Biomarkers for Outcomes In Late-life Depression (BOLD) (BOLD)

Tracking Information
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; (submitted: March 5, 2010)	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; (submitted: March 5, 2010)	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.
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
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
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
Publications *	Not Provided
* 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; (submitted: March 5, 2010)	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: 62 years of age or older; Meet the DSM-IV diagnosis of MDD based on Sheehan's Mini-International Neuropsychiatric Interview (MINI), with a score of > 28 on the 30-item Inventory of Depressive Symptomatology - Self Rated version (IDS-SR30) Exclusion Criteria: Subjects will have no unstable medical illness that would prevent completion of participation in the trial, determined as needed from physical examination, ECG, laboratory safety tests, as well as a review of systems; mentally or legally incapacitated, unable to give informed consent; meets DSM-IV criteria for anorexia nervosa, bulimia nervosa, obsessive-compulsive disorder, any cognitive disorder, bipolar disorder, psychotic disorder, or major depression with psychotic features; MMSE (Folstein et al., 1975) score ≤ 24; evidence of drug dependency or substance abuse within the preceding nine months; stable and in remission on current psychotropic medication(s); any ECT within the past six months; failure to tolerate ESC or treatment failure with an adequate trial of ESC in the current episode; ESC would be contraindicated (e.g., hyponatremia with a prior SSRI); treatment with fluoxetine or an MAOI within the past four weeks; any medical illness severe enough to significantly affect brain function or to interfere with interpretation of study results; history of seizures, brain surgery, skull fracture, significant head trauma, or abnormal EEG; psychiatric hospitalization indicated (e.g., imminent danger to self or others); initial QEEG recording is contaminated with artifact so that determination of the biomarker is precluded; use of medications known to affect brain function (e.g., antidepressants, anticonvulsants/mood stabilizers, anticholinergics, antipsychotics, benzodiazepines - same list as in BRITE-MD)
Sex/Gender	Sexes Eligible for Study: All
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 )
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	Principal Investigator: Ian A Cook, MD University of California, Los Angeles
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