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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Enabling Discovery, Development, and Translation of Treatments for Cognitive Dysfunction in Depression: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21745.
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ENABLING DISCOVERY, DEVELOPMENT,
AND TRANSLATION OF TREATMENTS
FOR COGNITIVE DYSFUNCTION
IN DEPRESSION

WORKSHOP SUMMARY

Lisa Bain and Clare Stroud, Rapporteurs

Forum on Neuroscience and
Nervous System Disorders

Board on Health Sciences Policy

Institute of Medicine

images

THE NATIONAL ACADEMIES PRESS

Washington, D.C.

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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Enabling Discovery, Development, and Translation of Treatments for Cognitive Dysfunction in Depression: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21745.
×

THE NATIONAL ACADEMIES PRESS • 500 Fifth Street, NW • Washington, DC 20001

This activity was supported by contracts between the National Academy of Sciences and the Alzheimer’s Association; Brain Canada Foundation; the Department of Health and Human Services’ Food and Drug Administration and National Institutes of Health (NIH, Contract No. HHSN26300026 [Under Master Base #DHHS-10001292]) through the National Center for Complementary and Integrative Health, National Eye Institute, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke, National Institute on Aging, National Institute on Alcohol Abuse and Alcoholism, National Institute on Drug Abuse, and NIH Blueprint for Neuroscience Research; the Department of Veterans Affairs (VA240-14-C-0057); Eli Lilly and Company; Foundation for the National Institutes of Health; the Gatsby Charitable Foundation; GlaxoSmithKline, Inc.; Johnson & Johnson Pharmaceutical Research and Development, LLC; Lundbeck Research USA; Merck Research Laboratories; The Michael J. Fox Foundation for Parkinson’s Research; the National Multiple Sclerosis Society; the National Science Foundation (BCS-1064270); One Mind for Research; Orion Bionetworks; Pfizer Inc.; Pharmaceutical Product Development, LLC; Sanofi; the Society for Neuroscience; Takeda Pharmaceutical Company Limited; and Wellcome Trust. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.

International Standard Book Number-13: 978-0-309-37393-7
International Standard Book Number-10: 0-309-37393-X
DOI: 10.17226/21745

Additional copies of this report are available from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu.

Copyright 2015 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America

Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2015. Enabling discovery, development, and translation of treatments for cognitive dysfunction in depression: Workshop summary. Washington, DC: The National Academies Press.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Enabling Discovery, Development, and Translation of Treatments for Cognitive Dysfunction in Depression: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21745.
×

images

The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institution to advise the nation on issues related to science and technology. Members are elected by their peers for outstanding contributions to research. Dr. Ralph J. Cicerone is president.

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Learn more about the National Academies of Sciences, Engineering, and Medicine at www.national-academies.org.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Enabling Discovery, Development, and Translation of Treatments for Cognitive Dysfunction in Depression: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21745.
×

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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Enabling Discovery, Development, and Translation of Treatments for Cognitive Dysfunction in Depression: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21745.
×

PLANNING COMMITTEE ON ENABLING DISCOVERY,
DEVELOPMENT, AND TRANSLATION OF TREATMENTS FOR
COGNITIVE DYSFUNCTION IN DEPRESSION1

THOMAS INSEL (Co-Chair), National Institute of Mental Health

THOMAS LAUGHREN (Co-Chair), Laughren Psychopharm Consulting, LLC

DEANNA BARCH, Washington University in St. Louis

STEPHEN BRANNAN, Takeda Pharmaceuticals

BRUCE CUTHBERT, National Institute of Mental Health

TIFFANY FARCHIONE, Food and Drug Administration

PHILIP HARVEY, University of Miami Miller School of Medicine

ALAN LESHNER, American Association for the Advancement of Science

RANDALL MORRISON, Janssen Research and Development

JOSEPH PALUMBO, Mitsubishi Tanabe Pharma Development America

DIEGO PIZZAGALLI, Harvard Medical School

WILLIAM RILEY, National Institutes of Health

BARBARA SAHAKIAN, University of Cambridge

TORBJÖRN WAERNER, H. Lundbeck A/S

MOLLY WAGSTER, National Institute on Aging

STEVIN ZORN, Lundbeck Research USA

IOM Staff

CLARE STROUD, Project Director

SHEENA M. POSEY NORRIS, Associate Program Officer

ANNALYN WELP, Senior Program Assistant

ANDREW M. POPE, Director, Board on Health Sciences Policy

_____________

1Institute of Medicine planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Enabling Discovery, Development, and Translation of Treatments for Cognitive Dysfunction in Depression: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21745.
×

This page intentionally left blank.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Enabling Discovery, Development, and Translation of Treatments for Cognitive Dysfunction in Depression: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21745.
×

FORUM ON NEUROSCIENCE AND NERVOUS
SYSTEM DISORDERS1

STEVEN HYMAN (Chair), The Broad Institute of Massachusetts Institute of Technology and Harvard University

STORY LANDIS (Vice Chair), Former Director, National Institute of Neurological Disorders and Stroke

SUSAN AMARA, Society for Neuroscience

STEPHEN BRANNAN, Takeda Pharmaceuticals International, Inc.

KATJA BROSE, Cell Press

DANIEL BURCH, Pharmaceutical Product Development, LLC

SARAH CADDICK, Gatsby Charitable Foundation

ROSA CANET-AVILES, Foundation for the National Institutes of Health

MARIA CARRILLO, Alzheimer’s Association

C. THOMAS CASKEY, Baylor College of Medicine

KAREN CHANDROSS, Sanofi US

TIMOTHY COETZEE, National Multiple Sclerosis Society

FAY LOMAX COOK, National Science Foundation

WILLIAM DUNN, Food and Drug Administration

EMMELINE EDWARDS, National Center for Complementary and Integrative Medicine

MARTHA FARAH, University of Pennsylvania

DANIEL GESCHWIND, University of California, Los Angeles

HANK GREELY, Stanford University

MAGALI HAAS, Orion Bionetworks

RAMONA HICKS, One Mind for Research

RICHARD HODES, National Institute on Aging

STUART HOFFMAN, Department of Veterans Affairs

THOMAS INSEL, National Institute of Mental Health

PHILIP IREDALE, Pfizer Global Research and Development

JOHN ISAAC, Wellcome Trust

INEZ JABALPURWALA, Brain Canada Foundation

FRANCES JENSEN, University of Pennsylvania School of Medicine

GEORGE KOOB, National Institute on Alcohol Abuse and Alcoholism

_____________

1Institute of Medicine forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution.

Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Enabling Discovery, Development, and Translation of Treatments for Cognitive Dysfunction in Depression: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21745.
×

WALTER KOROSHETZ, National Institute of Neurological Disorders and Stroke

ALAN LESHNER, American Association for the Advancement of Science (Emeritus)

HUSSEINI MANJI, Johnson & Johnson Pharmaceutical Research and Development, LLC

DAVID MICHELSON, Merck Research Laboratories

RICHARD MOHS, Lilly Research Laboratories

JAMES OLDS, National Science Foundation

ATUL PANDE, Tal Medical

STEVEN PAUL, Weill Cornell Medical College

TODD SHERER, The Michael J. Fox Foundation for Parkinson’s Research

DAVID SHURTLEFF, National Center for Complementary and Integrative Medicine

PAUL SIEVING, National Eye Institute

NORA VOLKOW, National Institute on Drug Abuse

STEVIN ZORN, Lundbeck Research USA

IOM Staff

BRUCE M. ALTEVOGT, Forum Co-Director (until May 2015)

CLARE STROUD, Forum Co-Director

SHEENA M. POSEY NORRIS, Associate Program Officer

ANNALYN M. WELP, Senior Program Assistant

ANDREW M. POPE, Director, Board on Health Sciences Policy

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Enabling Discovery, Development, and Translation of Treatments for Cognitive Dysfunction in Depression: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21745.
×

Reviewers

This workshop summary has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published workshop summary as sound as possible and to ensure that the workshop summary meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the process. We wish to thank the following individuals for their review of this workshop summary:

CHRISTOPHER BOWIE, Queen’s University

DAN IOSIFESCU, Icahn School of Medicine at Mount Sinai

ANDREW NIERENBERG, Massachusetts General Hospital

RICHARD PORTER, University of Otago, Christchurch

Although the reviewers listed above have provided many constructive comments and suggestions, they did not see the final draft of the workshop summary before its release. The review of this workshop summary was overseen by JOSEPH T. COYLE, Harvard Medical School. He was responsible for making certain that an independent examination of this workshop summary was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this workshop summary rests entirely with the rapporteurs and the institution.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Enabling Discovery, Development, and Translation of Treatments for Cognitive Dysfunction in Depression: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21745.
×

This page intentionally left blank.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Enabling Discovery, Development, and Translation of Treatments for Cognitive Dysfunction in Depression: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21745.
×
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Enabling Discovery, Development, and Translation of Treatments for Cognitive Dysfunction in Depression: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21745.
×
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Enabling Discovery, Development, and Translation of Treatments for Cognitive Dysfunction in Depression: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21745.
×
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Enabling Discovery, Development, and Translation of Treatments for Cognitive Dysfunction in Depression: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21745.
×
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Enabling Discovery, Development, and Translation of Treatments for Cognitive Dysfunction in Depression: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21745.
×
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Enabling Discovery, Development, and Translation of Treatments for Cognitive Dysfunction in Depression: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21745.
×
Page R5
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Enabling Discovery, Development, and Translation of Treatments for Cognitive Dysfunction in Depression: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21745.
×
Page R6
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Enabling Discovery, Development, and Translation of Treatments for Cognitive Dysfunction in Depression: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21745.
×
Page R7
Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Enabling Discovery, Development, and Translation of Treatments for Cognitive Dysfunction in Depression: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21745.
×
Page R8
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Enabling Discovery, Development, and Translation of Treatments for Cognitive Dysfunction in Depression: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21745.
×
Page R9
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Enabling Discovery, Development, and Translation of Treatments for Cognitive Dysfunction in Depression: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21745.
×
Page R10
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Enabling Discovery, Development, and Translation of Treatments for Cognitive Dysfunction in Depression: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21745.
×
Page R11
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Enabling Discovery, Development, and Translation of Treatments for Cognitive Dysfunction in Depression: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21745.
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Page R12
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 Enabling Discovery, Development, and Translation of Treatments for Cognitive Dysfunction in Depression: Workshop Summary
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Major depressive disorder (MDD) is recognized worldwide as a major cause of disability, morbidity, and mortality. According to the World Health Organization, unipolar depressive disorders affect more than 150 million people around the world and represent the leading cause of years lost due to disability among both men and women. In the United States alone, nearly 8 percent of persons over the age of 12 report current depression. MDD has long been defined primarily as a mood disorder. However,more recently people have begun to recognize effects on cognition as a major contributor to the disablement that accompanies depression and to consider this an underrecognized treatment target for depression.

To explore how best to enable the discovery, development, and translation of treatments for cognitive dysfunction in depression, including a focus on the regulatory path forward, the Institute of Medicine's Forum on Neuroscience and Nervous Disorders convened key stakeholders at a workshop in February 2015. This report summarizes the presentations from expert speakers and discussions among workshop participants.

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