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PRACTICE GUIDELINE FOR THE

Treatment of Patients With Major Depressive Disorder

Third Edition

WORK GROUP ON MAJOR DEPRESSIVE DISORDER

Alan J. Gelenberg, M.D., Chair

Marlene P. Freeman, M.D.

John C. Markowitz, M.D.

Jerrold F. Rosenbaum, M.D.

Michael E. Thase, M.D.

Madhukar H. Trivedi, M.D.

Richard S. Van Rhoads, M.D., Consultant

INDEPENDENT REVIEW PANEL

Victor I. Reus, M.D., Chair

J. Raymond DePaulo, Jr., M.D.

Jan A. Fawcett, M.D.

Christopher D. Schneck, M.D.

David A. Silbersweig, M.D.

This practice guideline was approved in May 2010 and published in October 2010. A guideline watch, summarizing significant developments in the scientific literature since publication of this guideline, may be available at

http://www.psychiatryonline.com/pracGuide/pracGuideTopic_7.aspx.

Copyright 2010, American Psychiatric Association. APA makes this practice guideline freely available to promote its dissemination and use; however, copyright protections are enforced in full. No part of this guideline may be reproduced except as permitted under Sections 107 and 108 of U.S. Copyright Act. For permission for reuse, visit APPI Permissions & Licensing Center at http://www.appi.org/CustomerService/Pages/Permissions.aspx.

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

The Work Group on Major Depressive Disorder reports the following potentially competing interests for the pe- riod from May 2005 to May 2010:

Dr. Gelenberg reports consulting for Eli Lilly and Com- pany, Pfizer, Best Practice, AstraZeneca, Wyeth, Cyber- onics, Novartis, Forest Pharmaceuticals, Inc., GlaxoSmith- Kline, ZARS Pharma, Jazz Pharmaceuticals, Lundbeck, Takeda Pharmaceuticals North America, Inc., eResearch Technology, Dey Pharma, PGxHealth, and Myriad Genet- ics. He reports serving on speakers bureaus for Pfizer, GlaxoSmithKline, and Wyeth. He reports receiving re- search grant funding from Eli Lilly and Company, Pfizer, and GlaxoSmithKline. He reports stock ownership in Healthcare Technology Systems. Dr. Freeman reports that she received research support from the Meadows Foundation, the National Institute for Mental Health, the U.S. Food and Drug Administration, the Institute for Mental Health Research, Forest, Glaxo- SmithKline and Eli Lilly and Company (investigator- initiated trials), and Pronova Biocare (research materials). She received an honorarium for case-based peer-reviewed material for AstraZeneca’s website. She reports consulting for Ther-Rx, Reliant, and Pamlab. She reports receiving an honorarium for speaking at an APA continuing medical education program that was sponsored by Forest and an honorarium for speaking at a continuing medication edu- cation program sponsored by KV Pharmaceuticals. She reports receiving an honorarium from Leerink Swann for participating in a focus group. Dr. Markowitz reports consulting for Ono Pharma- ceutical Co., Ltd. (2005). He reports receiving research support from Forest Pharmaceuticals, Inc. (2005). He re- ports receiving grant support from the National Institute of Mental Health (2005–2013), the National Alliance for Research in Schizophrenia and Depression (2005), and MINT: Mental Health Initiative (2005). He reports re- ceiving royalties from American Psychiatric Publishing, Inc. (2005–2010), Basic Books (2005–2010), Elsevier (2005– 2010), and Oxford University Press (2007–2010). Dr. Rosenbaum reports attending advisory boards for Bristol-Myers Squibb, Cephalon, Cyberonics, Forest Phar- maceuticals, Inc., Eli Lilly and Company, MedAvante, Neuronetics, Inc., Novartis, Orexigen Therapeutics, Inc., Organon BioSciences, Pfizer, Roche Diagnostics, Sanofi- aventis, Shire, and Wyeth. He reports consulting for Aus- pex Pharmaceuticals, Compellis Pharmaceuticals, EPIX Pharmaceuticals, Neuronetics, Inc., Organon BioSci- ences, Somaxon, and Supernus Pharmaceuticals, Inc. He

