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Suggested Citation:"Appendix B: Workshop Agenda." 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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B

Workshop Agenda

Enabling Discovery, Development, and Translation of Treatments for Cognitive Dysfunction in Depression: A Workshop

February 24, 2015

National Academy of Sciences
2101 Constitution Avenue, Room 120
Washington, DC 20418

Background: It is increasingly recognized that many patients, while fulfilling traditional criteria for response or remission of depression, continue to have subjective complaints and have difficulties returning to their previous level of function (e.g., returning to work). Increasing clinical and epidemiologic evidence suggests that cognitive dysfunction is an underestimated dimension of depression. Such dysfunction could, in part, explain patients’ poor response and/or poor functional outcomes. Currently available pharmacological treatments appear to only address cognitive dysfunction in depression in a limited way, and some treatments may even worsen cognition in some patients. Moreover, there is a lack of alignment in the scientific field on the best way to assess cognitive dysfunction and whether this dimension is congruent with, or independent from, mood symptoms. There is also an opportunity in this domain to look beyond the classical definition of major depressive disorder and consider approaches involving neurocircuitry and precision medicine. The goal of the workshop is to bring together key stakeholders to explore ways of speeding improvement of the discovery, development, and regulatory path for new treatments addressing this aspect of depression.

Suggested Citation:"Appendix B: Workshop Agenda." 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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Meeting Objectives:

  • Examine opportunities to facilitate new target and validation strategies aimed at reinvigorating the development of treatments that address cognition, an undertreated aspect of depression.
  • Discuss how lessons from the translational aspects of cognitive dysfunction in other disorders could apply to depression.
  • Highlight gaps and limitations of current tools for assessing cognitive dysfunction in depression in clinical trials, and consider how improvements in cognition could relate to functional outcomes.
  • Explore potential regulatory challenges, such as recognition of cognitive dysfunction in depression as a public health need and opportunities for treatments.
8:30 a.m. Opening Remarks
 

THOMAS INSEL, Workshop Co-Chair

Director

National Institute of Mental Health

 

THOMAS LAUGHREN, Workshop Co-Chair

Director

Laughren Psychopharm Consulting, LLC

SESSION I: BACKGROUND AND OVERVIEW

Session Objectives: Provide an overview of the unmet medical need of cognitive dysfunction in depression. Discuss lessons learned from developing treatments for cognitive dysfunction in schizophrenia. Examine opportunities to facilitate new target and validation strategies aimed at reinvigorating the development of treatments that address cognition.

8:40 a.m. Opening Remarks
 

ANDREW NIERENBERG, Session Moderator

Thomas P. Hackett, M.D., Endowed Chair in Psychiatry

Massachusetts General Hospital

Suggested Citation:"Appendix B: Workshop Agenda." 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.
×
8:45 a.m. Cognitive Dysfunction in Depression: The Need for Discovery, Development, and Translation in This Domain (20 min talk + 10 min discussion)
 

BARBARA SAHAKIAN

Professor of Psychiatry

Cambridge University

9:15 a.m. Experimental Design and Approaches: Opportunities to Facilitate New Target and Validation Strategies for Cognitive Dysfunction in Depression (20 min talk + 10 min discussion)
 

CATHERINE HARMER

Professor of Cognitive Neuroscience

University of Oxford

9:45 a.m. Lessons Learned from Cognitive Dysfunction in Schizophrenia (20 min talk + 10 min discussion)
 

MICHAEL GREEN

Professor-in-Residence

Department of Psychiatry and Biobehavioral Sciences

Geffen School of Medicine, University of California, Los Angeles

10:15 a.m. BREAK

SESSION II: STATE OF THE SCIENCE FOR TREATING COGNITIVE DYSFUNCTION IN DEPRESSION

Session Objectives: Examine the current state of the science for treating cognitive dysfunction in depression, including what aspects of this dysfunction can be treated with medications, cognitive behavioral therapy, devices, and other treatment modalities. Identify promising future directions.

Suggested Citation:"Appendix B: Workshop Agenda." 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.
×
10:30 a.m. Opening Remarks
 

AMIT ETKIN, Session Moderator

Assistant Professor of Psychiatry and Behavioral Sciences

Stanford University

10:35 a.m. Effects of Non-Pharmacological Treatments on Cognition in Depression
 

DIEGO PIZZAGALLI

Professor of Psychiatry

Harvard Medical School

10:50 a.m. Effects of Pharmacological Treatments on Cognition in Depression
 

RICHARD KEEFE

Professor of Psychiatry and Behavioral Sciences

Duke University

11:05 a.m. Effects of Cognitive Remediation on Cognition in Depression
 

CHRISTOPHER BOWIE (by videoconference)

Clinical Psychologist and Associate Professor

Queen’s University

11:20 a.m. Discussion Among Panelists and Workshop Participants
12:00 p.m. LUNCH

SESSION III: DESIGN AND ASSESSMENT CHALLENGES

Session Objectives: Examine opportunities and challenges in studying and assessing treatments for cognitive dysfunction in depression, including combination therapies. Highlight gaps and limitations of current tools for diagnosing and evaluating depression in clinical trials, and consider how the indexes could be expanded to include indexes of cognitive functioning.

