DepressionPhase 4NCT00788944
Determine The Percentage Of Depressed Outpatients Who Do Not Effectively Metabolize Extended-release Venlafaxine HCl
A Phase 4 study testing blood draw in people with Depression, run by Wyeth is now a wholly owned subsidiary of Pfizer at 52 sites in United States.
Trial summary
This is a study to determine the percentage of patients with depression who are treated with extended-release venlafaxine HCl (U.S. marketed brand Effexor XR®) who are Poor Metabolizers (based on the levels of the drug in the blood) at 2D6 (a system in the liver that breaks down some medications and other chemicals). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- blood draw
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 971 participants
- Where
- 52 sitesUnited States
- Study dates
- Oct 2008to Jul 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women subjects aged 18 years or older.
- Current outpatient treatment with extended-release venlafaxine HCl (U.S. marketed brand Effexor XR®), within the US Food and Drug Administration (FDA)-approved dosage range for depression (37.5 mg/day to 225 mg/day), for 8 weeks or less.
- Ability to have a blood draw within 4 to 12 hours of the most recent dose of Effexor XR®.
Who cannot join
- Determination by the investigator that a blood draw is contraindicated.
- Participation in an investigational study within the past 30 days where the study medication is not known.
- Previous treatment with Effexor XR® or extended-release venlafaxine HCl (generic) in the 6 months prior to current treatment regimen.
- Treatment with DVS SR within the last 30 days.
Trial locations and contacts
52 sites in 1 country.
52 sites in 1 country
United States52 sites
Pfizer Investigational Site
Albuquerque, New Mexico, 87108
Pfizer Investigational Site
Bellevue, Washington, 98004
Pfizer Investigational Site
Birmingham, Alabama, 35216
Pfizer Investigational Site
Bismarck, North Dakota, 58051
Pfizer Investigational Site
Bridgeville, Pennsylvania, 15017
Pfizer Investigational Site
Brooklyn, New York, 11223
Pfizer Investigational Site
Brooklyn, New York, 11235
Pfizer Investigational Site
Charlotte, North Carolina, 28209
Pfizer Investigational Site
Chesterfield, Missouri, 63017
Pfizer Investigational Site
Cincinnati, Ohio, 45245
Pfizer Investigational Site
Colorado Springs, Colorado, 80909
Pfizer Investigational Site
Columbia, Maryland, 21045
Pfizer Investigational Site
Coral Gables, Florida, 33134
Pfizer Investigational Site
Crestview Hills, Kentucky, 41017
Pfizer Investigational Site
Cromwell, Connecticut, 06416
Pfizer Investigational Site
Decatur, Georgia, 30033
Pfizer Investigational Site
Denver, Colorado, 80204
Pfizer Investigational Site
Fargo, North Dakota, 58104
Pfizer Investigational Site
Florence, Kentucky, 41042
Pfizer Investigational Site
Greenville, South Carolina, 29615
Pfizer Investigational Site
Jefferson City, Missouri, 65109
Pfizer Investigational Site
Kalamazoo, Michigan, 49009
Pfizer Investigational Site
Kalispell, Montana, 59901
Pfizer Investigational Site
Kettering, Ohio, 45429
Pfizer Investigational Site
Las Vegas, Nevada, 89119
Pfizer Investigational Site
Lauderhill, Florida, 33319
Pfizer Investigational Site
Little Rock, Arkansas, 72223
Pfizer Investigational Site
Mason, Ohio, 45040
Pfizer Investigational Site
Memphis, Tennessee, 38119
Pfizer Investigational Site
Milford, Connecticut, 06460
Pfizer Investigational Site
Mt. Pleasant, South Carolina, 29464
Pfizer Investigational Site
Naperville, Illinois, 60563
Pfizer Investigational Site
National City, California, 91950
Pfizer Investigational Site
Norman, Oklahoma, 73069
Pfizer Investigational Site
Oceanside, California, 92056
Pfizer Investigational Site
Oklahoma City, Oklahoma, 10213
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19139
Pfizer Investigational Site
Pittsfield, Massachusetts, 01201
Pfizer Investigational Site
Pottstown, Pennsylvania, 19464
Pfizer Investigational Site
Reading, Pennsylvania, 19606
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
Santa Ana, California, 92701
Pfizer Investigational Site
Staten Island, New York, 10312
Pfizer Investigational Site
Stevensville, Michigan, 49127
Pfizer Investigational Site
Temecula, California, 92591
Pfizer Investigational Site
Tuscon, Arizona, 85710
Pfizer Investigational Site
Watertown, Massachusetts, 02472
Pfizer Investigational Site
West Palm Beach, Florida, 33407
Pfizer Investigational Site
West Palm Beach, Florida, 33409
Pfizer Investigational Site
Wichita, Kansas, 67207
Pfizer Investigational Site
Wichita, Kansas, 67211
Pfizer Investigational Site
Wilmington, North Carolina, 28401
About this study
Official title: An Open-Label Study To Evaluate The Prevalence Of Phenotypic Poor Metabolizers At CYP2D6 Among Venlafaxine-Treated Outpatients With Depression
This is a study to determine the percentage of patients with depression who are treated with extended-release venlafaxine HCl (U.S. marketed brand Effexor XR®) who are Poor Metabolizers (based on the levels of the drug in the blood) at 2D6 (a system in the liver that breaks down some medications and other chemicals).
