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

Phase 4UnknownNCT00209807

Hospital Universitari Vall d'Hebron Research Institute42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Major Depression Pain Abdominal Pain

Interventions

escitalopram 10 mg/d for 6 weeks

ReboxetineDRUG

Reboxetine 8 mg/d for 6 weeks

No interventionOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Universitari vall d'Hebron

Barcelona, Catalonia, Spain

RECRUITING

Outcomes

Primary Outcomes

rectal distension Transcutaneous Electrical Neuro-Stimulation

Time frame: 1-7 weeks

Data from ClinicalTrials.gov

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