bipolar mania: improving recognition, diagnostic accuracy...

Bipolar Mania: Improving Recognition, Diagnostic Accuracy, and Evidence-Based Treatment

A Free, One-Hour CME/CNE/CEP/NASW/CCMC/CPE On Demand ActivityRelease Date: October 28, 2009

12:00 p.m.–1:00 p.m. ET (live) • 3:00 p.m.–4:00 p.m. ET (taped re-air)Credit Expiration Date: October 28, 2010

On the Web: www.neuroscienceCME.com

FACULTY: Paul E. Keck, Jr., MD, Gary S. Sachs, MDMODERATOR: Roger S. McIntyre, MD, FRCPC

This continuing education activity is co-sponsored byIndiana University School of Medicine and by CME Outfitters, LLC.

Indiana University School of Medicine and CME Outfitters, LLC, gratefully acknowledge an educational grantfrom Bristol-Myers Squibb Company and Otsuka America Pharmaceutical, Inc., in support of this CE activity.

TV-064-102809-08FINALSYLLABUS AND COURSE GUIDE

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INFORMATION FOR PARTICIPANTSStatement of NeedA cardinal feature of bipolar disorder is the irregular recurrence of alternating abnormal mood states including depression, mania, and mixed states. Mania is frequently revealed retrospectively; patients are often not accurate in their recall of the severity and duration of symptoms, which can add further complexity to diagnosis. Symptoms of mania can include racing thoughts, pressured speech, irritability, lack of sleep, sexual preoccupation, excessive energy, and expansive mood, all of which can lead to problems at home, work, or school. Symptoms vary across individuals and disease course, and are often accompanied by comorbidities, all of which can pose diagnostic challenges. Delayed treatment has been shown to be associated in some cases with increased hospitalizations, greater risk of suicide, emergence of comorbid conditions, and global impairment. Once stabilized, maintenance treatment— pharmacotherapy, patient and family education, and psychosocial support—must be considered to prevent relapse, achieve better stability of mood, and improve function. In this interactive and evidence-based neuroscienceCME On Demand activity, the expert faculty will translate the evidence to improve outcomes in patients through better recognition, diagnosis, and treatment of bipolar mania.

Chengappa KNR, Goodwin GM. Characterizing barriers, challenges, and unmet needs in the management of bipolar disorder. Bipolar Disord 2005;7(Suppl 1):5-7.

Activity GoalTo improve competencies of clinicians managing patients with bipolar mania through better assessment, diagnosis, and treatment of the disorder.

Learning ObjectivesAt the end of this CE activity, participants should be able to:

• Integrate expert consensus, evidence base, structured interview, and assessment tools to accurately diagnose bipolar mania.

• Compare and contrast available agents for the acute management of bipolar mania in terms of efficacy and tolerability.

• Utilize guideline-based recommendations to develop individualized, multimodal treatment plans for the long-term manage-ment of patients with bipolar mania.

Target AudiencePhysicians, physician assistants, nurse practitioners, nurses, psychologists, social workers, certified case managers, pharmacists, and other healthcare professionals interested in mental health.

CREDIT INFORMATIONCME Credit (Physicians)Indiana University School of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. Indiana University School of Medicine designates this educational activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Note to Physician Assistants: AAPA accepts Category I credit from AOACCME, Prescribed credit from AAFP, and AMA Category I CME credit for the PRA from organizations accredited by ACCME.

CNE Credit (Nurses)CME Outfitters, LLC, is an approved provider of continuing nursing education by the New York State Nurses Association, an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation.

It has been assigned code 6WASUP-PRV-0673. 1.0 contact hours will be awarded upon successful completion.

Note to Nurse Practitioners: The content of this CNE activity pertains to Pharmacology.

CEP Credit (Psychologists)CME Outfitters is approved by the American Psychological Association to sponsor continuing education for psychologists. CME Outfitters maintains responsibility for this program and its content. (1.0 CE credits)

NASW Credit (Social Workers)This program was approved by the National Association of Social Workers (provider #886407722) for 1 continuing educationcontact hour.


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CCMC Credit (Certifi ed Case Managers)This program has been approved for 1 hour by the Commission for Case Manager Certification (CCMC).

CPE Credit (Pharmacists)CME Outfitters, LLC, is accredited by the Accreditation Council for Pharmacy Education as a provider of continuingpharmacy education. 1.0 contact hours (0.1 CEUs)Universal Program Number: 376-999-09-025-H01-P

Activity Type: knowledge-based

All other clinicians will either receive a CME Attendance Certificate or may choose any of the types of CE credit being offered.

Financial SupportIndiana University School of Medicine and CME Outfitters, LLC, gratefully acknowledge an educational grant from Bristol-Myers

Squibb Company and Otsuka America Pharmaceutical, Inc., in support of this CE activity.

CREDIT REQUIREMENTSSuccessful completion of this CE activity includes participating in the live or recorded activity, reviewing the course materials, and following the appropriate set of instructions below within 30 days of completion of the activity:

Option A: To complete your credit request form, activity evaluation, and post-test online, and print your certificate or statement of credit immediately (70% pass rate required), please visit www.neuroscienceCME.com and click on the Testing/Certification link under the Activities tab (requires free account activation).

—OR—

Option B:• Complete the credit request form and activity evaluation located in the back of this syllabus. Successfully complete the

post-test and record your responses on the credit request form.• Submit completed forms via FAX to 240.243.1033 or mail to:

CME Outfitters, LLC2400 Research Boulevard, Suite 425Rockville, MD 20850Attention: CE Forms Processor

• Participants will receive a certificate or statement of credit within 4–6 weeks following receipt of the credit request form and activity evaluation form.

There is no fee for participation in this activity. The estimated time for completion is 60 minutes.Questions? Please call 877.CME.PROS.

FACULTY BIOS & DISCLOSURESPaul E. Keck, Jr., MDDr. Keck is Craig and Frances Lindner Professor of Psychiatry and Neuroscience and Executive Vice Chairman of the Department of Psychiatry at the University of Cincinnati (UC) College of Medicine. He is also President-CEO of the Lindner Center of HOPE, a state-of-the-science, UC-affiliated comprehensive mental health center in Mason, Ohio. Dr. Keck has conducted extensive research in bipolar disorder and clinical psychopharmacology, supported by grants from the NIMH, NARSAD, the Stanley Foundation, and industry. He has been in the top 10 of the most cited scientists in the world, publishing in the fields of psychology and psychiatry since 1996.

A magna cum laude and Phi Beta Kappa graduate of Dartmouth College, Dr. Keck received his MD with honors from the Mount Sinai School of Medicine in New York City. He served his internship in Internal Medicine at the Beth Israel Medical Center in New York and completed his residency training in Psychiatry at Harvard Medical School and McLean Hospital, Belmont, Massachusetts. Dr. Keck remained on faculty at McLean and Harvard before joining the Department of Psychiatry at the University of Cincinnati in 1991.

Dr. Keck is the author of over 340 scientific papers in leading medical journals. He has also contributed over 160 reviews and chapters to major psychiatric textbooks. Dr. Keck is the editor or author of 6 scientific books and serves on the editorial boards of


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6 journals. He also serves on the American Psychiatric Association’s Workgroup to Develop Practice Guidelines for Treatment of Patients with Bipolar Disorders and currently serves on the APA Institute for Research and Education.

Dr. Keck is the recipient of numerous honors, including the Gerald Klerman Young Investigator Award from the National Depressive and Manic-Depressive Association (NDMDA); the Gerald Klerman Senior Investigator Award from the Depression & Bipolar Support Alliance (DBSA); the Exemplary Psychiatrist Award from the National Alliance of the Mentally Ill (NAMI); the Philip Isenberg Teaching Award from Harvard Medical School; the Nancy C A Roeske Certificate for medical student education from the American Psychiatric Association; Distinguished Fellow of the American Psychiatric Association; the Wyeth-Ayerst AADPRT Mentorship Award; two Communicator Awards for Continuing Medical Education; the Outstanding Physician Partner Award of the Postgraduate Institute for Medicine; and two Golden Apple Teaching Awards from the University of Cincinnati College of Medicine. He is listed as one of the Best Doctors in Cincinnati by Cincinnati Magazine; The Best Doctors in America, a directory of the top one percent of physicians in the United States as rated by their peers; and as one of the nation’s Best Mental Health Experts by Good Housekeeping Magazine.

Gary S. Sachs, MDDr. Sachs earned his medical degree at the University of Maryland School of Medicine. He interned in family practice and psychiatry at University of Maryland Hospital in Baltimore, was a resident in psychiatry and Chief Resident, Acute Psychiatry Service, at Massachusetts General Hospital in Boston.

Dr. Sachs was Principal Investigator of the NIMH Systematic Treatment Enhancement Program for bipolar disorder and is a Distinguished Fellow of the American Psychiatric Association. He chairs the scientific advisory committee of the National Alliance for the Mentally Ill and serves on the scientific advisory board of the Depression and Bipolar Support Alliance. Dr. Sachs is co-editor-in-chief of Clinical Approaches to Bipolar Disorder and serves on numerous editorial boards. Dr. Sachs has authored over 150 articles, abstracts, books, reviews, and book chapters. He currently focuses his work on clinical trial methodology, innovative approaches to clinical practice, and patient-centered research.

Roger S. McIntyre, MD, FRCPC (Moderator)Dr. McIntyre is currently an Associate Professor of Psychiatry and Pharmacology at the University of Toronto and Head of the Mood Disorders Psychopharmacology Unit at the University Health Network, Toronto, Canada.

Dr. McIntyre is involved in multiple research endeavors which primarily aim to characterize the association between mood disorders and medical comorbidity. This research involves elucidating metabolic adverse events associated with the use of psychotropic medications, the impact of medical comorbidity on the course of mood disorders, and the effect of glucose homeostasis on neurocognition.

Dr. McIntyre is extensively involved in medical education. He is a highly sought-after speaker at both national and international meetings. He has received several teaching awards from the University of Toronto Department of Psychiatry and has been a recipient of the joint Canadian Psychiatric Association (CPA)/Council of Psychiatric Continuing Education Award for the Most Outstanding Continuing Education Activity in Psychiatry in Canada.

Dr. McIntyre is a contributor to the CPA guidelines for the treatment of depressive disorders and the Canadian Network for Mood and Anxiety Treatments (CANMAT) guidelines for the management of bipolar disorder. Dr. McIntyre has published extensively in leading peer-reviewed journals and textbooks. Dr. McIntyre is also a reviewer for many journals including the American Journal of Psychiatry, Biological Psychiatry, Journal of Clinical Psychiatry, and The New England Journal of Medicine.

Dr. McIntyre completed his medical degree at Dalhousie University. He received his Psychiatry residency training and Fellowship in Psychiatric Pharmacology at the University of Toronto.

Amit Anand, MD (Content/Peer Reviewer)Professor Anand is Professor of Psychiatry and Radiology at Indiana University. Dr. Anand’s career for the past 20 years has been dedicated to the finding the cause of psychiatric illnesses, in particular the mood disorders—bipolar disorder and depression. Using a variety of biological and imaging techniques my aim is to discover the cause of these illnesses and how to develop new pharmacological and non-pharmacological treatments for these important illnesses.

Undergraduate: All India Institute of Medical Sciences

Fellowship: Yale University School of Medicine

Board Certifications/Certifications: Diplomate, American Board of Psychiatry and Neurology; Board Certified, American Board of Psychiatry and Neurology; Board Certified, Royal Australian and New Zealand College of Psychiatrists Current Academic Interests


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Teaching: Psychiatric interview techniques, formulation, state-of-the-art treatments for mood disorder and latest research in this area

Clinical: Pharmacological and non-pharmacological treatments of depression and bipolar disorder, novel therapeutics, increased understanding of illness

Disclosure DeclarationIt is the policy of Indiana University School of Medicine and CME Outfitters, LLC, to ensure independence, balance, objectivity, and scientific rigor and integrity in all its CE activities. Faculty must disclose to the participants any significant relationships with commercial companies whose products or devices may be mentioned in faculty presentations, or with the commercial supporter of this CE activity. CME Outfitters, LLC, has evaluated, identified, and attempted to resolve any potential conflicts of interest through a rigorous content validation procedure, use of evidence-based data/research, and a multidisciplinary peer review process. The following information is for participant information only. It is not assumed that these relationships will have a negative impact on the presentations.

