Biomarkers for Outcomes In Late-life Depression (BOLD) (BOLD)
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ClinicalTrials.gov Identifier: NCT01082237 |
Recruitment Status
:
Completed
First Posted
: March 8, 2010
Last Update Posted
: April 16, 2013
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Tracking Information | ||||
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First Submitted Date ICMJE | March 5, 2010 | |||
First Posted Date ICMJE | March 8, 2010 | |||
Last Update Posted Date | April 16, 2013 | |||
Study Start Date ICMJE | October 2009 | |||
Actual Primary Completion Date | October 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Score on Hamilton Depression Rating Scale (HAM-D) [ Time Frame: Measured nine times over 8 weeks ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01082237 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Score on Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) [ Time Frame: Measured nine times over 8 weeks ] | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Biomarkers for Outcomes In Late-life Depression (BOLD) | |||
Official Title ICMJE | Biomarkers for Outcomes In Late-life Depression | |||
Brief Summary | Major depressive disorder (MDD) is a common psychiatric illness with high cost to society and individual patients. One reason for the high cost is that most patients endure lengthy and ultimately unsuccessful empiric antidepressant trials before a successful medication is identified by trial-and-error. Care would be improved if a biomarker could determine, early in the course of treatment, whether a particular antidepressant would likely lead to response, remission, or treatment failure. Physicians could rapidly change treatments to an antidepressant which the biomarker indicated would be likely to help the patient. We have identified quantitative electroencephalographic (QEEG) changes that emerge early in the course of treatment with selective serotonin reuptake inhibitors (SSRIs) that appear to predict later response and remission in a general adult patient population. Demographic trends in the United States suggest that improved care for MDD will be essential for a growing number of elderly with late-life depression. While the consequences of prolonged trial-and-error periods to find a successful treatment are particularly inauspicious for elders with late-life depression, this patient group has not been included in the past studies which demonstrated the use of this biomarker approach in a general adult population. We propose a 12-week treatment trial to evaluate a practical biomarker for predicting outcome based on data from the first week of antidepressant treatment, with a focus only on depression in late life (age ≥65). There are three study Hypothesis: H1) ATR prediction of treatment outcome in older subjects will show >70% accuracy. H2) The predictive accuracy of the model will be enhanced by including clinical, socio-demographic, and genetic predictors. H3) The accuracy of ATR prediction will not show a significant dependence on subject gender. |
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 4 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Major Depressive Disorder | |||
Intervention ICMJE | Drug: Escitalopram
Start at 5mg per day, after four days increase to 10mg per day for the duration of the study. 20 mg will be administered at week 8 if not significantly better.
Other Name: Lexapro |
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Study Arms | Active Comparator: escitalopram
All subjects will receive escitalopram (ESC), brand name Lexapro (Forest Laboratories, Inc., New York) throughout the study. Dosing will start at 5 mg/d, be titrated to 10 mg after 4 days, and continue at 10 mg/d thereafter; an additional dose titration to 20 mg will be pursued at week 8 for those not significantly better (<50% improvement on IDS-30 at week 8 visit) and as tolerated.
Intervention: Drug: Escitalopram |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
80 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | October 2012 | |||
Actual Primary Completion Date | October 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 62 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | 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 | NCT01082237 | |||
Other Study ID Numbers ICMJE | 1RC1MH088438( U.S. NIH Grant/Contract ) 1RC1MH088438 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Ian A. Cook, M.D., National Institute of Mental Health (NIMH) | |||
Study Sponsor ICMJE | University of California, Los Angeles | |||
Collaborators ICMJE | National Institute of Mental Health (NIMH) | |||
Investigators ICMJE |
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PRS Account | University of California, Los Angeles | |||
Verification Date | April 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |