Study for Evaluating Different Methods of Measuring Depression Treatment Response
NCT00406952
ABOUT THIS STUDY
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- Primary diagnosis of Major Depressive Disorder with symptoms of depression present at least 1 month
- Psychotropic medications currently not being taken
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Study for Evaluating Different Methods of Measuring Depression Treatment Response | |||
Official Title ICMJE | 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 | |||
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 Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
Condition ICMJE | Depressive Disorder, Major | |||
Intervention ICMJE |
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Study Arms ICMJE | Not Provided | |||
Publications * | Mundt JC, Vogel AP, Feltner DE, Lenderking WR. Vocal acoustic biomarkers of depression severity and treatment response. Biol Psychiatry. 2012 Oct 1;72(7):580-7. doi: 10.1016/j.biopsych.2012.03.015. Epub 2012 Apr 26. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 165 | |||
Original Enrollment ICMJE | 160 | |||
Actual Study Completion Date ICMJE | August 2007 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00406952 | |||
Other Study ID Numbers ICMJE | A9001337 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | August 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |