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| Sponsor: | National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT01082237 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depressive Disorder |
Drug: Escitalopram |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Biomarkers for Outcomes In Late-life Depression |
| Estimated Enrollment: | 80 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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
|
Eligibility| Ages Eligible for Study: | 62 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jennifer Villalobos | 310-825-0248 | jpv@brain.ucla.edu |
| Contact: Kelly Nielson | 310-206-8983 | knielson@brain.ucla.edu |
| United States, California | |
| UCLA Semel Institute | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: Jennifer Villalobos 310-825-0248 jpv@brain.ucla.edu | |
| Contact: Kelly Nielson 310-206-8983 knielson@brain.ucla.edu | |
| Principal Investigator: Ian A Cook, MD | |
| Principal Investigator: | Ian A Cook, MD | University of California, Los Angeles |
More Information
| Responsible Party: | Ian A. Cook, MD, Semel Institutue, University of California Los Angeles |
| ClinicalTrials.gov Identifier: | NCT01082237 History of Changes |
| Other Study ID Numbers: | 1RC1MH088438 |
| Study First Received: | March 5, 2010 |
| Last Updated: | October 15, 2010 |
| Health Authority: | United States: Federal Government |
|
Major Depressive Disorder EEG SSRI |
|
Depression Depressive Disorder Depressive Disorder, Major Behavioral Symptoms Mood Disorders Mental Disorders Dexetimide Citalopram Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Parasympatholytics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Serotonin Agents |