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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01221935
• Other study ID #: 3151A1-4431
• Secondary ID: B2061039
• Status: Completed
• Phase: Phase 4
• First received: October 13, 2010
• Last updated: January 25, 2011
• Start date: September 2009
• Est. completion date: January 2010

Study information

• Verified date: January 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2701
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Other:
• Pristiq first-line treatment charts
300 charts including patients initiated on Pristiq within the past 6 months as a first-line treatment
• 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)).
• 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.
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	300 charts including patients initiated on Pristiq within the past 6 months as a first-line treatment.		6 months	No
Primary	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).		6 months	No
Primary	800 charts including patients initiated on a SNRI or SSRI (excluding Pristiq) within the past 6 months as a first-line treatment.		6 months	No
Primary	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).		6 months	No
Secondary	Incidence of adverse events and Incidence of discontinuation due to adverse events		6 months	No
Secondary	Percent of patients experiencing relapse		6 months	No
Secondary	Length of time to relapse		6 months	No
Secondary	Percent of discontinuation / medication switches due to lack of efficacy		6 months	No
Secondary	Subjective physician assessment of symptom control		6 months	No

External Links

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