reports receiving honoraria from lectureships for Boeh- ringer Ingleheim, Bristol-Myers Squibb, Cyberonics, Forest Pharmaceuticals, Inc., Eli Lilly and Company, and Schwartz Pharma. He was involved in the creation of the Massachusetts General Hospital Psychiatry Academy (MGH-PA) and has served as a panelist in four satellite broadcast programs. MGH-PA programs that have indus- try support are always multi-sponsored, and curriculum development by the Academy is independent of sponsor- ship; the curricula from January 2005 to March 2009 in- cluded sponsorship support from AstraZeneca, Bristol- Myers Squibb, Cephalon, Eli Lilly and Company, Forest Pharmaceuticals, Inc., GlaxoSmithKline, Janssen Medical Affairs LLC, Ortho-McNeil Pharmaceutical, sanofi- aventis, Shire, and Wyeth. He reports equity holdings in Compellis Pharmaceuticals, MedAvante, and Somaxon. Dr. Thase reports that he provided scientific consulta- tion to AstraZeneca, Bristol-Myers Squibb, Eli Lilly & Company, Forest Pharmaceuticals, Inc., Gerson Lehman Group, GlaxoSmithKline, Guidepoint Global, H. Lund- beck A/S, MedAvante, Inc., Neuronetics, Inc., Novartis, Otsuka, Ortho-McNeil Pharmaceuticals, PamLab, L.L.C., Pfizer (formerly Wyeth-Ayerst Laboratories), Schering- Plough (formerly Organon), Shire U.S., Inc., Supernus Pharmaceuticals, Takeda (Lundbeck), and Transcept Phar- maceuticals. He was a member of the speakers bureaus for AstraZeneca, Bristol-Myers Squibb, Eli Lilly and Com- pany, GlaxoSmithKline, Pfizer (formerly Wyeth-Ayerst Laboratories), and Schering-Plough (formerly Organon). He received grant funding from Eli Lilly and Company, GlaxoSmithKline, the National Institute of Mental Health, the Agency for Healthcare Research and Quality, and Sepracor, Inc. He had equity holdings in MedAvante, Inc., and received royalty income from American Psychiatric Publishing, Inc., Guilford Publications, Herald House, Oxford University Press, and W.W. Norton and Company. His wife was employed as the group scientific director for Embryon (formerly Advogent), which does business with Bristol-Myers Squibb and Pfizer/Wyeth. Dr. Trivedi reports that he was a consultant to or on speaker bureaus for Abbott Laboratories, Inc., Abdi Ibra- him, Akzo (Organon Pharmaceuticals, Inc.), AstraZeneca, Bristol-Myers Squibb Company, Cephalon, Inc., Cyber- onics, Inc., Eli Lilly and Company, Evotec, Fabre Kramer Pharmaceuticals, Inc., Forest Pharmaceuticals, Glaxo- SmithKline, Janssen Pharmaceutica Products, L.P., Johnson & Johnson P.R.D., Meade-Johnson, Medtronic, Neuro- netics, Otsuka Pharmaceuticals, Parke-Davis Pharmaceuti-

Copyright 2010, American Psychiatric Association. APA makes this practice guideline freely available to promote its dissemination and use; however, copyright protections are enforced in full. No part of this guideline may be reproduced except as permitted under Sections 107 and 108 of U.S. Copyright Act. For permission for reuse, visit APPI Permissions & Licensing Center at http://www.appi.org/CustomerService/Pages/Permissions.aspx.

cals, Inc., Pfizer, Inc., Sepracor, Shire Development, Solvay Pharmaceuticals, VantagePoint, and Wyeth-Ayerst Labo- ratories. He received research support from the Agency for Healthcare Research and Quality, Corcept Therapeutics, Inc., Cyberonics, Inc., Merck, National Alliance for Re- search in Schizophrenia and Depression, National Insti- tute of Mental Health, National Institute on Drug Abuse, Novartis, Pharmacia & Upjohn, Predix Pharmaceuticals (Epix), Solvay Pharmaceuticals, Inc., and Targacept. Dr. Van Rhoads reports no competing interests. The Independent Review Panel, including Drs. Reus, DePaulo, Fawcett, Schneck, and Silbersweig, report no

competing interests. The Independent Review Panel re- viewed this guideline to assess potential biases and found no evidence of influence from the industry and other re- lationships of the Work Group disclosed above. The Steering Committee on Practice Guidelines also reviewed this guideline and found no evidence of influence from these relationships. The development process for this guideline, including the roles of the Work Group, Inde- pendent Review Panel, Steering Committee, APA Assem- bly, and APA Board of Trustees is described in “Overview of Guideline Development Process” on p. 11.