- Conditions
- Depression
- Being tested
- blood draw
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood drawProcedure or surgery
Test Article was not provided to subjects for this study.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Procedure: blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
0-desmethyl venlafaxine/venlafaxine ratio (levels of the drug in the blood)
Measured: 1 day
Secondary outcomes (1)
Determine the percentage of patients treated with extended-release venlafaxine HCl who are genotypic Poor Metabolizers.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 971 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00788944
- Sponsor's protocol ID
- 0600B1-4433
- Other IDs
- B2411001
- Status last verified
- Jan 2011
- First submitted
- 7 Nov 2008
- Last updated
- 7 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Preskorn SH, Kane CP, Lobello K, Nichols AI, Fayyad R, Buckley G, Focht K, Guico-Pabia CJ. Cytochrome P450 2D6 phenoconversion is common in patients being treated for depression: implications for personalized medicine. J Clin Psychiatry. 2013 Jun;74(6):614-21. doi: 10.4088/JCP.12m07807. Epub 2013 Mar 13.
PubMed 23541126
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study To Evaluate The Prevalence Of Phenotypic Poor Metabolizers At CYP2D6 Among Venlafaxine-Treated Outpatients With Depression
- ClinicalTrials.gov ID
- NCT00788944
- Acronym / sponsor ID
- 0600B1-4433
- Conditions
- Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 971 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 11 Nov 2008 (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 is a study to determine the percentage of patients with depression who are treated with extended-release venlafaxine HCl (U.S. marketed brand Effexor XR®) who are Poor Metabolizers (based on the levels of the drug in the blood) at 2D6 (a system in the liver that breaks down some medications and other chemicals).
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: blood draw |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women subjects aged 18 years or older.
- Current outpatient treatment with extended-release venlafaxine HCl (U.S. marketed brand Effexor XR®), within the US Food and Drug Administration (FDA)-approved dosage range for depression (37.5 mg/day to 225 mg/day), for 8 weeks or less.
- Ability to have a blood draw within 4 to 12 hours of the most recent dose of Effexor XR®.
Key exclusion criteria (4 listed)
- Determination by the investigator that a blood draw is contraindicated.
- Participation in an investigational study within the past 30 days where the study medication is not known.
- Previous treatment with Effexor XR® or extended-release venlafaxine HCl (generic) in the 6 months prior to current treatment regimen.
- Treatment with DVS SR within the last 30 days.
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 |
|---|---|---|
| blood drawTest Article was not provided to subjects for this study. | Procedure or surgery | 1 |
Primary outcome
0-desmethyl venlafaxine/venlafaxine ratio (levels of the drug in the blood)
Time frame: 1 day
1 secondary outcome
Determine the percentage of patients treated with extended-release venlafaxine HCl who are genotypic Poor Metabolizers.
Time frame: 1 day
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 Jan 2011.
- Derived from this study: PubMed 23541126Preskorn SH, Kane CP, Lobello K, Nichols AI, Fayyad R, Buckley G, Focht K, Guico-Pabia CJ. Cytochrome P450 2D6 phenoconversion is common in patients being treated for depression: implications for personalized medicine. J Clin Psychiatry. 2013 Jun;74(6):614-21. doi: 10.4088/JCP.12m07807. Epub 2013 Mar 13.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
52 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing blood draw in people with Depression, run by Wyeth is now a wholly owned subsidiary of Pfizer at 52 sites 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 4 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 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites 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 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?
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?
0-desmethyl venlafaxine/venlafaxine ratio (levels of the drug in the blood) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00788944, which also lists 1 linked publication.
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 Jan 2011.