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
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


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
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, 33143
Pfizer Investigational Site
Miami, Florida, United States, 33134
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
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00406952     History of Changes
Other Study ID Numbers: A9001337
Study First Received: November 30, 2006
Last Updated: August 20, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Sertraline
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 21, 2014