Major Depression, Pain, Abdominal Pain
Conditions
Keywords
major depression, pain, escitalopram, reboxetine, visceral sensitivity, somatic sensitivity
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.
Interventions
DRUGescitalopram
escitalopram 10 mg/d for 6 weeks
DRUGReboxetine
Reboxetine 8 mg/d for 6 weeks
OTHERNo intervention
This group of healthy volonteers will receive no drug and will be a healthy comparator.
Sponsors
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| rectal distension Transcutaneous Electrical Neuro-Stimulation | 1-7 weeks |
Countries
Spain
Outcome results
None listed