestinal Sensitivity of Patients With Major Depressive Disorder - Tabular View

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

April 28, 2009

Start Date ^ICMJE

September 2005

Estimated Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

rectal distension Transcutaneous Electrical Neuro-Stimulation [ Time Frame: 1-7 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00209807 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Effect of Escitalopram vs. Reboxetine on Somatic and Visceral Sensitivity of Patients With Major Depressive Disorder: a Randomized, Double Blind Clinical Trial

Brief Summary

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Major Depression
Pain
Abdominal Pain

Intervention ^ICMJE

Drug: escitalopram
Drug: Reboxetine
Other: No intervention

Study Arms / Comparison Groups

Experimental: subjects with MDD randomized to Escitalopram
Active Comparator: MDD patients receiving reboxetine
Other: Healthy volonteers

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2009

Estimated Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 64 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Location Countries ^ICMJE

Spain

Administrative Information

NCT ID ^ICMJE

NCT00209807

Responsible Party

Miguel Casas Brugué, Servei de Psiquiatria. Hospital Universitari Vall d'Hebron

Study ID Numbers ^ICMJE

PFD-ESC

Study Sponsor ^ICMJE

Hospital Universitari Vall d'Hebron Research Institute

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Casas Miguel, Prof.

Hospital Universitari Vall d'Hebron Research Institute

Information Provided By

Hospital Universitari Vall d'Hebron Research Institute

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP