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

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00209807
• Collaborator: (none)
• Enrollment: 42
• Location: 1
• Arms: 3
• Duration (Months): 67
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depression; Pain; Abdominal Pain	Drug: escitalopram; Drug: Reboxetine; Other: No intervention	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: Sep 1, 2005
• Anticipated Primary Completion Date: Jun 1, 2009
• Anticipated Study Completion Date: Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 subjects with MDD randomized to Escitalopram	Drug: escitalopram; escitalopram 10 mg/d for 6 weeks; Other Names: reboxetine
Active Comparator: 2 MDD patients receiving reboxetine	Drug: Reboxetine; Reboxetine 8 mg/d for 6 weeks
Other: 3 Healthy volonteers	Other: No intervention; This group of healthy volonteers will receive no drug and will be a healthy comparator.

Outcome Measures

Primary Outcome Measures

1. rectal distension Transcutaneous Electrical Neuro-Stimulation [1-7 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitari vall d'Hebron	Barcelona	Catalonia	Spain	08036

Sponsors and Collaborators

• Hospital Universitari Vall d'Hebron Research Institute

Investigators

• Principal Investigator: Casas Miguel, Prof., Hospital Universitari Vall d'Hebron Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00209807
• Other Study ID Numbers: PFD-ESC
• First Posted: Sep 21, 2005
• Last Update Posted: May 27, 2010
• Last Verified: May 1, 2010

• Keywords provided by , ,: major depression; pain; escitalopram; reboxetine; visceral sensitivity; somatic sensitivity
• Additional relevant MeSH terms: Hypersensitivity; Abdominal Pain; Depression; Depressive Disorder; Depressive Disorder, Major; Citalopram; Reboxetine

Study Results

No Results Posted as of May 27, 2010