Depressive SymptomsPhase 2/3NCT00136383
Comparing Paroxetine and Duloxetine on Cardiovascular Measures
A Phase 2/3 study testing paroxetine versus duloxetine in people with Depressive Symptoms, run by Duke University at 1 site in United States.
Trial summary
This double-blind placebo-controlled trial is designed to test and to compare the cardiovascular profile of paroxetine controlled release (CR) with duloxetine in outpatients with depressive symptoms. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- paroxetine versus duloxetine
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Jun 2007
- Phase
- Phase 2/3
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Depressive symptoms
- Ages 20-60
- In good medical health and not pregnant
Who cannot join
- Bipolar disorder
- Schizophrenia or other psychotic disorder
- Alcohol or other substance abuse within the last 3 months
- Cognitive impairment
- History of attempted suicide in the past 2 months and who score 4 or more on the suicide item of the MADRS
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Official title: A Study of the Effects of Paroxetine vs. Duloxetine on Heart Rate Variability and Autonomic Cardiovascular Control
This double-blind placebo-controlled trial is designed to test and to compare the cardiovascular profile of paroxetine controlled release (CR) with duloxetine in outpatients with depressive symptoms.
Read the detailed description
This double-blind placebo-controlled study will test the hypothesis that greater reduction in heart rate variability will be associated with duloxetine than paroxetine in outpatients with major depressive disorder. We will also examine the relationship between changes in heart rate variability to the magnitude of serotonin and norepinephrine transporter occupancy produced by each drug.
- Conditions
- Depressive Symptoms
- Being tested
- paroxetine versus duloxetine
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paroxetine versus duloxetineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
R-R interval change with deep breathing
Respiratory sinus arrhythmia
Secondary outcomes (6)
Montgomery-Asberg Depression Rating Scale (MADRS)
Hospital Anxiety and Depression Scale
Spielberger State-Trait Anxiety Inventory
Connor-Davidson Resilience Scale
Norepinephrine receptor occupancy
Serotonin receptor occupancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study startMar 2005
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Wei Zhang, M.D., Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00136383
- Sponsor's protocol ID
- Pro00007207
- Other IDs
- 6956-05-3R0
- Status last verified
- Sep 2007
- First submitted
- 25 Aug 2005
- Last updated
- 21 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Effects of Paroxetine vs. Duloxetine on Heart Rate Variability and Autonomic Cardiovascular Control
- ClinicalTrials.gov ID
- NCT00136383
- Acronym / sponsor ID
- Pro00007207
- Conditions
- Depressive Symptoms
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Mar 2005
- Study completion
- Jun 2007 (actual)
- First posted
- 29 Aug 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.
This double-blind placebo-controlled trial is designed to test and to compare the cardiovascular profile of paroxetine controlled release (CR) with duloxetine in outpatients with depressive symptoms.
Detailed description
This double-blind placebo-controlled study will test the hypothesis that greater reduction in heart rate variability will be associated with duloxetine than paroxetine in outpatients with major depressive disorder. We will also examine the relationship between changes in heart rate variability to the magnitude of serotonin and norepinephrine transporter occupancy produced by each drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Depressive symptoms
- Ages 20-60
- In good medical health and not pregnant
Key exclusion criteria (5 listed)
- Bipolar disorder
- Schizophrenia or other psychotic disorder
- Alcohol or other substance abuse within the last 3 months
- Cognitive impairment
- History of attempted suicide in the past 2 months and who score 4 or more on the suicide item of the MADRS
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 |
|---|---|---|
| paroxetine versus duloxetine | Drug | – |
Primary outcome
R-R interval change with deep breathing
Respiratory sinus arrhythmia
6 secondary outcomes
Montgomery-Asberg Depression Rating Scale (MADRS)
Hospital Anxiety and Depression Scale
Spielberger State-Trait Anxiety Inventory
Connor-Davidson Resilience Scale
Norepinephrine receptor occupancy
Serotonin receptor occupancy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2014.
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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.
Wei Zhang, M.D., Ph.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing paroxetine versus duloxetine in people with Depressive Symptoms, run by Duke University at 1 site in United States.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 21 Jul 2014. 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 United States. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R-R interval change with deep breathing. The study lists 2 primary outcomes in all. 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 21 Jul 2014.