Mixed Features in Depressive Episodes: Managing Patients Across the

Managing Patients Across the Disease Spectrum

JOSEPH R.

Calabrese, MD

GARY

Sachs, MD

MICHAEL E. Thase, MD

Jointly provided by North American Center for Continuing Medical Education, LLC, an HMP Communications Holdings Company, and Integritas Communications.

This activity is supported by an educational grant from Sunovion Pharmaceuticals, Inc. First-come, first-served. Admittance is based on availability and not guaranteed.

CME/MEDICAL COMMUNICATIONS INQUIRIES info@integritasgrp.com integritasgrp.com

FACULTY FACULTY

JOSEPH R. Calabrese, MD Bipolar Disorders Research Chair Professor, Department of Psychiatry Director, Mood Disorders Program University Hospitals Case Medical Center Case Western Reserve University School of Medicine Cleveland, Ohio

GARY Sachs, MD Associate Clinical Professor of Psychiatry Harvard Medical School Founding Director, Bipolar Clinic and Research Program Massachusetts General Hospital Boston, Massachusetts

MICHAEL E. Thase, MD Professor of Psychiatry Director, Mood and Anxiety Disorders Treatment and Research Program University of Pennsylvania Perelman School of Medicine Philadelphia, Pennsylvania

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INTENDED LEARNERS This activity is designed for psychiatrists, primary care physicians, psychologists, nurse practitioners, physician assistants, psychiatric nurses, and other healthcare professionals involved in treating patients with depressive presentations.

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LEARNING OBJECTIVES Upon completion of the activity, participants should be able to: • Differentially diagnose depressive mental illnesses, focusing on new DSM-5 specifiers and various patient presentations along the disease continuum • Treat depressive episodes based on all presenting symptoms, overall health status, and evidence for medication efficacy and safety • Tailor therapy to patients with depressive episodes and complicating factors, such as mixed features, comorbid Axis I disorders, and other aspects of overall patient health • Educate patients and caregivers on treatment options, self-management strategies, and treatment adherence

AGENDA 12:45 pm – 12:50 pm Introductions and Preactivity Questionnaire 12:50 pm – 1:05 pm

Evolving View of Mood Disorders

1:05 pm – 1:20 pm

Differential Diagnosis of Depressive Episodes

1:20 pm – 1:35 pm Therapeutic Options for Depression With Mixed Features 1:35 pm – 1:50 pm

Choose-a-Case: Practical Strategies for Patient Care

1:50 pm – 2:00 pm Postactivity Questionnaire and Question-and-Answer Session

ACCREDITATION INFORMATION This activity has been planned and implemented by North American Center for Continuing Medical Education (NACCME) and Integritas Communications.

NACCME is accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.

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CME NACCME designates this live activity for a maximum of 1.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

CNE This continuing nursing education activity awards 1.25 contact hours.

NURSING PHARMACOLOGY CREDITS This continuing nursing educational activity awards up to 0.5 pharmacology hours.

APA North American Center for Continuing Medical Education, LLC (NACCME) is approved by the American Psychological Association to sponsor continuing education for psychologists. NACCME maintains responsibility for this program and its content.

Instructional Level: Advanced For complete faculty bios, please call 609-371-1137.

INSTRUCTIONS FOR PARTICIPANTS TO COMPLETE SESSION EVALUATION AND RECEIVE DOCUMENTATION OF CREDIT To confirm participation and receive CME/CE credit, attendees are required to complete activity evaluations for each session attended. After you attend your sessions, please log on to https://myexpocredits.expologic.com/naccme. You will need your badge ID, which is located on your 2015 Psych Congress badge.

Your password is PSY2015. Session ID: TS2 We ask that you please enter your evaluations by October 13, 2015.

After logging in, follow the instructions on the screen to complete your evaluations. After completing all relevant session evaluations, attendees must complete a Psych Congress 2015 General Survey before credits can be claimed.

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Provider approved by the California Board of Registered Nursing, Provider #13255 for 1.25 contact hours.

HARDWARE/SOFTWARE REQUIREMENTS The evaluation is accessible after the activity via a PC (Windows 2000/XP/ Vista/7) or Mac (Mac OS 10.x or later) computer with current versions of the following browsers: Internet Explorer, Mozilla Firefox, Google Chrome, or Safari. A PDF reader is required for print publications. Please direct technical questions to webmaster@naccme.com.

There is no fee associated with this activity.

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For questions regarding this educational activity, please call 609-371-1137.

Independent Clinical Reviewer: William C. Torrey, MD, Professor of Psychiatry, Vice Chair for Clinical Services, Department of Psychiatry, Grisel School of Medicine at Dartmouth, Lebanon, New Hampshire Nurse Planner: Andrew Penn, RN, MS, NP, CNS, APRN-BC, Psychiatric Nurse Practitioner, Kaiser Permanente, Redwood City, California; Assistant Clinical Professor, University of California, San Francisco, California

PLANNING COMMITTEE The planning committee comprises faculty members Joseph Calabrese, MD; Gary Sachs, MD; Michael Thase, MD; Nurse Planner Andrew Penn, RN, MS, NP, CNS, APRN-BC; William C. Torrey, MD; Educational Partner Rose O’Connor, PhD; and Raquel Gaerlan, Mike Kearney, Meaghan O’Brien, Randy Robbin, and John Savage, NACCME.

FINANCIAL DISCLOSURE AND CONFLICTS OF INTEREST According to the disclosure policy of NACCME, faculty, editors, managers, and other individuals who are in a position to control content are required to disclose any relevant financial relationships with relevant commercial companies related to this activity. All relevant conflicts of interest that are identified are reviewed for potential conflicts of interest. If a conflict is identified, it is the responsibility of NACCME to initiate a mechanism to resolve the conflict(s). The existence of these interests or relationships is not viewed as implying bias or decreasing the value of the presentation.

All educational materials are reviewed for fair balance, scientific objectivity of studies reported, and levels of evidence.

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Dr. Calabrese is a consultant to Dainippon Sumitomo Pharma Co., Ltd, Forest Laboratories, Inc.; GlaxoSmithKline plc; Janssen Pharmaceuticals, Inc.; Medscape; Sunovion Pharmaceuticals Inc.; and Takeda Pharmaceutical Company Ltd. Dr. Sachs is the owner and part-time employee of Collaborative Care Initiative and full-time employee of Bracket. Dr. Sachs is a consultant and advisory board member for Sunovion Pharmaceuticals Inc. and Takeda Pharmaceutical Company Ltd. Dr. Sachs is a shareholder of athenahealth, Inc. and Express Scripts.

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Dr. Thase receives grant/research support from the Agency for Healthcare Research and Quality; Alkermes plc; AssureRx; Avanir Pharmaceuticals, Inc.; Forest Laboratoriess, Inc.; Janssen Pharmaceuticals, Inc.; National Institute of Mental Health (NIMH); and Otsuka Pharmaceutical Co., Ltd. Dr. Thase is an adviser/consultant for Alkermes; Allergan; AstraZeneca; Bristol-Myers Squibb Company; Cerecor Inc.; Eli Lilly and Company; Fabre-Kramer Pharmaceuticals, Inc.; Forest Laboratories, Inc.; Gerson Lehrman Group, Inc.; GlaxoSmithKline plc; Guidepoint Global, LLC; H. Lundbeck A/S, MedAvante, Inc.; Merck & Co., Inc. (formerly Schering Plough and Organon); moksha8 Pharmaceuticals Inc.; Naurex Inc., Neuronetics, Inc.; Novartis AG; Ortho-McNeil Pharmaceuticals (Johnson & Johnson; Janssen); Otsuka Pharmaceutical Co., Ltd.; Pamlab, Inc. (Nestle); Pfizer Inc.; Shire US Inc; Sunovion Pharmaceuticals Inc.; Trius Therapeutics, Inc.; and Takeda Pharmaceutical Company Ltd. He has equity holdings in MedAvante, Inc; royalties from American Psychiatric Foundation, Guildford Publications, Inc.; Herald Publishing House, and W.W. Norton & Company, Inc; and Spouse’s Employment is with Peloton Advantage, LLC. Mr. Penn and Dr. Torrey disclosed no relevant financial relationships with any commercial interests.

Ms. Gaerlan, Mr. Kearney, Ms. O’Brien, Mr. Robbin, Mr. Savage; Dr. O’Connor disclosed no relevant financial relationships with any commercial interests.

NACCME requires faculty to inform participants whenever off-label/ unapproved uses of drugs and/or devices are discussed in their presentations.

The off-label or investigational use of Lurasidone and Lamotrigine for the treatment of depression with mixed features will be discussed.

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PRIVACY POLICY NACCME protects the privacy of personal and other information regarding participants, educational partners, and joint sponsors. NACCME and our joint sponsors will not release personally identifiable information to a third party without the individual’s consent, except such information as is required for reporting purposes to the appropriate accrediting agency.

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NACCME maintains physical, electronic, and procedural safeguards that comply with federal regulations to guard your nonpublic personal information.

Copyright Š 2015 by North American Center for Continuing Medical Education, LLC. All rights reserved. No part of this accredited continuing education activity may be reproduced or transmitted in any form or by any means, electronic or mechanical, without first obtaining permission from North American Center for Continuing Medical Education. The opinions expressed in this educational activity are those of the faculty and are not attributable to NACCME. Clinical judgment must guide each professional in weighing the benefits of treatment against the risk of toxicity. Dosages, indications, and methods of use for products referred to in this activity are not necessarily the same as indicated in the package insert for each product, may reflect the clinical experience of the presenters, and may be derived from the professional literature or other clinical sources. Consult complete prescribing information before administering.

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GUIDELINES »» Diagnostic and Statistical Manual of Mental Disorders (Fifth edition).

American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders (Fifth edition). 2013: Arlington, VA, American Psychiatric Publishing. http://www.dsm5.org/Pages/Default.aspx

»» The American Psychiatric Association Practice Guidelines for the Psychiatric Evaluation of Adults (Third edition). 2016: Arlington, VA, American Psychiatric Publishing. http://psychiatryonline.org/doi/pdf/10.1176/appi.books.9780890426760

CLINICAL TOOLS »» Montgomery-Asberg Depression Rating Scale (MADRS) This clinician-scored questionnaire assesses the severity of patient depression over the prior week on a scale of 0-6, where 0 denotes no symptoms and 6 indicates the most severe symptoms (Montgomery SA, Asberg M. Brit J Psychiat.

1979;134:382-389). http://www.psy-world.com/madrs.htm

»» Young Mania Rating Scale (YMRS) This clinician-guided assessment is intended to identify the severity of patient abnormalities. The 11-statement assessment is used to describe the patient’s symptoms over the prior week through scoring on a 0-4 scale, where 0 is absence of symptoms (feeling normal) and 4 indicates the most severe symptoms (Young RC, et al. Br J Psychiatry. 1978;133(5):429-435).

»» Clinically Useful Depression Outcome Scale with questions for the DSM-5 mixed features specifier (CUDOS-M) This self-administered assessment scale detects the presence of mixed features in patients with major depressive disorder. With a rating scale of 0-4, where 0 is not at all true and 4 is almost always true, patients endorse the frequency of each symptom experienced during the prior week (Zimmerman M, et al. J Affect Disord.

2014;168:357-362). http://www.ncbi.nlm.nih.gov/pubmed/25103631

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RESOURCE CENTER

http://www.psych.uic.edu/csp/images/stories/physicians/rating%20scales/YMRS.pdf

PATIENT RESOURCE »» Depression and Bipolar Support Alliance The Depression and Bipolar Support Alliance (DBSA) offers resources for patients, materials for clinicians, information on mental health research, as well as listings of patient support groups across the United States. http://www.dbsalliance.org/site/PageServer?pagename=home

SUGGESTED READING »» Mixed specifier for bipolar mania and depression: highlights of DSM-5 changes and implications for diagnosis and treatment in primary care.

Hu J, et al. Prim Care Companion CNS Disord. 2014;16(2). http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4116292/

»» Heterogeneity of DSM-IV Major Depressive Disorder as a Consequence of Subthreshold Bipolarity Zimmermann P, et al. Arch Gen Psychiatry. 2009;66(12):1341-1352. http://archpsyc.jamanetwork.com/article.aspx?articleid=210481

»» A 6 Week Randomized Double-Blind Placebo-Controlled Trial of Ziprasidone for the Acute Depressive Mixed State.

Patkar A, et al. Plos ONE. 2012;7(4):e34757. http://www.plosone.org/article/fetchObject.action?uri=info:doi/10.1371/journal. pone.0034757&representation=PDF

RESOURCE CENTER

»» The prevalence and illness characteristics of DSM-5-defined “mixed feature specifier” in adults with major depressive disorder and bipolar disorder: Results from the International Mood Disorders Collaborative Project.

McIntyre RS, et al. J Affect Disord. 2014;12(172C):259-264. http://www.ncbi.nlm.nih.gov/pubmed/25451425

»» Efficacy of olanzapine monotherapy in the treatment of bipolar depression with mixed features.

Tohen M, et al. J Affect Disord. 2014;164:57-62. http://www.ncbi.nlm.nih.gov/pubmed/24856554

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»» Mixed features in patients with a major depressive episode: the BRIDGE-II-MIX study.

Perugi G, et al. J Clin Psychiatry. 2015;76(3):e351-e358. http://www.ncbi.nlm.nih.gov/pubmed/25830457

»» Lurasidone in the treatment of bipolar depression with mixed (subsyndromal hypomanic) features: post hoc analysis of a randomized placebo-controlled trial.

McIntyre RS, et al. J Clin Psychiatry. 2015;76(4):398-405.

RESOURCE CENTER

http://www.psychiatrist.com/JCP/article/ _ layouts/ppp.psych.controls/BinaryViewer.ashx?Article=/ jcp/article/Pages/2015/v76n04/v76n0402.aspx&Type=Article

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Please visit the CLINICAL RESOURCE CENTER for additional information and resources

www.ExchangeCME.com/MIXED2015

Š 2015 North American Center for Continuing Medical Education, LLC, an HMP Communications Holdings Company and Integritas Communications. All rights reserved.

No part of this syllabus may be used or reproduced in any manner whatsoever without written permission except in the case of brief quotations embedded in articles or reviews.