DepressionPhase 3NCT00329147
Study Evaluating the Effects of DVS SR and Paroxetine on the Pharmacokinetics of Desipramine in Healthy Subjects
A Phase 3 study testing desvenlafaxine SR, desipramine and paroxetine in people with Depression, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effects of multiple doses of DVS SR and paroxetine on the pharmacokinetics of a single dose of desipramine in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- desvenlafaxine SR, desipramine and paroxetine
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Jun 2006
- Phase
- Phase 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women between 18 to 55 years of age
- Healthy as determined by the investigator on the basis of medical history and physical examination, laboratory test results, vital signs, and 12-lead electrocardiogram (ECG)
- History of being a nonsmoker for at least 1 year Other inclusions apply.
Who cannot join
- Presence or history of any disorder or significant cardiovascular, hepatic, renal, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, or neurologic condition, and any severe conditions of the ears, eyes or throat (such as glaucoma or increased intraocular pressure) or psychiatric disease
- Known or suspected alcohol abuse or consumption of more than 2 standard units per day within the past 6 months
- Use of any over-the-counter, prescription, hormonal therapy or investigational medications within 30 days of study day-1 until the end of the study Other exclusions apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, Cross-Over Drug Interaction Study to Evaluate the Effects of Desvenlafaxine (DVS SR) and Paroxetine on the Pharmacokinetics of Desipramine in Healthy Subjects
The purpose of this study is to evaluate the effects of multiple doses of DVS SR and paroxetine on the pharmacokinetics of a single dose of desipramine in healthy subjects.
- Conditions
- Depression
- Being tested
- desvenlafaxine SR, desipramine, paroxetine
- Keywords
- Healthy Subjects, Major Depressive Disorder, Depression
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
desvenlafaxine SRDrug
desipramineDrug
paroxetineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of the study is to evaluate the effects of multiple doses of DVS SR and paroxetine on the pharmacokinetics of a single dose of desipramine in healthy subjects.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2006 (estimated)
- Study startMay 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00329147
- Sponsor's protocol ID
- 3151A1-900
- Status last verified
- Dec 2007
- First submitted
- 23 May 2006
- Last updated
- 7 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Cross-Over Drug Interaction Study to Evaluate the Effects of Desvenlafaxine (DVS SR) and Paroxetine on the Pharmacokinetics of Desipramine in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00329147
- Acronym / sponsor ID
- 3151A1-900
- Conditions
- Depression
- Keywords
- Healthy Subjects, Major Depressive Disorder, Depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Study completion
- Jun 2006 (actual)
- First posted
- 24 May 2006 (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.
The purpose of this study is to evaluate the effects of multiple doses of DVS SR and paroxetine on the pharmacokinetics of a single dose of desipramine in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy men and women between 18 to 55 years of age
- Healthy as determined by the investigator on the basis of medical history and physical examination, laboratory test results, vital signs, and 12-lead electrocardiogram (ECG)
- History of being a nonsmoker for at least 1 year Other inclusions apply.
Key exclusion criteria (3 listed)
- Presence or history of any disorder or significant cardiovascular, hepatic, renal, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, or neurologic condition, and any severe conditions of the ears, eyes or throat (such as glaucoma or increased intraocular pressure) or psychiatric disease
- Known or suspected alcohol abuse or consumption of more than 2 standard units per day within the past 6 months
- Use of any over-the-counter, prescription, hormonal therapy or investigational medications within 30 days of study day-1 until the end of the study Other exclusions apply.
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 |
|---|---|---|
| desvenlafaxine SR | Drug | – |
| desipramine | Drug | – |
| paroxetine | Drug | – |
Primary outcome
The primary outcome of the study is to evaluate the effects of multiple doses of DVS SR and paroxetine on the pharmacokinetics of a single dose of desipramine in healthy subjects.
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 7 Dec 2007.
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing desvenlafaxine SR, desipramine and paroxetine in people with Depression, run by Wyeth is now a wholly owned subsidiary of Pfizer 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 3 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 7 Dec 2007. 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 phase mean?
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?
The primary outcome of the study is to evaluate the effects of multiple doses of DVS SR and paroxetine on the pharmacokinetics of a single dose of desipramine in healthy subjects.. 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 7 Dec 2007.