Prospective testing of a neurophysiologic biomarker for treatment decisions in major depressive disorder: The PRISE-MD trial.

Autor: Cook IA; Department of Psychiatry and Biobehavioral Sciences, Semel Institute for Neuroscience and Human Behavior, David Geffen School of Medicine at UCLA, 760 Westwood Plaza, Los Angeles, CA, USA; Department of Bioengineering, Henry Samueli School of Engineering and Applied Science at UCLA, 410 Westwood Plaza, Los Angeles, CA, USA., Hunter AM; Department of Psychiatry and Biobehavioral Sciences, Semel Institute for Neuroscience and Human Behavior, David Geffen School of Medicine at UCLA, 760 Westwood Plaza, Los Angeles, CA, USA., Caudill MM; Department of Psychiatry and Biobehavioral Sciences, Semel Institute for Neuroscience and Human Behavior, David Geffen School of Medicine at UCLA, 760 Westwood Plaza, Los Angeles, CA, USA., Abrams MJ; Department of Psychiatry and Biobehavioral Sciences, Semel Institute for Neuroscience and Human Behavior, David Geffen School of Medicine at UCLA, 760 Westwood Plaza, Los Angeles, CA, USA., Leuchter AF; Department of Psychiatry and Biobehavioral Sciences, Semel Institute for Neuroscience and Human Behavior, David Geffen School of Medicine at UCLA, 760 Westwood Plaza, Los Angeles, CA, USA. Electronic address: afl@ucla.edu.
Jazyk: angličtina
Zdroj: Journal of psychiatric research [J Psychiatr Res] 2020 May; Vol. 124, pp. 159-165. Date of Electronic Publication: 2020 Feb 26.
DOI: 10.1016/j.jpsychires.2020.02.028
Abstrakt: Management of Major Depressive Disorder (MDD) might be improved by a biomarker to predict whether a selected medication is likely to lead to remission. We previously reported on a quantitative electroencephalogram-based biomarker, the Antidepressant Treatment Response (ATR) index, that integrated recordings at baseline and after one week of treatment. The present study prospectively tested whether treatment directed by the biomarker increased the likelihood of remission; we hypothesized that continued treatment with a drug predicted to lead to remission (i.e., high ATR values) would be associated with better outcomes than if the drug was predicted not to lead to remission (i.e., low ATR values). We enrolled 180 adult outpatients with unipolar MDD from the community. After one week of escitalopram treatment to determine the biomarker, stratified randomization (high vs. low ATR) was used to assign subjects to either continued escitalopram or a switch to bupropion as a blinded control condition, for seven additional weeks. For the 73 evaluable subjects assigned to continued escitalopram treatment, the remission rate was significantly higher for those in whom ATR had predicted remission versus non-remission (60.4% vs. 30.0%, respectively, p = 0.01). Accuracy was enhanced by combining 1-week depressive symptom change with ATR (68.6% vs 28.9%). This prospective validation study supports further development of the ATR biomarker, alone or together with early symptom change, to improve care by identifying individuals unlikely to remit with their current treatment, and support the decision to change treatment after one week rather than after failing a full, prolonged course of medication.
Competing Interests: Declaration of competing interest As to disclosures, Dr. Cook reports he has received research support from Covidien (formerly Aspect Medical Systems), National Institutes of Health, and NeoSync, Inc. within the past six years; he has been an advisor/consultant/reviewer for Arctica Health, Cerêve, HeartCloud, NeuroDetect, NeuroSigma, NIH (ITVA), U.S. Departments of Defense and Justice, and the VA (DSMB); he is editor of the Patient Management section of the American Psychiatric Association's FOCUS journal; his biomedical intellectual property is assigned to the Regents of the University of California, and he has stock options in NeuroSigma, where he has served as Chief Medical Officer (on leave); at the time of this work, he had been employed by the University of California, Los Angeles and also as a Staff Psychiatrist, Neuromodulation and Mood Disorders programs, Greater Los Angeles Veterans Administration Health System. Dr. Leuchter reports that within the past six years he has received research support from the National Institutes of Health, CHDI Foundation, the Department of Defense, Neuronetics, and NeuroSigma. He has served as a consultant to NeoSync, Inc., Ionis Pharmaceuticals, and Taisho Pharmaceuticals. He is Chief Scientific Officer of Brain Biomarker Analytics LLC (BBA). Dr. Leuchter owns stock options in NeoSync, Inc. and has equity interest in BBA. Drs. Hunter and Caudill and Ms. Abrams report nothing to disclose.
(Copyright © 2020 Elsevier Ltd. All rights reserved.)
Databáze: MEDLINE