NIMH Update Christopher Sarampote NIMH Office of Training

NIMH Update Christopher Sarampote, NIMH Office of Training and Career Development Division of Translational Research NIMH 2017 AADCAP Annual Meeting Washington, DC

NIMH Extramural Scientific Divisions Translational (DTR) Neuroscience & Basic Behavioral (DNBBS) Pre-Clinical 2 AIDS/HIV (DAR) Psychopathology Tx Development Office of Research Disparities and Global Mental Health (ORDGMH) Services & Interventions (DSIR) Effectiveness Services

NIMH Transitions • Leadership ■ New Director: Josh Gordon, MD, Ph. D ■ New Deputy Director: Shelli Avenevoli, Ph. D • NIMH and HHS ■ NIMH looks forward to working with the new administration ■ NIMH contributed to NIH transition reports ■ Dr. Collins will continue as NIH Director for an indeterminate time 3

21 st Century Cures Act (Dec 2016) • Non-partisan national commitment to mental health research, prevention, treatment, and recovery • Key provisions for mental health treatment: ■ Appoints directors of NIMH, NIDA, NIAAA, to SAMHSA advisory councils ■ Encourages collaboration to ensure evidence-based practices ■ Strengthens existing mental and behavioral health care parity legislation ■ Includes broad provisions to assist for special populations • Key provisions for mental health research: ■ Encourages rigor and reproducibility; strengthens NIH’s ability to enforce data sharing ■ Requires Certificates of Confidentiality for clinical research ■ Exempts certain genomic data from Freedom of Information Act requests 4

21 st Century Cures Act of 2016 • $4. 8 Billion for NIH Innovative Research Initiatives Reprinted from Hudson, KL and Collins, FS (2017). The 21 st Century Cures Act: A View from the NIH. NEJM, 376: 111 -113. 5

NIH BRAIN Initiative • Oct 2016: NIH announced third round of grants ■ Over 100 new awards ■ 170 investigators working at 60 institutions ■ Totaling more than $70 m ■ Nearly doubles FY 2016 NIH investment in BRAIN • 6 21 st Century Cures Act authorizes funding for 10 more years

Adolescent Brain Cognitive Development (ABCD) Study 7 • • www. abcdstudy. org • Will recruit 10, 000 healthy children and follow into adulthood Multi-site, landmark study on brain development and child health led by NIDA, NIAAA, NCI

NIMH Budget Updates 8

Overview of Current NIMH Priorities • • • 9 Strategic Objectives Experimental Therapeutics Approach to Interventions RDo. C and Data-Driven Approaches Suicide Prevention Understanding Neural Circuits Computational Psychiatry

NIMH and Clinical Neuroscience To wrest from nature the secrets which have perplexed philosophers in all ages, to track their sources the cause of disease, to correlate the vast stores of knowledge, that they may be quickly available for prevention and cure of disease – these are our ambitions. - Sir William Osler 10

NIMH Research Priorities • Mission: To transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure • Strategic Objective 1: Define the mechanisms of complex behaviors • Strategic Objective 2: Chart mental illness trajectories to determine when, where, and how to intervene • Strategic Objective 3: Strive for prevention and cures • Strategic Objective 4: Strengthen the public health impact of NIMH-supported research 11

Experimental Therapeutics Approach to Interventions Intervention as tool to validate or engage the target 12 Target Engagement informs “go/”nogo” decision Clinical Trial value optimized regardless of clinical effect

Experimental Therapeutics Clinical Trials Funding Opportunity Announcements (FOAs) Clinical Trial Pipeline: Phase of Intervention Development First in Human Exploratory Experimental Therapeutics First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Devices for Psychiatric Disorders (U 01) Early Stage Testing of Pharmacologic or Devicebased Interventions for the Treatment of Mental Disorders (R 61/R 33, R 33) Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R 61/R 33, R 33) 13 Confirmatory Efficacy Trials of Non. Pharmacological Interventions for Mental Disorders (R 01) Effectiveness Trials for Treatment, Preventive, and Services Interventions Pilot Effectiveness Trials for Treatment, Preventive and Serivices Interventions (R 34) Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (R 01, Collaborative R 01) https: //www. nimh. nih. gov/funding/opportunities-announcements/clinical-trialsfoas/index. shtml

Research Domain Criteria (RDo. C) • Dimensional approach to psychopathology that integrates elements of biology and psychology ■ Template for psychopathology research (NOT a classification system) ■ Agnostic to diagnosis, but focused on narrowly defined impairments of psychiatric clinical importance 14

Research Domain Criteria (RDo. C) • • Over 40 grants funded under RDo. C FOAS since 2011 Resources ■ NIMH RDo. C webpage ■ RDo. C monthly “Office Hours” ■ RDo. C Webinar Series ■ RDo. C-influenced Courses 15

Suicide Prevention 16

Behavioral Neuroscience: Understanding Neural Circuitry Etiological Factors (genes, experience) • Molecular or Structural Pathology Circuit Dysfunction Neurofunctional Disability Understanding brain function and dysfunction ■ Characterize molecular identity, anatomy, and activity patterns in a cell-type specific manner • Monitor and manipulate circuits for improved function ■ Drive and inhibit circuits with precise behavioral effects. 17

Computational Psychiatry 18

Research Training and Career Development • • NIMH offers training grants across the career timeline Three ways NIMH provides training funds ■ Directly from NIH (individual awards: F, K) ■ From an academic institution with an NIH-supported training program (T 32) ■ From an administrative supplement to an existing NIH grant (diversity reentry, MD) 19

Specific Training Opportunities • F 30 NRSA Individual Predoctoral MD/Ph. D or other Dual-Doctoral Degree Fellowship • • Administrative Supplements for Physician Scientists • NIMH Mentoring Networks for Mental Health Research (R 25) 20 NIMH Research Education Programs Supporting Psychiatry Residents (R 25)

Career Development Program in Emergency Care Research (K 12) • Areas of interest: suicide prevention; management of psychiatric emergencies in ED settings; post-traumatic psychopathology risk detection and intervention; and mental health services in ED settings. • Recruitment of the second, and final, cohort of K 12 scholars will open later in 2017 ■ Indiana Emergency Care Research (Indiana EMCARE) Training Program ■ Indiana University School of Medicine ■ Program Directors: Jeffrey A. Kline, MD and Kurt Kroenke, MD ■ Oregon Emergency Care Research Multidisciplinary Training Program ■ Oregon Health & Science University ■ Program Directors: Craig D. Newgard, MD, MPH and Cynthia D. Morris, Ph. D, MPH ■ Vanderbilt Emergency Care Research Training Program • 21 ■ Vanderbilt University ■ Program Directors: Alan B. Storrow, MD and Thomas J. Wang, MD NIMH Contact: Lauren Hill, Ph. D

NIH Loan Repayment Program • • Repay up to $35 K annually of a researcher’s qualified educational debt Renewable https: //www. lrp. nih. gov 22

www. nimh. nih. gov Research = Hope 23