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OpenTrials
Completed

NCT Number: NCT00406952

Study for Evaluating Different Methods of Measuring Depression Treatment Response

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.

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Key information

Conditions

Depressive Disorder, Major Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pfizer Investigational Site, Norwich, Connecticut, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

electronic diary

Procedure

Sertraline

Drug

Placebo

Drug

voice acoustics

Procedure

Primary outcomes

  1. 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 outcomes

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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2006
Study completion
2007
First posted
Dec 4, 2006
Registry last updated
Aug 21, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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