Major Depressive DisorderNCT01221935
Retrospective Study Evaluating The Current Utilization Of Desvenlafaxine Succinate Sustained-Release (Pristiq) Among Psychiatrists And Primary Care Physicians In The Treatment Of Patients With Major Depressive Disorder
An observational study of Major Depressive Disorder, run by Pfizer.
Trial summary
The goal of this observational study is to learn about how Pristiq is currently being used in general practice and how psychiatrists and primary care physicians currently perceive Pristiq in terms of efficacy, tolerability, and adherence compared to other treatments for major depressive disorder (MDD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Pristiq first-line treatment charts, Pristiq second-line treatment charts and SNRI or SSRI first-line treatment charts
- How many people
- 2,701 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Jan 2010
- Phase
- Observational
- 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
Study population: patient charts from psychiatrists and primary care physicians (PCPs) treating patients suffering from major depressive disorder (MDD).
Who may be able to join
- Patients must be adult, diagnosed with major depressive disorder and treated with pharmacotherapy.
- Physicians must be either a psychiatrist or a primary care physician, a prescriber of Pristiq, have at least 3 charts representing the 4 identified patient types, have been in clinical practice between 4 and 35 years, primarily office based (50%+), not participated in a research study relating to antidepressants or antidepressant therapy within the past month, not a consultant or have a professional relationship with a pharmaceutical company other than for clinical trials or speaking engagements, and not be employed by of affiliated with an advertising agency, market research company, or pharmaceutical company.
Who cannot join
- Patients who have not been treated for depression.
About this study
Official title: A Retrospective Study To Evaluate The Current Utilization Of Desvenlafaxine Among Psychiatrists And Primary Care Physicians In The Treatment Of Patients With Major Depressive Disorder
The goal of this observational study is to learn about how Pristiq is currently being used in general practice and how psychiatrists and primary care physicians currently perceive Pristiq in terms of efficacy, tolerability, and adherence compared to other treatments for major depressive disorder (MDD).
Read the detailed description
It is retrospective patient chart study among psychiatrists and primary care physicians (PCPs) treating patients suffering from major depressive disorder (MDD). Physicians will be asked general medical questions in order to quantify their prescribing behavior and their perception of treatment performance. A retrospective patient chart review will then be performed and patient data will be collected to document patient characteristics and actual treatment outcomes. Upon qualification, specific instructions for chart review will be provided. Once the identified charts are pulled, the physicians are instructed to continue with the on-line survey. In total, there will be approximately 450 psychiatrists and 450 primary care physicians participating in this trial.
- Conditions
- Major Depressive Disorder
- Being tested
- Pristiq first-line treatment charts, Pristiq second-line treatment charts, SNRI or SSRI first-line treatment charts, SNRI or SSRI second-line treatment charts
- Keywords
- retrospective chart review study, desvenlafaxine utilization, psychiatrists and primary care physicians, treatment of major depressive disorder
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pristiq first-line treatment chartsOther
300 charts including patients initiated on Pristiq within the past 6 months as a first-line treatment
Pristiq second-line treatment chartsOther
800 charts including patients initiated on Pristiq within the past 6 months as a second-line treatment (following first-line treatment with a Serotonin Norepinephrine Reuptake Inhibitor (SNRI) or Selective Serotonin Reuptake Inhibitors (SSRIs)).
SNRI or SSRI first-line treatment chartsOther
800 charts including patients initiated on a Serotonin Norepinephrine Reuptake Inhibitor (SNRI) or Selective Serotonin Reuptake Inhibitors (SSRIs) (excluding Pristiq) within the past 6 months as a first-line treatment.
SNRI or SSRI second-line treatment chartsOther
800 charts including patients initiated on a Serotonin Norepinephrine Reuptake Inhibitor (SNRI) or Selective Serotonin Reuptake Inhibitors (SSRIs)(excluding Pristiq) within the past 6 months as a second-line treatment (following the first-line treatment with a SNRI or SSRI).
| Study group | Role | What they receive |
|---|---|---|
| Patients initiated on Pristiq as a first line treatment | Not described Receives: Other: Pristiq first-line treatment charts | |
| Patients initiated on Pristiq as a 2nd-line treatment | Not described Receives: Other: Pristiq second-line treatment charts | |
| Patients initiated on a SNRI or SSRI as a first-line treatment | Not described Receives: Other: SNRI or SSRI first-line treatment charts | |
| Patients initiated on a SNRI or SSRI as a 2nd-line treatment | Not described Receives: Other: SNRI or SSRI second-line treatment charts |
What is being measured
The primary outcome is the main question the study is designed to answer.
300 charts including patients initiated on Pristiq within the past 6 months as a first-line treatment.
Measured: 6 months
800 charts including patients initiated on Pristiq within the past 6 months as a second-line treatment (following first-line treatment with a SNRI or SSRI).
Measured: 6 months
800 charts including patients initiated on a SNRI or SSRI (excluding Pristiq) within the past 6 months as a first-line treatment.
Measured: 6 months
800 charts including patients initiated on a SNRI or SSRI (excluding Pristiq) within the past 6 months as a second-line treatment (following the first-line treatment with a SNRI or SSRI).
