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Clinical Management of Treatment Resistant Depression Rosemary Payne, M.S.N. Senior Supervisory Nurse Manager Clinical Center National Institute of Health.

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Presentation on theme: "Clinical Management of Treatment Resistant Depression Rosemary Payne, M.S.N. Senior Supervisory Nurse Manager Clinical Center National Institute of Health."— Presentation transcript:

1 Clinical Management of Treatment Resistant Depression Rosemary Payne, M.S.N. Senior Supervisory Nurse Manager Clinical Center National Institute of Health Lawrence Park, M.D. Medical Director Experimental Therapeutics & Pathophysiology Branch (ETPB) National Institute of Mental Health

2 Outline NIH-CC Model of Care Rosemary Payne, MSN – Mission – Dimensions of Practice – Nursing Demographics – Research Participation Treatment of TRD Lawrence Park, MD – Depression Statistics – TRD – Treatment Algorithm – Alternative Treatments – Investigative Treatments

3 NIH-CC – Clinical Research Nurse (CRN) Model of Care Clinical Nursing Research Leadership- – Sr. Supervisory Nurse – Nurse Manager – Team Leader – Clinical Manager Clinical Research Team- – Protocol Coordinator – Primary Nurse – Associate Nurse Clinical Research Support- – Clinical Research Nurse – per diem – Patient Care Technician – Behavioral Health Technician – Research Support Assistant – Unit Clerk

4 Mission/Vision of NIH-CC-CRN Team Mission Provided clinical care for patients participating in clinical research studies conducted by investigators within the Intramural Research Program at the National Institutes of Health. As integral research team members, we provide support for the design, coordination, implementation and dissemination of clinical research by NIH investigators, with a focus on patient safety, continuity of care and informed participation. We are also committed to supporting the NIH effort to train the next generation of clinical researchers and provide national leadership for the clinical research enterprise. Vision The Clinical Center leads the Nation in developing a specialty practice model for Clinical Research Nursing. This model will define the roles and contributions of nurses who practice within the clinical research enterprise, as they provide care to research participants and support accurate, reliable and ethical study implementation. We will also develop and disseminate practice documents, standards and management tools for implementing clinical research nursing across a wide continuum of practice settings.

5 The Art/Science of Clinical Research Nursing Dimensions of Practice Clinical Practice Care Coordination and Continuity Contribution to the Science Human Subjects Protection Study Management

6 Clinical Research Nurse Demographics Education Preparation – Inpatient – 70% Bachelor of Science or higher – Outpatient – 88% Bachelor of Science or higher Years of Clinical Research Nurse Experience – Inpatient – 7 to 30 years – Outpatient – 5 to 35 years Multi-cultural and inclusionary Specialty and advance practice

7 Research Participant Individualized research and nursing plan of care. Interdisciplinary team approach to research, stabilization and reintegration. Collaboration and/or referral to community providers and supports. Structured community outings and access to other ancillary support services (social workers, recreational/rehabilitation therapists, nutritionists, pharmacists and chaplains)

8 Research Subject Demographics Local – Maryland/DC/Virginia National geography Ages 18-65, based on eligibility Multicultural and diverse

9 Acknowledgements John Gallin, MD – Clinical Center Director Clare Hastings, PhD, Chief Nursing Officer Barbara Jordan, PhD, Service Chief – NBHP Rosemary Payne, MSN, Sr. Supervisory Nurse Manager Victoria Liberty, BSN, Clinical Manager Roger Brenholtz, MSN, Clinical Manager Brenda Justement, MSN, Clinical Manager

10 Euthymic Depressed Next generation antidepressant Lag of onset: weeks Rapid onset: Hours/day Disruption to personal, family, and social life Occupational impairment Risk of suicidal behavior Depression: Adverse EffectsProblems with Current Antidepressants: Low remission rates Questionable efficacy in bipolar depression Lag of onset of antidepressant effects Standard antidepressant (Monoaminergic) Major Depressive Episode Initiate Treatment Depression: The Need for Improved Treatments Courtesy of Carlos Zarate Jr, MD

11 Lessons from STAR*D Treatment Algorithms

12 Treatment Resistant Depression Trivedi et al. (Am J Psychiatry, 2006); Rush et al. (NEJM, 2006)

13 STEP-BD Study 1. Acute Phase BP Depression Discontinuation rate – 34% both groups Remission transient ~15% both group Durable recovery (8w) – 24% active – 27% placebo TEAS rate (switching) – 10% active – 11% placebo From: Thase ME. STEP-BD and Bipolar Depression: What Have We Learned? Current Psychiatry Reports. 2007,9:

