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Trial record 1 of 1 for:    NCT00406952
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Study for Evaluating Different Methods of Measuring Depression Treatment Response

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00406952
Recruitment Status : Completed
First Posted : December 4, 2006
Last Update Posted : August 21, 2008
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Procedure: electronic diary Drug: Sertraline Drug: Placebo Procedure: voice acoustics Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2006
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  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 Outcome Measures :
  1. The secondary endpoint is the difference in study participation burden between standard and enhanced data collection.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00406952

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United States, Connecticut
Pfizer Investigational Site
Norwich, Connecticut, United States, 06360
United States, Florida
Pfizer Investigational Site
Aventura, Florida, United States, 33180
Pfizer Investigational Site
Jacksonville, Florida, United States, 32216
Pfizer Investigational Site
Miami, Florida, United States, 33125
Pfizer Investigational Site
Miami, Florida, United States, 33134
Pfizer Investigational Site
Miami, Florida, United States, 33143
Pfizer Investigational Site
Orlando, Florida, United States, 32806
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30328
United States, New York
Pfizer Investigational Site
Elmsford, New York, United States, 10523
United States, Tennessee
Pfizer Investigational Site
Memphis, Tennessee, United States, 38119
United States, Texas
Pfizer Investigational Site
Plano, Texas, United States, 75024
United States, Utah
Pfizer Investigational Site
Midvale, Utah, United States, 84047
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00406952    
Other Study ID Numbers: A9001337
First Posted: December 4, 2006    Key Record Dates
Last Update Posted: August 21, 2008
Last Verified: August 2008
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs