Study for Evaluating Different Methods of Measuring Depression Treatment Response
NCT00406952
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Adult Trials: 18+ Years
- 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 | ||||
|---|---|---|---|---|
| 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 |
| |||
| 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:
| |||
| 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 |
| |||
| 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 | ||||