NCT01221935

Brief 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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,701

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2009

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 18, 2010

Completed
Last Updated

January 26, 2011

Status Verified

January 1, 2011

Enrollment Period

4 months

First QC Date

October 13, 2010

Last Update Submit

January 25, 2011

Conditions

Keywords

retrospective chart review studydesvenlafaxine utilizationpsychiatrists and primary care physicianstreatment of major depressive disorder

Outcome Measures

Primary Outcomes (4)

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

    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).

    6 months

  • 800 charts including patients initiated on a SNRI or SSRI (excluding Pristiq) within the past 6 months as a first-line treatment.

    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).

    6 months

Secondary Outcomes (5)

  • Incidence of adverse events and Incidence of discontinuation due to adverse events

    6 months

  • Percent of patients experiencing relapse

    6 months

  • Length of time to relapse

    6 months

  • Percent of discontinuation / medication switches due to lack of efficacy

    6 months

  • Subjective physician assessment of symptom control

    6 months

Study Arms (4)

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

Interventions

300 charts including patients initiated on Pristiq within the past 6 months as a first-line treatment

Patients initiated on Pristiq as a first line treatment

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 Pristiq as a 2nd-line treatment

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 first-line treatment

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).

Patients initiated on a SNRI or SSRI as a 2nd-line treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patient charts from psychiatrists and primary care physicians (PCPs) treating patients suffering from major depressive disorder (MDD).

You may qualify if:

  • 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.

You may not qualify if:

  • Patients who have not been treated for depression.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Serotonin and Noradrenaline Reuptake Inhibitors

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake InhibitorsMembrane Transport ModulatorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesNeurotransmitter AgentsPhysiological Effects of Drugs

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 13, 2010

First Posted

October 18, 2010

Study Start

September 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

January 26, 2011

Record last verified: 2011-01