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

NCT00209807 | Unknown Phase 4

• 1 other identifier: PFD-ESC
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depression; Pain; Abdominal Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• rectal distension Transcutaneous Electrical Neuro-Stimulation

  1-7 weeks

Study Arms (3)

1

EXPERIMENTAL

subjects with MDD randomized to Escitalopram

Drug: escitalopram

2

ACTIVE COMPARATOR

MDD patients receiving reboxetine

Drug: Reboxetine

3

OTHER

Healthy volonteers

Other: No intervention

Interventions

escitalopram DRUG

escitalopram 10 mg/d for 6 weeks

Also known as: reboxetine

1

Reboxetine DRUG

Reboxetine 8 mg/d for 6 weeks

2

No intervention OTHER

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

3

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• MDD according with DSM-IV-TR
• Hamilton depression scale \> 21

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Hospital Universitari vall d'Hebron

Barcelona, Catalonia, 08036, Spain

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Pain; Abdominal Pain

Interventions

Escitalopram; Reboxetine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring

Study Officials

• Casas Miguel, Prof.

  Hospital Universitari Vall d'Hebron Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: September 1, 2005
• Primary Completion: June 1, 2009
• Study Completion: April 1, 2011
• Last Updated: May 27, 2010

Record last verified: 2010-05

Locations

ES (1)