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
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01221935
First received: October 13, 2010
Last updated: January 25, 2011
Last verified: January 2011
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depressive Disorder |
Other: Pristiq first-line treatment charts Other: Pristiq second-line treatment charts Other: SNRI or SSRI first-line treatment charts Other: SNRI or SSRI second-line treatment charts |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Time Perspective: Retrospective |
| 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 300 charts including patients initiated on Pristiq within the past 6 months as a first-line treatment. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Incidence of adverse events and Incidence of discontinuation due to adverse events [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Percent of patients experiencing relapse [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Length of time to relapse [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Percent of discontinuation / medication switches due to lack of efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Subjective physician assessment of symptom control [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 2701 |
| Study Start Date: | September 2009 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Patients initiated on Pristiq as a first line treatment |
Other: Pristiq first-line treatment charts
300 charts including patients initiated on Pristiq within the past 6 months as a first-line treatment
|
| Patients initiated on Pristiq as a 2nd-line treatment |
Other: Pristiq second-line treatment charts
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)).
|
| Patients initiated on a SNRI or SSRI as a first-line treatment |
Other: SNRI or SSRI first-line treatment charts
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.
|
| Patients initiated on a SNRI or SSRI as a 2nd-line treatment |
Other: SNRI or SSRI second-line treatment charts
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).
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
patient charts from psychiatrists and primary care physicians (PCPs) treating patients suffering from major depressive disorder (MDD).
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients who have not been treated for depression.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT01221935 History of Changes |
| Other Study ID Numbers: | 3151A1-4431, B2061039 |
| Study First Received: | October 13, 2010 |
| Last Updated: | January 25, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
retrospective chart review study desvenlafaxine utilization psychiatrists and primary care physicians treatment of major depressive disorder |
Additional relevant MeSH terms:
|
Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms Serotonin Uptake Inhibitors O-desmethylvenlafaxine Neurotransmitter Uptake Inhibitors |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013