Suggested Citation:"Appendix B: Workshop Agenda." 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.
×

Discuss how improved cognition can be measured in short trials and the potential role of proxy measures. Consider acute versus residual treatment.

12:45 p.m. Opening Remarks
 

MADHUKAR TRIVEDI, Session Moderator

Betty Jo Hay Distinguished Chair in Mental Health

University of Texas Southwestern Medical Center

12:50 p.m. Design
 

MAURIZIO FAVA

Director, Clinical Research Program

Massachusetts General Hospital

1:05 p.m. Assessment
 

PHILIP HARVEY

Professor of Psychiatry and Behavioral Sciences

University of Miami Miller School of Medicine

1:20 p.m. Lifespan Issues
 

PATRICIA AREÁN

Professor of Psychiatry

University of California, San Francisco, School of Medicine

1:35 p.m. Discussion Among Panelists and Workshop Participants
2:15 p.m. BREAK

SESSION IV: REGULATORY CHALLENGES AND POTENTIAL SOLUTIONS

Session Objectives: Explore potential regulatory challenges, such as recognition of cognitive dysfunction in depression as a public health need and opportunities for treatments. Examine methods for evaluating cognitive dysfunction in depression. Discuss the evidentiary base that would be needed for approval of treatments for cognitive dysfunction in depression, including combination treatments.

Suggested Citation:"Appendix B: Workshop Agenda." 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.
×
2:30 p.m. Opening Remarks
 

THOMAS LAUGHREN, Session Moderator

Director

Laughren Psychopharm Consulting, LLC

2:35 p.m. Food and Drug Administration Perspective: Drugs
 

TIFFANY FARCHIONE

Acting Deputy Director

Division of Psychiatry Products

Food and Drug Administration

2:45 p.m. Food and Drug Administration Perspective: Devices
 

CARLOS PEÑA

Director, Division of Neurological and Physical Medicine Devices

Office of Device Evaluation

Center for Devices and Radiological Health

Food and Drug Administration

2:55 p.m. European Medicines Agency Perspective
 

MARIA ISAAC (by videoconference)

Senior Scientific Officer

European Medicines Agency

3:05 p.m. Addressing Regulatory Challenges
 

THOMAS LAUGHREN

Director

Laughren Psychopharm Consulting, LLC

3:20 p.m. Discussion Among Panelists and Workshop Participants
4:00 p.m. BREAK
Suggested Citation:"Appendix B: Workshop Agenda." 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.
×

SESSION V: MOVING FORWARD

Session Objectives: A panel will synthesize and discuss key highlights from the workshop presentations and discussions, including identifying concrete next steps for action and research.

4:15 p.m. Panel Discussion
 

ANDREW NIERENBERG

Thomas P. Hackett, M.D., Endowed Chair in Psychiatry

Massachusetts General Hospital

 

AMIT ETKIN

Assistant Professor of Psychiatry and Behavioral Sciences

Stanford University

 

MADHUKAR TRIVEDI

Betty Jo Hay Distinguished Chair in Mental Health

University of Texas Southwestern Medical Center

 

THOMAS LAUGHREN

Director

Laughren Psychopharm Consulting, LLC

4:40 p.m. Discussion Among Panelists and Workshop Participants
5:15 p.m. Final Comments
 

THOMAS INSEL, Workshop Co-Chair

Director

National Institute of Mental Health

 

THOMAS LAUGHREN, Workshop Co-Chair

Director

Laughren Psychopharm Consulting, LLC

5:30 p.m. ADJOURN WORKSHOP
Suggested Citation:"Appendix B: Workshop Agenda." 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:"Appendix B: Workshop Agenda." 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:"Appendix B: Workshop Agenda." 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 66
Suggested Citation:"Appendix B: Workshop Agenda." 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 67
Suggested Citation:"Appendix B: Workshop Agenda." 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 68
Suggested Citation:"Appendix B: Workshop Agenda." 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 69
Suggested Citation:"Appendix B: Workshop Agenda." 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 70
Suggested Citation:"Appendix B: Workshop Agenda." 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 71
Suggested Citation:"Appendix B: Workshop Agenda." 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 72
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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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