Study for Evaluating Different Methods of Measuring Depression Treatment Response

August 20, 2008 updated by: Pfizer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

165

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Pfizer Investigational Site
    • Florida
      • Aventura, Florida, United States, 33180
        • Pfizer Investigational Site
      • Jacksonville, Florida, United States, 32216
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33143
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33125
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33134
        • Pfizer Investigational Site
      • Orlando, Florida, United States, 32806
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Pfizer Investigational Site
    • New York
      • Elmsford, New York, United States, 10523
        • Pfizer Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Pfizer Investigational Site
    • Texas
      • Plano, Texas, United States, 75024
        • Pfizer Investigational Site
    • Utah
      • Midvale, Utah, United States, 84047
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

November 30, 2006

First Submitted That Met QC Criteria

November 30, 2006

First Posted (Estimate)

December 4, 2006

Study Record Updates

Last Update Posted (Estimate)

August 21, 2008

Last Update Submitted That Met QC Criteria

August 20, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A9001337

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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