Depressive Disorder, Major
Conditions
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.
Interventions
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| The secondary endpoint is the difference in study participation burden between standard and enhanced data collection. | — |
Countries
United States
Outcome results
None listed