Dr. Keck has disclosed that he serves as a consultant to GlaxoSmithKline, Organon Pharmaceuticals USA Inc., Pfizer, Inc., and Schering-Plough Corporation.

Dr. Sachs has disclosed that he receives grant support from GlaxoSmithKline, the National Institute of Mental Health, and Repligen Corporation. He serves as a consultant to, or on the advisory boards of, AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb Company, Cephalon, Inc., Concordant Rater Systems, Eli Lilly and Company, GlaxoSmithKline, Janssen, L.P., Memory Pharmaceuticals, Novartis Pharmaceuticals Corporation, Otsuka America Pharmaceutical, Inc., Pfizer Inc., Schering-Plough Corporation, Sepracor Inc., Repligen Corporation, Sanofi-aventis, and Wyeth Pharmaceuticals.

Dr. McIntyre has disclosed that he receives grants/research support from AstraZeneca Pharmaceuticals LP, Eli Lilly and Company, Janssen-Ortho, Inc, the National Alliance for Research on Schizophrenia and Depression (NARSAD), Shire Pharmaceuticals, and the Stanley Medical Research Institute. He serves on the advisory boards of AstraZeneca Pharmaceuticals LP, Biovail Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Eli Lilly and Company, The France Foundation, GlaxoSmithKline, H. Lundbeck A/S, Janssen-Ortho Inc., Organon Pharmaceuticals USA Inc., Pfizer Inc., Schering-Plough Corporation, Shire Pharmaceuticals, Solvay Pharmaceuticals, Inc., and Wyeth Pharmaceuticals. He serves on the speakers bureaus of AstraZeneca Pharmaceuticals LP, Biovail Pharmaceuticals, Inc., Eli Lilly and Company, H. Lundbeck A/S, Janssen-Ortho Inc., and Wyeth Pharmaceuticals.

Dr. Anand has disclosed that he has received honoraria from Pfizer Inc. as a consultant, and has received research grant from Eli Lilly and Company and AstraZeneca Pharmaceuticals LP as an independent investigator.

Unlabeled Use DisclosureFaculty of this CE activity may include discussions of products or devices that are not currently labeled for use by the FDA. The faculty have been informed of their responsibility to disclose to the audience if they will be discussing off-label or investigational uses (any uses not approved by the FDA) of products or devices.

Indiana University School of Medicine, CME Outfitters, LLC, the faculty, Bristol-Myers Squibb Company, and Otsuka America Pharmaceutical, Inc., do not endorse the use of any product outside of the FDA labeled indications. Medical professionals should not utilize the procedures, products, or diagnosis techniques discussed during this activity without evaluation of their patient for contraindications or dangers of use.

Activity SlidesThe slides that are presented in this activity are available for download and printout at the neuroscienceCME website:www.neuroscienceCME.com. Activity slides may also be obtained via fax or email by calling 877.CME.PROS.


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Abbreviation List

AA Alcoholics Anonymous

ADA American Diabetes Association

ADHD Attention-deficit hyperactivity disorder

AED Antiepileptic drug

APA American Psychiatric Association

ARI Aripiprazole

ASE Asenapine

BMI Body mass index

CBT Cognitive behavioral therapy

CBZ Carbamazepine

CLO Clozapine

CBZ-ER Carbamazepine extended-release

DSM Diagnostic and Statistical Manual of Mental Disorders

DVP Divalproex

FDA Food & Drug Administration

HAL Haloperidol

Li Lithium

LTG Lamotrigine

MINI Multi-International Neuropsychiatric Interview

ND Not determined

OLZ Olanzapine

PBO Placebo

QUE Quetiapine

RCT Random, controlled trial

RIS Risperidone

SCID Structured Clinical Interview for DSM-IV

STABLE STAndards for BipoLar Excellence

WFSBP World Federation of Societies of Biological Psychiatry

ZIP Ziprasidone


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DEDICATION

Dr. William P. Gruzenski, MDDistinguished Psychiatrist

August 22, 2009

CME Outfitters would like to dedicate today’s neuroscienceCME Live and On Demand activity to the memory of Dr. William Paul Gruzenski.

Dr. Gruzenski passed away this past August. He was a remarkable friend to everyone at CME Outfitters, sharing his education and experiences and discussing best practices and peer reviewed commentaries with other psychiatric leaders from across the nation. He will be remembered best as a distinguished psychiatrist.

