Study for Evaluating Different Methods of Measuring Depression Treatment Response
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00406952
First received: November 30, 2006
Last updated: August 20, 2008
Last verified: August 2008
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Depressive Disorder, Major |
Procedure: electronic diary Drug: Sertraline Drug: Placebo Procedure: voice acoustics |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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:
- The secondary endpoint is the difference in study participation burden between standard and enhanced data collection.
| Enrollment: | 165 |
| Study Start Date: | November 2006 |
| Study Completion Date: | August 2007 |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00406952
Locations
| United States, Connecticut | |
| Pfizer Investigational Site | |
| Norwich, Connecticut, United States, 06360 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Aventura, Florida, United States, 33180 | |
| Pfizer Investigational Site | |
| Jacksonville, Florida, United States, 32216 | |
| Pfizer Investigational Site | |
| Miami, Florida, United States, 33125 | |
| Pfizer Investigational Site | |
| Miami, Florida, United States, 33143 | |
| Pfizer Investigational Site | |
| Miami, Florida, United States, 33134 | |
| Pfizer Investigational Site | |
| Orlando, Florida, United States, 32806 | |
| United States, Georgia | |
| Pfizer Investigational Site | |
| Atlanta, Georgia, United States, 30328 | |
| United States, New York | |
| Pfizer Investigational Site | |
| Elmsford, New York, United States, 10523 | |
| United States, Tennessee | |
| Pfizer Investigational Site | |
| Memphis, Tennessee, United States, 38119 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Plano, Texas, United States, 75024 | |
| United States, Utah | |
| Pfizer Investigational Site | |
| Midvale, Utah, United States, 84047 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided by Pfizer
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00406952 History of Changes |
| Other Study ID Numbers: | A9001337 |
| Study First Received: | November 30, 2006 |
| Last Updated: | August 20, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms Sertraline Antidepressive Agents Psychotropic Drugs |
Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013