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Study for Evaluating Different Methods of Measuring Depression Treatment Response

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00406952
First received: November 30, 2006
Last updated: August 20, 2008
Last verified: August 2008

November 30, 2006
August 20, 2008
November 2006
Not Provided
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.
Same as current
Complete list of historical versions of study NCT00406952 on ClinicalTrials.gov Archive Site
The secondary endpoint is the difference in study participation burden between standard and enhanced data collection.
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Depressive Disorder, Major
  • Procedure: electronic diary
  • Drug: Sertraline
  • Drug: Placebo
  • Procedure: voice acoustics
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
165
August 2007
Not Provided

Inclusion Criteria:

  • Primary diagnosis of Major Depressive Disorder with symptoms of depression present at least 1 month
  • Psychotropic medications currently not being taken

Exclusion Criteria:

  • 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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00406952
A9001337
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP