This course is designed for pharmacists, nurse practitioners or other health care professionals involved in the comprehensive medication management of psychiatric and/or neurological patients.
Session Summary
With poor remission rates and unpredictable antidepressant response, identification of treatment response markers can have a significant impact on the personalized care of depression. The Establishing Moderators and Biosignatures of Antidepressant Response for Clinical Care (EMBARC) trial seeks to improve upon the existing limitations of antidepressant treatment selection and optimization. This session will review the premise of the EMBARC trial, discuss results thus far, and provide participants with an understanding of the future of personalized medicine in the treatment of depression.
Course Requirements
You will proceed through the following steps to satisfactorily complete this course:
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Review the full content of the activity and reflect upon its teachings.
Complete the post-test at the end of the activity no later than the closing activity date.
Complete the evaluation at the end of the activity.
If necessary, complete the post-test retest no later than the closing activity date.
Receive a passing grade (70%).
Provide the necessary details in your profile to ensure correct reporting by AAPP to CPE Monitor.
Participants in this course must complete an examination and achieve a score of 70% or greater. Successful completion of the course also requires the completion of a course evaluation. Upon successful completion, ACPE credit is reported immediately to CPE Monitor although transcripts can be retrieved by participants online at https://aapp.org/mycpnp/transcript/acpe.
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Madhukar H. Trivedi, MD
Professor, Chief of the Division of Mood Disorders
Director of the Comprehensive Center for Depression
Department of Psychiatry, UT Southwestern Medical Center
Dallas, TX
Madhukar H. Trivedi, M.D. is currently a Professor and Chief of the Division of Mood Disorders in the Department of Psychiatry at the University of Texas Southwestern Medical Center at Dallas. He holds the Betty Jo Hay Distinguished Chair in Mental Health. Dr. Trivedi is an established efficacy and effectiveness researcher in the treatment of depression. Dr. Trivedi has focused his research on pharmacological, psychosocial, and other nonpharmacological treatments for depression. Dr. Trivedi has been a principal investigator in multiple clinical trials funded through NIMH and the Texas Department of Mental Health. He is the Principal Investigator of the NIDA-funded “Stimulant Reduction Intervention using Dosed Exercise (STRIDE)” study that tests the effectiveness of adding exercise to treatment as usual in improving drug treatment outcomes. Dr. Trivedi is also Principal Investigator of the Texas Node of the NIDA-funded Clinical Trials Network. Additionally, he was the Principal Investigator of three NIMH grants entitled “CBASP Augmentation for Treatment of Chronic Depression (REVAMP),” “TReatment with Exercise Augmentation for Depression (TREAD),” and “Computerized Decision Support System for Depression (CDSS-D).” He was the Principal Investigator of the Depression Trials Network “Combining Medications to Enhance Depression Outcomes (CO-MED)” trial, which focused on the use of specific antidepressant combinations to increase remission rates by treating a broader spectrum of depressed patients and by capitalizing on additive pharmacological effects. He was also the Co-Principal Investigator of the NIMH-funded project entitled “Sequenced Treatment Alternatives to Relieve Depression (STAR*D).”
Most recently, Dr. Trivedi has been selected to Lead the team conducting the EMBARC project. This project is at the core of the NIMH’s initiative to identify a biosignature for depression. This work will focus on neuroimaging, EEG, clinical and behavioral phenotypes and other blood-based biological markers. His ongoing work as the Lead PI of the EMBARC study provides an extensive background for his contribution to the Neurobiological Markers employed in the study. Note this grant is designed to be a linchpin in the development of a biosignature for depression and is unique in its design to evaluate biomarkers from across full spectrum possible biological markers. As the lead site, he will be able to provide new clinical research opportunities to work at cutting edge of translational research in depression.
Dr. Trivedi has received numerous awards including the Gerald L. Klerman award from the National Depressive and Manic-Depressive Association Scientific Advisory Board-NDMDA and the Psychiatric Excellence Award from the Texas Society of Psychiatric Physicians-TSPP. Dr. Trivedi has mentored multiple psychopharmacology postdoctoral fellows and research track residents over the past many years in Mood and Anxiety Disorders and is the Principal Investigator of an NIMH-funded Postdoctoral T32 training program. He is or has been a member of several institutional review groups of the NIMH. Dr. Trivedi has published over 380 articles and chapters related to the Diagnosis and Treatment of Mood Disorders.
Faculty Disclosures
Consultant: ACADIA Pharmaceutcals, Inc, Alkermes, Inc, Akili Interactive, Allergan Pharmaceuticals, American Society of Clinical Psychopharmacology (ASCP), American Psychiatric Association (APA), Axsome Therapeutics, Boehringer Ingelheim, Engage Health Media, Janssen, Jazz Pharmaceuticals, Lundbeck Research USA, Medscape LLC, Navitor, Otsuka America Pharmaceutical Inc., Oxford Pharmagenesis, Perception Neuroscience Holdings, Saatchi, SAGE Therapeutics, Takeda Global Research
Financial: The EMBARC study (NCT01407094) was supported by the National Institute of Mental Health of the National Institutes of Health under award numbers U01MH092221 (Trivedi, M.H.) and U01MH092250 (McGrath, P.J., Parsey, R.V., Weissman, M.M.), and in part by the Hersh Foundation. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Valeant Pharmaceuticals donated the Wellbutrin XL used in the study. This work was supported by the EMBARC National Coordinating Center at UT Southwestern Medical Center, Madhukar H. Trivedi, M.D., Coordinating PI, and the Data Center at Columbia and Stony Brook Universities.
Presentation will include discussion of off-label, experimental, and/or investigational use of drugs or devices: None
Affiliation: Research Activities: NIMH, NIDA, J&J, Janssen Research and Development LLC
All relevant relationships have been mitigated.
Learning Objectives
Discuss the “markers” and “moderators” selected for the Establishing Moderators and Biosignatures of Antidepressant Response for Clinical Care (EMBARC) trial and how these may impact treatment response.
Summarize initial findings of the EMBARC trial and the impact these data have on clinical care.
Describe the role of biosignatures, such as the Depression Treatment Response Index, in the personalized care of depression.
Review ongoing and future research related to the EMBARC trial.
Continuing Education Credit and Disclosures
Activity Dates:05/16/2019 - 04/09/2022 ACPE Contact Hours: 1 ACPE Number: 0284-0000-19-023-H01-P (Knowledge) Nursing Credit Reminder: Note that ACPE credit is accepted for certification renewal.
The College of Psychiatric and Neurologic Pharmacists is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This course provides 1.0 contact hour of knowledge-based continuing education credit from CPNP approved programming.
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Off-Label Use: This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA (see faculty information and disclosures). The opinions expressed in the educational activity do not necessarily represent the views of AAPP and any educational partners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
Disclaimer: Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications on dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
It is the policy of AAPP to ensure independence, balance, objectivity, scientific rigor, and integrity in continuing education activities. Those involved in the development of this continuing education activity have made all reasonable efforts to ensure that information contained herein is accurate in accordance with the latest available scientific knowledge at the time of accreditation of this continuing education activity. Information regarding drugs (e.g., their administration, dosages, contraindications, adverse reactions, interactions, special warnings, and precautions) and drug delivery systems is subject to change, however, and the reader is advised to check the manufacturer’s package insert for information concerning recommended dosage and potential problems or cautions prior to dispensing or administering the drug or using the drug delivery systems.
Fair balance is achieved through ongoing and thorough review of all materials produced by faculty, and all educational and advertising materials produced by supporting organizations, prior to educational offerings. Approval of credit for this continuing education activity does not imply endorsement by AAPP for any product or manufacturer identified.
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The College of Psychiatric and Neurologic Pharmacists is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This course provides 1.0 contact hour of knowledge-based continuing education credit from CPNP approved programming.