Rosemary Payne MSN Senior Supervisory Nurse Manager Clinical Center National Institute of Health Lawrence Park MD Medical Director Experimental Therapeutics amp Pathophysiology Branch ETPB ID: 605435
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Clinical Management of Treatment Resistant Depression
Rosemary Payne, M.S.N.Senior Supervisory Nurse ManagerClinical CenterNational Institute of HealthLawrence Park, M.D.Medical DirectorExperimental Therapeutics & Pathophysiology Branch (ETPB)National Institute of Mental HealthSlide2
OutlineNIH-CC Model of Care
Rosemary Payne, MSNMissionDimensions of PracticeNursing DemographicsResearch ParticipationTreatment of TRD Lawrence Park, MDDepression StatisticsTRDTreatment AlgorithmAlternative TreatmentsInvestigative TreatmentsSlide3
NIH-CC – Clinical Research Nurse (CRN) Model of Care
Clinical Nursing Research Leadership-Sr. Supervisory Nurse – Nurse ManagerTeam Leader – Clinical ManagerClinical Research Team-Protocol CoordinatorPrimary NurseAssociate NurseClinical Research Support-Clinical Research Nurse – per diemPatient Care TechnicianBehavioral Health TechnicianResearch Support Assistant – Unit ClerkSlide4
Mission/Vision of NIH-CC-CRN Team
MissionProvided 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.VisionThe 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.Slide5
The Art/Science of Clinical Research Nursing
Dimensions of PracticeSlide6
Clinical Research Nurse DemographicsEducation PreparationInpatient – 70% Bachelor of Science or higher
Outpatient – 88% Bachelor of Science or higherYears of Clinical Research Nurse ExperienceInpatient – 7 to 30 yearsOutpatient – 5 to 35 yearsMulti-cultural and inclusionarySpecialty and advance practiceSlide7
Research ParticipantIndividualized 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)Slide8
Research Subject DemographicsLocal – Maryland/DC/VirginiaNational geography
Ages 18-65, based on eligibilityMulticultural and diverseSlide9
AcknowledgementsJohn Gallin, MD – Clinical Center DirectorClare Hastings, PhD, Chief Nursing Officer
Barbara Jordan, PhD, Service Chief – NBHPRosemary Payne, MSN, Sr. Supervisory Nurse ManagerVictoria Liberty, BSN, Clinical ManagerRoger Brenholtz, MSN, Clinical ManagerBrenda Justement, MSN, Clinical Manager Slide10
Euthymic
Depressed
Next generation antidepressant
Lag of onset
:
10-14 weeks
Rapid onset
: Hours/day
Disruption to personal,
family, and social life
Occupational impairment
Risk of suicidal behavior
Depression: Adverse Effects
Problems 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, MDSlide11
Lessons from STAR*DTreatment AlgorithmsSlide12
Treatment Resistant Depression
Trivedi et al. (Am J Psychiatry, 2006); Rush et al. (NEJM, 2006)Slide13
STEP-BDStudy 1. Acute Phase BP Depression
Discontinuation rate34% both groupsRemission transient~15% both groupDurable recovery (8w)24% active27% placeboTEAS rate (switching)10% active11% placebo
From: Thase ME. STEP-BD and Bipolar Depression: What Have We Learned? Current Psychiatry Reports. 2007,9:497-503.Slide14
Augmentation Strategies
AugmentationEvidence Rating*
Added $ Monthlylithium 900 mg (to TCA)
A2T3 25 ug (to TCA)
A3mirtazapine 15 mg
A/B18
buspirone 40 mg
B
4
Wellbutrin SR 300 mg
B
42
Zyprexa 10 mg
B
172
Provigil 200 mg
B/C
110
nortriptyline 100 mg
C
2
pindolol 10 mg
C
2
lithium 900 mg (to SSRI)
C
2
T3 25 ug (to SSRI)
C
3
Effexor XR 150 mg
C
54
other atypicals
C
70-158
*Thase ME. CNS Spectrums 2004;9(11):808-821.(updated)
A= >1 RCTs
B= 1 RCT, plus c
C= Case series, anecdotal report, expert opinion
D= Anecdotal reports but experts have not endorsedSlide15
Electroconvulsive Therapy (ECT)
Oldest, most effective treatment for depressionMechanism of action unknownSeizure a necessary component of treatment General anesthesia requiredConfusion/memory loss potential side effects
Relapse a major issueSlide16
NeuroStar TMS
O’Reardon JP et al. Efficacy and Safety of TMS in the Acute Treatment of Major Depression: A Multisite RCT. Biol Psychiatry 2007:62:1208-16Slide17
Other Pharmacological StrategiesNew AntidepressantsVortioxetineLevomilnacipran
Vilazodone Atypical Antipsychotic AugmentationOlanzapine (UP, with fluoxetine)Quetiapine (UP adjunctive)Aripiprazole (UP adjunctive)Lurasidone (BP monotherapy/adjunctive)Slide18
Investigational TreatmentsKetamine (NMDA Antagonists)
Courtesy of Carlos Zarate Jr, MDSlide19
Rapid Antidepressant Effect
of Ketamine in Unmedicated Treatment Resistant MDD (n=18)
Zarate et al. Arch Gen Psychiatry 2006
-60
80
230
110
40
Day
1
Day
3
Day
2
Day
7
Time
*
**
**
***
***
***
80
230
110
40
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
Minutes
Courtesy of Carlos Zarate Jr, MDSlide20
Rapid Antidepressant Effect of Ketamine in
Treatment Resistant Bipolar (BP) Depression
Diazgranados et al. Arch Gen Psych 2010
Zarate et al. Biol Psych 2012
Replication BP study (n=15)
First BP Study of Ketamine (n=18)
MADRS
-60
80
230
110
40
Day
1
Day
3
Day
2
Day
7
Day
10
Day
14
***
***
***
***
***
***
*
-60
80
230
110
40
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
Minutes
Courtesy of Carlos Zarate Jr, MDSlide21
AcknowledgementNIMH/ETBP
StaffCarlos ZarateR. Machado-VieiraAllison NugentMaura FureyMin ParkMark NiciuErica RichardsJenny Vande VoortTyler
ArdElizabeth BallardWally DuncanNiall LallyImmaculata UkohRezvan AmeliNancy BrutscheIntramural Research Program, NIMHOffice of the Clinical Director, NIMH7SE, OP4, 7SW, NCF staffMEG/MRI/MRS/PET/SSCC CoresExtramural CollaborationsTodd 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 familiesSlide22
Thank You!Rosemary Payne, MSN
rosemary.payne@nih.gov Lawrence Park, MDlawrence.park@nih.govKalene Dehaut, MSWSocial Worker/Outreach RecruiterOffice of the Clinical Director, NIMHkalene.dehaut@nih.gov