Copyright 2010, American Psychiatric Association. APA makes this practice guideline freely available to promote its dissemination and use; however, copyright protections are enforced in full. No part of this guideline may be reproduced except as permitted under Sections 107 and 108 of U.S. Copyright Act. For permission for reuse, visit APPI Permissions & Licensing Center at http://www.appi.org/CustomerService/Pages/Permissions.aspx.

AMERICAN PSYCHIATRIC ASSOCIATION STEERING COMMITTEE ON PRACTICE GUIDELINES

John S. McIntyre, M.D., Chair (1999–2009), Consultant (2009–2010) Joel Yager, M.D., Vice-Chair (2008–2009), Chair (2009–2010) Daniel J. Anzia, M.D. Thomas J. Craig, M.D., M.P.H. Molly T. Finnerty, M.D. Bradley R. Johnson, M.D. Francis G. Lu, M.D. James E. Nininger, M.D., Vice-Chair (2009–2010) Barbara Schneidman, M.D. Paul Summergrad, M.D. Sherwyn M. Woods, M.D., Ph.D. Michael J. Vergare, M.D. M. Justin Coffey, M.D. (fellow) Kristen Ochoa, M.D. (fellow) Jeremy Wilkinson, M.D. (fellow) Sheila Hafter Gray, M.D. (liaison)

STAFF

Robert Kunkle, M.A., Director, Practice Guidelines Project Robert M. Plovnick, M.D., M.S., Director, Dept. of Quality Improvement and Psychiatric Services Darrel A. Regier, M.D., M.P.H., Director, Division of Research

MEDICAL EDITOR

Laura J. Fochtmann, M.D.

Copyright 2010, American Psychiatric Association. APA makes this practice guideline freely available to promote its dissemination and use; however, copyright protections are enforced in full. No part of this guideline may be reproduced except as permitted under Sections 107 and 108 of U.S. Copyright Act. For permission for reuse, visit APPI Permissions & Licensing Center at http://www.appi.org/CustomerService/Pages/Permissions.aspx.

CONTENTS

STATEMENT OF INTENT

 

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. 11

OVERVIEW OF GUIDELINE DEVELOPMENT

 

11

GUIDE TO USING THIS PRACTICE GUIDELINE

 

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. 13

OFF-LABEL USE OF MEDICATIONS

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. 13

INTRODUCTION

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. 13

PART A: TREATMENT RECOMMENDATIONS

 

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15

I. EXECUTIVE SUMMARY

 

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. 15

A. Coding System

 

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. 15

B. Summary of Recommendations

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. 15

 

1. Psychiatric management

 

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15

 

a. Establish and maintain a therapeutic alliance

 

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15

b. Complete the psychiatric assessment

 

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c. Evaluate the safety of the patient

 

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15

d. Establish the appropriate setting for treatment

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16

e. Evaluate functional impairment and quality of life

 

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f. Coordinate the patient’s care with other clinicians

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g. Monitor the patient’s psychiatric status

 

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16

h. Integrate measurements into psychiatric management

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16

 

i. Enhance treatment adherence

 

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16

j. Provide education to the patient and the family

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16

 

2. Acute phase

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17

 

a. Choice of an initial treatment modality

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17

 

1. Pharmacotherapy

 

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17

2. Other somatic therapies

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3. Psychotherapy

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17

4. Psychotherapy plus antidepressant medication

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18

 

b. Assessing the adequacy of treatment response

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18

c. Strategies to address nonresponse

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18

 

3. Continuation phase

 

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19

4. Maintenance phase

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19

5. Discontinuation of treatment

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20

6. Clinical factors influencing treatment

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20

 

a. Psychiatric factors

 

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20

b. Demographic and psychosocial factors

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20

c. Co-occurring general medical conditions

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21

II. FORMULATION AND IMPLEMENTATION OF A TREATMENT PLAN

 

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. 22

A.

Psychiatric Management

 

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1. Establish and maintain a therapeutic alliance

 

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2. Complete the psychiatric

 

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Copyright 2010, American Psychiatric Association. APA makes this practice guideline freely available to promote its dissemination and use; however, copyright protections are enforced in full. No part of this guideline may be reproduced except as permitted under Sections 107 and 108 of U.S. Copyright Act. For permission for reuse, visit APPI Permissions & Licensing Center at http://www.appi.org/CustomerService/Pages/Permissions.aspx.

 

3.

Evaluate the safety of the patient

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. 25

4.

Establish the appropriate setting for treatment

 

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5.

Evaluate functional impairment and quality of life

 

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6.

Coordinate the patient’s care with other clinicians

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