Major DepressionPhase 4NCT00209807
Effect of Escitalopram vs. Reboxetine on Gastro-intestinal Sensitivity of Patients With Major Depressive Disorder
A Phase 4 study testing escitalopram and Reboxetine in people with Major Depression and Pain, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depression, Pain, Abdominal Pain
- What is being tested?
- escitalopram and Reboxetine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2005to Apr 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- MDD according with DSM-IV-TR
- Hamilton depression scale > 21
Who cannot join
- 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.
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- pharmacological failure of the present depressive episode.
- pregnancy or nursing.
- treatment with drugs that may interact with study medication.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari vall d'Hebron
Barcelona, Catalonia, 08036
Josep Antoni Ramos-Quiroga, MD, 0034 93 489 42 94, jaramos@vhebron.net
Xavier Castells, MD, 0034 93 489 42 94, xcc@icf.uab.cat
About this study
Official title: Effect of Escitalopram vs. Reboxetine on Somatic and Visceral Sensitivity of Patients With Major Depressive Disorder: a Randomized, Double Blind Clinical Trial
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
- Major Depression, Pain, Abdominal Pain
- Being tested
- escitalopram, Reboxetine, No intervention
- Keywords
- major depression, pain, escitalopram, reboxetine, visceral sensitivity, somatic sensitivity
- Medical subject headings
- Depressive Disorder, Major, Pain, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
escitalopramDrug
Also called reboxetine
escitalopram 10 mg/d for 6 weeks
ReboxetineDrug
Reboxetine 8 mg/d for 6 weeks
No interventionOther
This group of healthy volonteers will receive no drug and will be a healthy comparator.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | subjects with MDD randomized to Escitalopram Receives: Drug: escitalopram |
| 2 | Active comparator | MDD patients receiving reboxetine Receives: Drug: Reboxetine |
| 3 | Other | Healthy volonteers Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
rectal distension Transcutaneous Electrical Neuro-Stimulation
Measured: 1-7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionJun 2009 (estimated)
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- Casas Miguel, Prof., Principal investigator, Hospital Universitari Vall d'Hebron Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00209807
- Sponsor's protocol ID
- PFD-ESC
- Status last verified
- May 2010
- First submitted
- 13 Sep 2005
- Last updated
- 27 May 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Escitalopram vs. Reboxetine on Somatic and Visceral Sensitivity of Patients With Major Depressive Disorder: a Randomized, Double Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT00209807
- Acronym / sponsor ID
- PFD-ESC
- Conditions
- Major Depression, Pain, Abdominal Pain
- Keywords
- major depression, pain, escitalopram, reboxetine, visceral sensitivity, somatic sensitivity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: escitalopramsubjects with MDD randomized to Escitalopram |
| 2 | Active comparator | Drug: ReboxetineMDD patients receiving reboxetine |
| 3 | Other | Other: No interventionHealthy volonteers |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- MDD according with DSM-IV-TR
- Hamilton depression scale > 21
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| escitalopramAlso: reboxetineescitalopram 10 mg/d for 6 weeks | Drug | 1 |
| ReboxetineReboxetine 8 mg/d for 6 weeks | Drug | 2 |
| No interventionThis group of healthy volonteers will receive no drug and will be a healthy comparator. | Other | 3 |
Primary outcome
rectal distension Transcutaneous Electrical Neuro-Stimulation
Time frame: 1-7 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Casas Miguel, Prof. principal investigator
Hospital Universitari Vall d'Hebron Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing escitalopram and Reboxetine in people with Major Depression and Pain, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rectal distension Transcutaneous Electrical Neuro-Stimulation (time frame: 1-7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2010.