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

Primary Purpose

Major Depression, Pain, Abdominal Pain

Status

Unknown status

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

escitalopram

Reboxetine

No intervention

About this trial

This is an interventional treatment trial for Major Depression focused on measuring major depression, pain, escitalopram, reboxetine, visceral sensitivity, somatic sensitivity

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Hospital Universitari vall d'HebronRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Arm Description

subjects with MDD randomized to Escitalopram

MDD patients receiving reboxetine

Healthy volonteers

Outcomes

Primary Outcome Measures

rectal distension Transcutaneous Electrical Neuro-Stimulation

Secondary Outcome Measures

Full Information

NCT ID

NCT00209807

First Posted

September 13, 2005

Last Updated

May 26, 2010

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT00209807

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2010

Overall Recruitment Status

Unknown status

Study Start Date

September 2005 (undefined)

Primary Completion Date

June 2009 (Anticipated)

Study Completion Date

April 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Hospital Universitari Vall d'Hebron Research Institute

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depression, Pain, Abdominal Pain

Keywords

major depression, pain, escitalopram, reboxetine, visceral sensitivity, somatic sensitivity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

subjects with MDD randomized to Escitalopram

Arm Title

Arm Type

Active Comparator

Arm Description

MDD patients receiving reboxetine

Arm Title

Arm Type

Other

Arm Description

Healthy volonteers

Intervention Type

Drug

Intervention Name(s)

escitalopram

Other Intervention Name(s)

reboxetine

Intervention Description

escitalopram 10 mg/d for 6 weeks

Intervention Type

Drug

Intervention Name(s)

Reboxetine

Intervention Description

Reboxetine 8 mg/d for 6 weeks

Intervention Type

Other

Intervention Name(s)

No intervention

Intervention Description

This group of healthy volonteers will receive no drug and will be a healthy comparator.

Primary Outcome Measure Information:

Title

rectal distension Transcutaneous Electrical Neuro-Stimulation

Time Frame

1-7 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Casas Miguel, Prof.

Organizational Affiliation

Hospital Universitari Vall d'Hebron Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Universitari vall d'Hebron

City

Barcelona

State/Province

Catalonia

ZIP/Postal Code

08036

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Josep Antoni Ramos-Quiroga, MD

Phone

0034 93 489 42 94

jaramos@vhebron.net

First Name & Middle Initial & Last Name & Degree

Xavier Castells, MD

Phone

0034 93 489 42 94

xcc@icf.uab.cat

First Name & Middle Initial & Last Name & Degree

Miguel Casas, Prof

First Name & Middle Initial & Last Name & Degree

Josep Antoni Ramos-Quiroga, MD

First Name & Middle Initial & Last Name & Degree

Juan-R Malagelada, MD

First Name & Middle Initial & Last Name & Degree

Fernando Azpiroz, MD

First Name & Middle Initial & Last Name & Degree

Rosa Bosch Munso

First Name & Middle Initial & Last Name & Degree

Gemma Parramon

First Name & Middle Initial & Last Name & Degree

Xavier Castells Cervelló, MD

First Name & Middle Initial & Last Name & Degree

Anna Accarino, MD

First Name & Middle Initial & Last Name & Degree

Jordi Serra, MD

12. IPD Sharing Statement

Learn more about this trial

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

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