Dr. Gruzenski was board-certified by the American Board of Psychiatry and Neurology and had held medical licenses in Pennsylvania, West Virginia, Texas, California, Idaho and Nevada. He also earned several medical education awards from the American Medical Association and the American Psychiatric Association. And every year, he completed over 250 total credit hours of continuing medical education in a multitude of medical specialties towards meeting his CME requirements.

Dr. Gruzenski’s distinguished career spanned more than 40 years. He was the Chief Medical Officer for 11 years at Clarks Summit State Hospital, beginning in 1997, and recently served as a Psychiatric Supervisor from 2008 until his retirement on August 01, 2009. He also treated patients in private practice in Pennsylvania and California. In Napa, Lake Tahoe and Reno, he held positions as Staff Psychiatrist. Likewise, in Houston, Reno, Blackfoot, and Stroudsburg, he held the position as Medical Director. Furthermore, he held numerous teaching positions, often guest spoke, and wrote weekly mental health articles. Dr. Gruzenski was always a professional to his staff and always demonstrated a positive impact on lives of his patients and those he served.

Sarah Dempsey, the Training & Staff Development Director at Clarks Summit State Hospital who worked closely with him shares, “No one could ever match Dr. G’s knowledge, wisdom, understanding, patience, laughter, and his love that he brought into my life and those around him. Bill was the one person who walked with me and never gave me anything but himself. We, his friends and colleagues, will all miss him dearly.”

Our thoughts and prayers are with his family, friends and colleagues.We thank you for sharing this wonderful man and distinguished psychiatrist with us.


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This CME/CE-certifiedactivity is supported byeducational grants from

Bristol-Myers SquibbCompany and Otsuka

America Pharmaceutical,Inc.

The course guide for thisactivity includes slides,disclosures of faculty

financial relationships,and biographical profiles.

For additional copies ofthese materials, please

visit neuroscienceCME.comor call 877.CME.PROS.

To receive CE credits for thisactivity, participants may

either complete the post-testand evaluation online at

neuroscienceCME.com/testor complete and submit botha Credit Request Form and an

Activity Evaluation Form,which are included in the

course materials.

This continuing educationactivity is co-sponsored by

Indiana UniversitySchool of Medicine andCME Outfitters, LLC.


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Moderator:Roger S. McIntyre, MD, FRCPC

Head, Mood DisordersPsychopharmacology Unit

University Health Network

Associate Professor of Psychiatryand Pharmacology

University of Toronto

Toronto, ON

Roger S. McIntyre, MD, FRCPCDisclosures

! Research/Grants: AstraZeneca Pharmaceuticals LP;Eli Lilly and Company; Janssen-Ortho, Inc.; the NationalAlliance for Research on Schizophrenia and Depression(NARSAD); Shire Pharmaceuticals; the Stanley MedicalResearch Institute

! Speakers Bureau: AstraZeneca Pharmaceuticals LP;Biovail Pharmaceuticals, Inc.; Eli Lilly and Company; H.Lundbeck A/S; Janssen-Ortho Inc.; Wyeth Pharmaceuticals

! Consultant: None

! Stockholder: None

! Other Financial Interest: None

! Advisory Board: AstraZeneca Pharmaceuticals LP;Biovail Pharmaceuticals, Inc.; Bristol-Myers SquibbCompany; Eli Lilly and Company; The France Foundation;GlaxoSmithKline; H. Lundbeck A/S; Janssen-Ortho Inc.;Organon Pharmaceuticals USA Inc.; Pfizer Inc.; Schering-Plough Corporation; Shire Pharmaceuticals; SolvayPharmaceuticals, Inc.; Wyeth Pharmaceuticals

Paul E. Keck, Jr., MD

President-CEO, Lindner Center of HOPE

Lindner Professor of Psychiatry &Neuroscience

University of Cincinnati College of Medicine

Cincinnati, OH

Please be sure to indicatethe media format utilized

(live broadcast, livewebcast, Internet archive,or rebroadcast/videotape)

and the date ofparticipation on the

forms provided.


