Study for Evaluating Different Methods of Measuring Depression Treatment Response

Not Applicable

Completed

• Conditions: Depressive Disorder, Major

• Registration Number: NCT00406952
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-11-30
• Study First Submitted QC: 2006-11-30
• Study First Posted: 2006-12-04
• Study Completion: 2007-08
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-20
• Last Update Posted: 2008-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Midvale, Utah, United States