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

Pain Clinical Trial

Official title:

Effect of Escitalopram vs. Reboxetine on Somatic and Visceral Sensitivity of Patients With Major Depressive Disorder: a Randomized, Double Blind Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00209807
• Other study ID #: PFD-ESC
• Status: Recruiting
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: May 26, 2010
• Start date: September 2005
• Est. completion date: April 2011

Study information

• Verified date: May 2010
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: April 2011
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Pain
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression
• Pain

Intervention

Drug:
• escitalopram
escitalopram 10 mg/d for 6 weeks
• 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.

Locations

Country	Name	City	State
Spain	Hospital Universitari vall d'Hebron	Barcelona	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rectal distension Transcutaneous Electrical Neuro-Stimulation		1-7 weeks	No