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Gary S. Sachs, MD

Co-Director, Bipolar Clinic and ResearchProgram

Massachusetts General Hospital

Founder, Concordant Rater Systems

Associate Professor of Psychiatry

Harvard Medical School

Boston, MA

Gary S. Sachs, MDDisclosures

! Research/Grants: GlaxoSmithKline; the NationalInstitute of Mental Health; Repligen Corporation

! Speakers Bureau: None

! Consultant/Advisory Board: AstraZenecaPharmaceuticals LP; Bristol-Myers SquibbCompany; Cephalon, Inc.; Concordant RaterSystems; Eli Lilly and Company; GlaxoSmithKline;Janssen, L.P.; Memory Pharmaceuticals; NovartisPharmaceuticals Corporation; Otsuka AmericaPharmaceutical, Inc.; Pfizer Inc.; RepligenCorporation; Sanofi-aventis; Schering-PloughCorporation; Sepracor Inc.; Wyeth Pharmaceuticals

! Stockholder: None

! Other Financial Interest: None

The faculty have beeninformed of their

responsibility to discloseto the audience if they will

be discussing off-labelor investigational uses(any use not approvedby the FDA) of products

or devices.

Paul E. Keck, Jr., MDDisclosures

!Research/Grants: None

! Speakers Bureau: None

! Consultant: GlaxoSmithKline; OrganonPharmaceuticals USA Inc.; Pfizer, Inc.;Schering-Plough Corporation

! Stockholder: None

!Other Financial Interest: None

!Advisory Board: None


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LearningObjective 1

Integrate expert consensus,evidence base, structuredinterview, and assessmenttools to accurately diagnosebipolar mania

LearningObjective 2

Compare and contrastavailable agents for the acutemanagement of bipolar maniain terms of efficacy andtolerability

LearningObjective 3

Utilize guideline-basedrecommendations to developindividualized, multimodaltreatment plans for the long-term management of patientswith bipolar mania

Bipolar Mania:Improving Recognition,

Diagnostic Accuracy, andEvidence-Based Treatment

October 28, 2009Supported by an educational grant from

Bristol-Myers Squibb Company andOtsuka America Pharmaceutical, Inc.


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McIntyre RS, et al. Hum Psychopharmacol 2004;19:369-386.

BipolarDisorder

ImpulseControl

ADHD

PersonalityDisorders

Migraine

AnxietyDisorders

EatingDisorders

SubstanceAbuse

Obesity

Cardio-vascular

DiabetesMellitus

PainDisorders

ComorbiditiesThe Rule�Not the Exception

Sachs G. FOCUS 2007;5:3-13.

Strategies to ImproveDiagnosis

! Utilize family or other collateral informants

! Identify the most extreme episode of moodelevation

! Assess longitudinal factors

! Evaluate family history

! Review response prior to treatment

! Assess common conditions in differentialdiagnosis

! Assess common comorbidities

! Aim to estimate diagnostic confidence* AstraZeneca LP provided financial support for the STABLE Project

1. Goldman WE, et al. J Psychiatr Pract 2008;Suppl 2:18-30.2. Center for Quality Assessment and Improvement in Mental Health.

http://www.cqaimh.org/stable_measures.html.3. National Quality Forum. http://www.qualityforum.org.

Bipolar Performance MeasuresSTABLE* Project

! STAndards for BipoLar Excellence organized in 20051

! Develop and test evidence-based measures related toidentifying, assessing, managing, and coordinating carefor bipolar disorder2

! 5 STABLE measures endorsed by National QualityForum3

! Screening for mania/hypomania in patients diagnosed withdepression

! Assessment for risk of suicide! Assessment for substance use! Screening for hyperglycemia if atypical antipsychotic agents

are prescribed! Monitoring change in functioning in response to treatment

Sachs G. FOCUS 2007;5:3-13.

Factors that MakeDiagnosis Challenging

! Poor documentation of prior history

! Diagnostic criteria are vague andoveremphasize episode characteristics

! Mixed episodes

! Depression is a common chief complaint duringmanic episodes

! Current affective state influences perceptionsand reporting

! Absence of collateral informants

! Lack of validated biological marker

! Comorbid conditions are common


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Sachs GS. Acta Psychiatr Scand Suppl 2004;110:7-17.

Diagnostic ConfidenceThe Bipolarity Index

!Continuous measure of diagnosticconfidence

!Complements tools for DSMcategorical diagnosis!MINI and SCID

!Multidimensional clinical diagnosisof bipolar disorder!5 dimensions!Subject compared to classic

conception of bipolar disorder

Sachs GS. Acta Psychiatr Scand Suppl 2004;110:7-17.

5 Dimensions ofBipolarity Index

!Episodic characteristics

!Age of onset

!Course of illness/associated features

!Response to treatment

!Family history

Goldberg J, et al. J Clin Psychiatry 2007;68:1982-1983.

Individualizing TreatmentPrinciples

! Formulate clear impression about thedisease phenomenology and clinical state

! Employ a multi-modal treatment approach

! Distinguish comorbid disorders fromdifferential diagnoses

! Avoid treatments that worsen either phaseof the illness

! Assure adequate duration of medicationtrials prior to determining a treatment lacksefficacy

1. Spitzer RL, et al. Arch Gen Psychiatry 1992;49:624-629.2. Sheehan DV, et al. J Clin Psychiatry 1998;59 Suppl 20:22-33.

SCID1

StructuredClinical

Interviewfor DSM-IV

www.scid4.org

MINI2

Multi-International

NeuropsychiatricInterview

www.medical-outcomes.com/HTMLFiles/MINI/MINI.htm

Making the DiagnosisTools for DSM Categorical

Diagnosis


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Category A = superiority to PBO !2 RCTs; Category E = non-superiorityto PBO; Category F = efficacy or non-efficacy not proven

Grunze H, et al. World J Biol Psychiatry 2009;10:85-116.

Agents with Highest and LowestEvidence Category for

Acute Mania WFSBP Guidelines

! Category A! Lithium!Valproate!Carbamazepine!Haloperidol!Olanzapine!Risperidone!Quetiapine!Ziprasidone!Aripiprazole!Asenapine

! Category E or F!Gabapentin! Lamotrigine! Pregabalin! Tiagabine! Topiramate

Grunze H, et al. World J Biol Psychiatry 2004;5:120-135.

Initiating Pharmacotherapy forAcute Mania WFSBP Guidelines

First choice medication:

Choose monotherapy with a CE "A", RG "1" medication, considering:� Symptoms of mania (e.g., euphoric, mixed, psychotic) and severity� Previous experience and patients preference� Evidence for efficacy as maintenance treatment if appropriate� Modifying medical factors and specific safety profile� Route and ease of administration� Tolerability and efficacy in continuation therapy if indicated

Full response after 2 weeks:

Continue on medication until full remissionhas been achieved or beyond, if maintenancetreatment is indicated

Partial response after 2 weeks:

Continue on first choice medication,optimize dosage

No response after 2 weeks:

Switch to another first choice medication

In severe mania: Consider combination

Drugs@FDA. Available at http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA. Accessed October 22, 2009.

FDA-ApprovedBipolar Treatment Regimens

Generic Name Manic Mixed Maintenance Depression

Valproate X

Carbamazepine extendedrelease

X X

Lamotrigine X

Lithium X X X

Aripiprazole X X X

Ziprasidone X X

Risperidone X X

Asenapine X X

Quetiapine X X X X

Chlorpromazine X

Olanzapine X X X

Olanzapine/fluoxetinecombination

X

Goldberg J, et al. J Clin Psychiatry 2007;68:1982-1983.

Individualizing TreatmentPrinciples (cont.)

! Know which medications have or have notbeen studied in bipolar disorder

! Do not presume psychotropic �class effect�

! Consider the extent to which mood stabilizingagents exert relative antimanic vs.antidepressant effects

! Exercise caution when combining potentiallyredundant medications or ones that may exertundesirable pharmacokinetic orpharmacodynamic interactions


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Ketter TA (ed). Advances in the Treatment of Bipolar Disorders.Am Psychiatric Press, Inc. 2005:13.

* McIntyre RS, et al. Bipolar Disord 2009;11:673-686.