14 Augmentation Strategies AugmentationEvidence Rating* Added $ Monthly lithium 900 mg (to TCA)A2 T3 25 ug (to TCA)A3 mirtazapine 15 mgA/B18 buspirone 40 mgB4 Wellbutrin SR 300 mgB42 Zyprexa 10 mgB172 Provigil 200 mgB/C110 nortriptyline 100 mgC2 pindolol 10 mgC2 lithium 900 mg (to SSRI)C2 T3 25 ug (to SSRI)C3 Effexor XR 150 mgC54 other atypicalsC *Thase ME. CNS Spectrums 2004;9(11): (updated) A= >1 RCTs B= 1 RCT, plus c C= Case series, anecdotal report, expert opinion D= Anecdotal reports but experts have not endorsed

15 Electroconvulsive Therapy (ECT) Oldest, most effective treatment for depression Mechanism of action unknown Seizure a necessary component of treatment General anesthesia required Confusion/memory loss potential side effects Relapse a major issue

16 NeuroStar TMS O’Reardon JP et al. Efficacy and Safety of TMS in the Acute Treatment of Major Depression: A Multisite RCT. Biol Psychiatry 2007:62:

17 Other Pharmacological Strategies New Antidepressants – Vortioxetine – Levomilnacipran – Vilazodone Atypical Antipsychotic Augmentation – Olanzapine (UP, with fluoxetine) – Quetiapine (UP adjunctive) – Aripiprazole (UP adjunctive) – Lurasidone (BP monotherapy/adjunctive)

18 Investigational Treatments Ketamine (NMDA Antagonists) Courtesy of Carlos Zarate Jr, MD

19 Rapid Antidepressant Effect of Ketamine in Unmedicated Treatment Resistant MDD (n=18) Zarate et al. Arch Gen Psychiatry Day 1 Day 3 Day 2 Day 7 Time * ** *** Day 3 Day 2 Day 7 8 Weeks 13% 71% 53% 58% 56% 35% 53% 62-65% 35% Response: 50% decrease in HAMD HAMD Following a Single Ketamine Infusion Hamilton Depression Rating Scale (HAMD) % Participants Responding Monoaminergic Antidepressant Day 1 ***p<0.001, **p<0.01, *p<0.05 Minutes Courtesy of Carlos Zarate Jr, MD

20 Rapid Antidepressant Effect of Ketamine in Treatment Resistant Bipolar (BP) Depression Diazgranados et al. Arch Gen Psych 2010Zarate et al. Biol Psych 2012 Replication BP study (n=15)First BP Study of Ketamine (n=18) MADRS Day 1 Day 3 Day 2 Day 7 Day 10 Day 14 *** * Day 1 Day 3 Day 2 Day 7 Day 10 Day 14 *** Time Ketamine Placebo ***p<0.001, **p<0.01, *p<0.05 Minutes Courtesy of Carlos Zarate Jr, MD

21 Acknowledgement NIMH/ETBP Staff Carlos Zarate R. Machado-Vieira Allison Nugent Maura Furey Min Park Mark Niciu Erica Richards Jenny Vande Voort Tyler Ard Elizabeth Ballard Wally Duncan Niall Lally Immaculata Ukoh Rezvan Ameli Nancy Brutsche Intramural Research Program, NIMH Office of the Clinical Director, NIMH 7SE, OP4, 7SW, NCF staff MEG/MRI/MRS/PET/SSCC Cores Extramural Collaborations Todd Gould, Robert Schwartz (MD Psych Rsrch) Vistagen Therapeutics Rima Kaddurah-Daouk (Duke University) Gustavo Turecki (McGill University) Per Svenningsson (Karolinska Institutet) Paul Greengard (Rockefeller University) Brian Roth (University of North Carolina) Michael Perlis,Philip Gehrman,David Dinges (UPenn) RAPID Fast-Fail Trials Research Subjects and their families

22 Thank You! Rosemary Payne, MSN Lawrence Park, MD Kalene Dehaut, MSW Social Worker/Outreach Recruiter Office of the Clinical Director, NIMH


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