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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2011-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Major Depression Pain Abdominal Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

subjects with MDD randomized to Escitalopram

Group Type EXPERIMENTAL

escitalopram

Intervention Type DRUG

escitalopram 10 mg/d for 6 weeks

2

MDD patients receiving reboxetine

Group Type ACTIVE_COMPARATOR

Reboxetine

Intervention Type DRUG

Reboxetine 8 mg/d for 6 weeks

3

Healthy volonteers

Group Type OTHER

No intervention

Intervention Type OTHER

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

Interventions

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escitalopram

escitalopram 10 mg/d for 6 weeks

Intervention Type DRUG

Reboxetine

Reboxetine 8 mg/d for 6 weeks

Intervention Type DRUG

No intervention

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

Intervention Type OTHER

Other Intervention Names

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reboxetine

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes