Effect of Escitalopram vs. Reboxetine on Gastro-intestinal Sensitivity of Patients With Major Depressive Disorder
NCT00209807 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2010-05-27
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
Interventions
- DRUG
-
escitalopram
escitalopram 10 mg/d for 6 weeks
- DRUG
-
Reboxetine
Reboxetine 8 mg/d for 6 weeks
- OTHER
-
No intervention
This group of healthy volonteers will receive no drug and will be a healthy comparator.
Sponsors & Collaborators
-
Hospital Universitari Vall d'Hebron Research Institute
lead OTHER
Principal Investigators
-
Casas Miguel, Prof. · Hospital Universitari Vall d'Hebron Research Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2005-09-30
- Primary Completion
- 2009-06-30
- Completion
- 2011-04-30
Countries
- Spain
Study Locations
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