Study for Evaluating Different Methods of Measuring Depression Treatment Response
A Phase 4 Randomized, Double-Blind, Placebo Controlled Methodology Study to Evaluate the Time of Onset of AntiDepressant Response in Subjects With Major Depressive Disorder
1 other identifier
interventional
165
1 country
12
Brief Summary
Purpose of the study is to evaluate use of electronic diaries and voice acoustics for use in future depression clinical trial. Focus is on increased precision of measurement.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2006
Shorter than P25 for not_applicable
12 active sites
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
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 30, 2006
CompletedFirst Posted
Study publicly available on registry
December 4, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedAugust 21, 2008
August 1, 2008
November 30, 2006
August 20, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
The primary endpoint is time to treatment response and difference in time to response for the two data collection methods - daily patient electronic assessment versus weekly assessments measured in clinic.
Secondary Outcomes (1)
The secondary endpoint is the difference in study participation burden between standard and enhanced data collection.
Interventions
Eligibility Criteria
You may qualify if:
- Primary diagnosis of Major Depressive Disorder with symptoms of depression present at least 1 month
- Psychotropic medications currently not being taken
You may not qualify if:
- Failure to respond in past 5 years to antidepressant therapy of adequate duration and dosing
- Diagnoses of following conditions or disorders within past 6 months: generalized anxiety, obsessive compulsive, panic, post stress, anorexia, bulimia, alcohol or substance abuse or social anxiety disorder
- Diagnoses current or past of the following conditions or disorders: schizophrenia, psychotic disorder, delieium, dememtia, amnestic cognitive disorder, bipolar
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (12)
Pfizer Investigational Site
Norwich, Connecticut, 06360, United States
Pfizer Investigational Site
Aventura, Florida, 33180, United States
Pfizer Investigational Site
Jacksonville, Florida, 32216, United States
Pfizer Investigational Site
Miami, Florida, 33125, United States
Pfizer Investigational Site
Miami, Florida, 33134, United States
Pfizer Investigational Site
Miami, Florida, 33143, United States
Pfizer Investigational Site
Orlando, Florida, 32806, United States
Pfizer Investigational Site
Atlanta, Georgia, 30328, United States
Pfizer Investigational Site
Elmsford, New York, 10523, United States
Pfizer Investigational Site
Memphis, Tennessee, 38119, United States
Pfizer Investigational Site
Plano, Texas, 75024, United States
Pfizer Investigational Site
Midvale, Utah, 84047, United States
Related Publications (1)
Mundt JC, Vogel AP, Feltner DE, Lenderking WR. Vocal acoustic biomarkers of depression severity and treatment response. Biol Psychiatry. 2012 Oct 1;72(7):580-7. doi: 10.1016/j.biopsych.2012.03.015. Epub 2012 Apr 26.
PMID: 22541039DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 30, 2006
First Posted
December 4, 2006
Study Start
November 1, 2006
Study Completion
August 1, 2007
Last Updated
August 21, 2008
Record last verified: 2008-08