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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Escitalopram
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depressive Disorder, EEG, SSRI

Eligibility Criteria

62 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • UCLA Semel Institute

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

escitalopram

Arm Description

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.

Outcomes

Primary Outcome Measures

Score on Hamilton Depression Rating Scale (HAM-D)

Secondary Outcome Measures

Score on Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30)

Full Information

First Posted
March 5, 2010
Last Updated
April 15, 2013
Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01082237
Brief Title
Biomarkers for Outcomes In Late-life Depression (BOLD)
Acronym
BOLD
Official Title
Biomarkers for Outcomes In Late-life Depression
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major Depressive Disorder, EEG, SSRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
escitalopram
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
Lexapro
Intervention Description
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.
Primary Outcome Measure Information:
Title
Score on Hamilton Depression Rating Scale (HAM-D)
Time Frame
Measured nine times over 8 weeks
Secondary Outcome Measure Information:
Title
Score on Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30)
Time Frame
Measured nine times over 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
62 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian A Cook, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Semel Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.nlm.nih.gov/medlineplus/depression.html
Description
Depression
URL
http://druginfo.nlm.nih.gov/drugportal/ProxyServlet
Description
Escitalopram

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Biomarkers for Outcomes In Late-life Depression (BOLD)

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