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NCT00406952 Clinical Trial

Study for Evaluating Different Methods of Measuring Depression Treatment Response

Depressive Disorder, Major Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00406952
Other study ID # A9001337
Secondary ID
Status Completed
Phase N/A
First received November 30, 2006
Last updated August 20, 2008
Start date November 2006
Est. completion date August 2007

Study information
Verified date August 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 165
Est. completion date August 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• electronic diary

Drug:
• Sertraline

• Placebo

Procedure:
• voice acoustics

Locations
Country Name City State
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Aventura Florida
United States Pfizer Investigational Site Elmsford New York
United States Pfizer Investigational Site Jacksonville Florida
United States Pfizer Investigational Site Memphis Tennessee
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Midvale Utah
United States Pfizer Investigational Site Norwich Connecticut
United States Pfizer Investigational Site Orlando Florida
United States Pfizer Investigational Site Plano Texas

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 The secondary endpoint is the difference in study participation burden between standard and enhanced data collection.
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