Measured: 6 months
Secondary outcomes (5)
Incidence of adverse events and Incidence of discontinuation due to adverse events
Measured: 6 months
Percent of patients experiencing relapse
Measured: 6 months
Length of time to relapse
Measured: 6 months
Percent of discontinuation / medication switches due to lack of efficacy
Measured: 6 months
Subjective physician assessment of symptom control
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startSep 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 2,701 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01221935
- Sponsor's protocol ID
- 3151A1-4431
- Other IDs
- B2061039
- Status last verified
- Jan 2011
- First submitted
- 13 Oct 2010
- Last updated
- 26 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study To Evaluate The Current Utilization Of Desvenlafaxine Among Psychiatrists And Primary Care Physicians In The Treatment Of Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT01221935
- Acronym / sponsor ID
- 3151A1-4431
- Conditions
- Major Depressive Disorder
- Keywords
- retrospective chart review study, desvenlafaxine utilization, psychiatrists and primary care physicians, treatment of major depressive disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,701 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 18 Oct 2010 (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 goal of this observational study is to learn about how Pristiq is currently being used in general practice and how psychiatrists and primary care physicians currently perceive Pristiq in terms of efficacy, tolerability, and adherence compared to other treatments for major depressive disorder (MDD).
Detailed description
It is retrospective patient chart study among psychiatrists and primary care physicians (PCPs) treating patients suffering from major depressive disorder (MDD). Physicians will be asked general medical questions in order to quantify their prescribing behavior and their perception of treatment performance. A retrospective patient chart review will then be performed and patient data will be collected to document patient characteristics and actual treatment outcomes. Upon qualification, specific instructions for chart review will be provided. Once the identified charts are pulled, the physicians are instructed to continue with the on-line survey. In total, there will be approximately 450 psychiatrists and 450 primary care physicians participating in this trial.
Study design
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients initiated on Pristiq as a first line treatment | – | Other: Pristiq first-line treatment charts |
| Patients initiated on Pristiq as a 2nd-line treatment | – | Other: Pristiq second-line treatment charts |
| Patients initiated on a SNRI or SSRI as a first-line treatment | – | Other: SNRI or SSRI first-line treatment charts |
| Patients initiated on a SNRI or SSRI as a 2nd-line treatment | – | Other: SNRI or SSRI second-line treatment charts |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient charts from psychiatrists and primary care physicians (PCPs) treating patients suffering from major depressive disorder (MDD).
Key inclusion criteria (2 listed)
- Patients must be adult, diagnosed with major depressive disorder and treated with pharmacotherapy.
- Physicians must be either a psychiatrist or a primary care physician, a prescriber of Pristiq, have at least 3 charts representing the 4 identified patient types, have been in clinical practice between 4 and 35 years, primarily office based (50%+), not participated in a research study relating to antidepressants or antidepressant therapy within the past month, not a consultant or have a professional relationship with a pharmaceutical company other than for clinical trials or speaking engagements, and not be employed by of affiliated with an advertising agency, market research company, or pharmaceutical company.
Key exclusion criteria (1 listed)
- Patients who have not been treated for depression.
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 |
|---|---|---|
| Pristiq first-line treatment charts300 charts including patients initiated on Pristiq within the past 6 months as a first-line treatment | Other | Patients initiated on Pristiq as a first line treatment |
| Pristiq second-line treatment charts800 charts including patients initiated on Pristiq within the past 6 months as a second-line treatment (following first-line treatment with a Serotonin Norepinephrine Reuptake Inhibitor (SNRI) or Selective Serotonin Reuptake Inhibitors (SSRIs)). | Other | Patients initiated on Pristiq as a 2nd-line treatment |
| SNRI or SSRI first-line treatment charts800 charts including patients initiated on a Serotonin Norepinephrine Reuptake Inhibitor (SNRI) or Selective Serotonin Reuptake Inhibitors (SSRIs) (excluding Pristiq) within the past 6 months as a first-line treatment. | Other | Patients initiated on a SNRI or SSRI as a first-line treatment |
| SNRI or SSRI second-line treatment charts800 charts including patients initiated on a Serotonin Norepinephrine Reuptake Inhibitor (SNRI) or Selective Serotonin Reuptake Inhibitors (SSRIs)(excluding Pristiq) within the past 6 months as a second-line treatment (following the first-line treatment with a SNRI or SSRI). | Other | Patients initiated on a SNRI or SSRI as a 2nd-line treatment |
Primary outcome
300 charts including patients initiated on Pristiq within the past 6 months as a first-line treatment.
Time frame: 6 months
800 charts including patients initiated on Pristiq within the past 6 months as a second-line treatment (following first-line treatment with a SNRI or SSRI).
Time frame: 6 months
800 charts including patients initiated on a SNRI or SSRI (excluding Pristiq) within the past 6 months as a first-line treatment.
Time frame: 6 months
800 charts including patients initiated on a SNRI or SSRI (excluding Pristiq) within the past 6 months as a second-line treatment (following the first-line treatment with a SNRI or SSRI).
Time frame: 6 months
5 secondary outcomes
Incidence of adverse events and Incidence of discontinuation due to adverse events
Time frame: 6 months
Percent of patients experiencing relapse
Time frame: 6 months
Length of time to relapse
Time frame: 6 months
Percent of discontinuation / medication switches due to lack of efficacy
Time frame: 6 months
Subjective physician assessment of symptom control
Time frame: 6 months
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 26 Jan 2011.
- 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
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, run by Pfizer.
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 1 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 26 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
300 charts including patients initiated on Pristiq within the past 6 months as a first-line treatment. (time frame: 6 months). The study lists 4 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 26 Jan 2011.