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

Phase 4

• Conditions: Major Depression; Pain; Abdominal Pain
• Interventions: Other: No intervention; Drug: escitalopram; Drug: Reboxetine

• Registration Number: NCT00209807
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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

Not available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2009-06
• Status Verified: 2010-05
• Last Update Submitted: 2010-05-26
• Last Update Posted: 2010-05-27
• Study Completion: 2011-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	No intervention	Healthy volonteers
1	escitalopram	subjects with MDD randomized to Escitalopram
2	Reboxetine	MDD patients receiving reboxetine

Primary Outcome Measures

Name	Time	Method
rectal distension Transcutaneous Electrical Neuro-Stimulation	1-7 weeks

Trial Locations

Locations (1)

Hospital Universitari vall d'Hebron; 🇪🇸 Barcelona, Catalonia, Spain