Study for Evaluating Different Methods of Measuring Depression Treatment Response

Pfizer165 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

165

Conditions

Depressive Disorder, Major

Interventions

electronic diaryPROCEDURE

SertralineDRUG

PlaceboDRUG

voice acousticsPROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (12)

Pfizer Investigational Site

Norwich, Connecticut, United States

Pfizer Investigational Site

Aventura, Florida, United States

Pfizer Investigational Site

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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