- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01082237
Biomarkers for Outcomes In Late-life Depression (BOLD) (BOLD)
Biomarkers for Outcomes In Late-life Depression
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90095
- UCLA Semel Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Score on Hamilton Depression Rating Scale (HAM-D)
Time Frame: Measured nine times over 8 weeks
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Measured nine times over 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Score on Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30)
Time Frame: Measured nine times over 8 weeks
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Measured nine times over 8 weeks
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ian A Cook, MD, University of California, Los Angeles
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Antidepressive Agents, Second-Generation
- Citalopram
Other Study ID Numbers
- 1RC1MH088438 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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