Study for Evaluating Different Methods of Measuring Depression Treatment Response - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00406952

Purpose

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	Intervention
Depressive Disorder, Major	Procedure: electronic diary Drug: Sertraline Drug: Placebo Procedure: voice acoustics

MedlinePlus related topics: Depression

Drug Information available for: Sertraline hydrochloride Sertraline

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Pfizer:

Primary Outcome Measures:

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:

The secondary endpoint is the difference in study participation burden between standard and enhanced data collection.

Enrollment:	165
Study Start Date:	November 2006
Study Completion Date:	August 2007

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00406952

Locations

United States, Connecticut
Pfizer Investigational Site
Norwich, Connecticut, United States, 06360
United States, Florida
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
Jacksonville, Florida, United States, 32216
Pfizer Investigational Site
Orlando, Florida, United States, 32806
Pfizer Investigational Site
Aventura, Florida, United States, 33180
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

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

Study ID Numbers:	A9001337
Study First Received:	November 30, 2006
Last Updated:	August 20, 2008
ClinicalTrials.gov Identifier:	NCT00406952
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders
Sertraline

Depressive Disorder, Major
Depressive Disorder
Serotonin
Behavioral Symptoms

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors

Pharmacologic Actions
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009