Evaluation of Depression Symptoms and Brain Activity Associated With Response to Treatment of Depression
NCT00200902
ABOUT THIS STUDY
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- Clinical diagnosis of unipolar major depression
- Substance abuse
- Psychotic disorder
- History of severe head trauma
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Descriptive Information | ||||
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Brief Title ICMJE | Evaluation of Depression Symptoms and Brain Activity Associated With Response to Treatment of Depression | |||
Official Title ICMJE | Factors of Treatment Response in Major Depressive Disorder | |||
Brief Summary | This study will use measurements of depression symptoms and brain activity to determine what factors may influence an individual's response to treatment for depression. | |||
Detailed Description | We are using depression symptom measurements and measurements of brain electrical activity (EEG) to determine what factors may influence whether a patient is likely to show a response to antidepressant medication, placebo, or only clinical visits (without the use of pills) during a treatment trial for depression. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Depression | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Leuchter AF, Hunter AM, Tartter M, Cook IA. Role of pill-taking, expectation and therapeutic alliance in the placebo response in clinical trials for major depression. Br J Psychiatry. 2014 Dec;205(6):443-9. doi: 10.1192/bjp.bp.113.140343. Epub 2014 Sep 11. | |||
* 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 | 88 | |||
Original Enrollment ICMJE | 120 | |||
Actual Study Completion Date ICMJE | June 2009 | |||
Actual Primary Completion Date | June 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 | NCT00200902 | |||
Other Study ID Numbers ICMJE | R01AT002479-02( U.S. NIH Grant/Contract ) R01AT002479-02 ( U.S. NIH Grant/Contract ) 04-02-068 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Andrew F. Leuchter, University of California, Los Angeles | |||
Study Sponsor ICMJE | University of California, Los Angeles | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University of California, Los Angeles | |||
Verification Date | March 2019 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |