Effect of Escitalopram vs. Reboxetine on Gastro-Intestinal Sensitivity of Patients With Major Depressive Disorder
Information source: Hospital University Vall d'Hebron
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depression; Pain; Abdominal Pain
Intervention: escitalopram (Drug); Reboxetine (Drug); No intervention (Other)
Phase: Phase 4
Status: Recruiting
Sponsored by: Hospital University Vall d'Hebron Official(s) and/or principal investigator(s):
Casas Miguel, Prof., Principal Investigator, Affiliation: Hospital University Vall d'Hebron
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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Primary outcome: rectal distension
Transcutaneous Electrical Neuro-Stimulation
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
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 and Contacts
Hospital Universitari vall d'Hebron, Barcelona, Catalonia 08036, Spain; Recruiting
Josep Antoni Ramos-Quiroga, MD, Phone: 0034 93 489 42 94, Email: jaramos@vhebron.net
Xavier Castells, MD, Phone: 0034 93 489 42 94, Email: xcc@icf.uab.es
Miguel Casas, Prof, Principal Investigator
Josep Antoni Ramos-Quiroga, MD, Sub-Investigator
Juan-R Malagelada, MD, Principal Investigator
Fernando Azpiroz, MD, Sub-Investigator
Rosa Bosch Munso, Sub-Investigator
Gemma Parramon, Sub-Investigator
Xavier Castells Cervelló, MD, Sub-Investigator
Anna Accarino, MD, Sub-Investigator
Jordi Serra, MD, Sub-Investigator
Additional Information
Starting date: September 2005
Ending date: June 2009
Last updated: June 4, 2008
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