Acute Mania Monotherapy StudiesResponse Rates

1950mg/day

n = 134 n = 255 n = 223 n = 273 n = 304 n = 208 n = 268 n = 260 n = 1,265

1964mg/day

707mg/day

4.9mg/day

16mg/day

575mg/day

121mg/day

28mg/day

Mood Stabilizers Atypical Antipsychotics Placebo

n = 194

10-20mg/day

*

Areas of Concern with AgentsUsed to Treat Bipolar Disorder

! Lithium! Weight gain! Teratogenic! Thyroid dysfunction

! Antiepileptic drugs (AEDs)! Weight gain! Sedation! Teratogenic! Increased risk of suicidal ideation/suicide! Cognitive impact

! Atypical antipsychotics! Weight gain! High fasting glucose! Increase in prolactin! Sedation! Activation! Extrapyramidal symptoms

* p < .05 vs. no antipsychotic; N = 85,273Patients treated with an atypical antipsychotic medication should bemonitored for hyperglycemia

Olfson M, et al. Am J Psychiatry 2006;163:1821-1825.

Antipsychotics and Hyperlipidemia

*

* * * *

*

+ = number of adequately powered, randomized, controlled trials+/- = number of equivocal, randomized, controlled trialsND = not determined

Keck PE Jr. J Clin Psychiatry 2005;66(Suppl 3):5-11.Muzina DJ, Calabrese JR. Aust N Z J Psychiatry 2005;39:652-661.Gao K, et al. J Clin Psychiatry 2005;66:1376-1385.Citrome L. Int J Clin Pract 2009. [Epub ahead of print].

Bipolar DisorderSummary of Evidence from RCTs

DrugMania

MonotherapyMania

CombinationDepression Maintenance

Li ++ ++ + ++

DVP ++ ++ +/- +/-

CBZ ++ ND +/- +/-

LTG � ND ++ ++

OLZ ++ + ++ ++

RIS ++ + +/- ND

QUE ++ ++ ++ ++

ZIP ++ +/- -- ND

ARI ++ ++ -- ++

ASE ++ ++ ND ND


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Rouget BW, et al. J Affect Disord 2007;98:11-27.

Psychoeducation

! Can increase patients' and their families'knowledge of the disorder, availabletreatment options, and importance ofmedication compliance

! Can be delivered by a wide range of healthprofessionals trained in this approach

! Makes it possible to improve the course ofillness when used alone or as an adjunct! More studies based solely on psychoeducation,

rather than psychoeducation as part of a multi-component approach, are needed

ResourcesGuidelines and Measures

!WFSBP guidelines!http://www.wfsbp.org/treatment-

guidelines/bipolar-disorders.html

!STABLE performance measures!http://www.cqaimh.org/stable.html

ResourcesDiagnostic Scales

!Bipolarity Index!http://www.psycheducation.org/

depression/STEPBipolarityIndex.htm

!Structured Clinical Interview forDSM-IV!http://www.scid4.org

!Multi-InternationalNeuropsychiatric Interview!http://www.medical-outcomes.com/

HTMLFiles/MINI/MINI.htm

* More frequent assessments may be warranted based on clinical status

ADA/APA Consensus Conference. Diabetes Care 2004;27:596-601.

ADA/APA Consensus on AntipsychoticDrugs and Obesity and

Diabetes Monitoring Protocol*

Start4

wks8

wks12wks

Qtrly12

mos5

yrs

Personal/family Hx X X

Weight (BMI) X X X X X

Waist circumference X X

Blood pressure X X X

Fasting glucose X X X

Fasting lipid profile X X X X


17

Clinical Connections

!The use of diagnostic aids andmeasurement tools should be apart of routine practice

!Screen all mood disorder patientsfor bipolar disorder

!Selection and sequencing ofpatients for acute mania based onevidence

!Aspects of tolerability should bepertinent to treatment selection

Clinical Connections

!Psychoeducation improvesadherence to treatment anddiminishes relapse rate incombination with pharmacotherapy

!Education is important for patientsand family

www.neuroscienceCME.com

www.cmeoutfitters.com

ResourcesPatient Education

!Depression and Bipolar SupportAlliance!http://www.dbsalliance.org

!National Alliance on Mental Illness!http://www.nami.org

!National Institute of Mental Health!http://www.nimh.nih.gov/health/

publications/bipolar-disorder/complete-index.shtml


18

BibliographyAmerican Diabetes Association, American Psychiatric Association, American Association of Clinical Endocrinologists, North American Association for the Study of Obesity. Consensus development conference on antipsychotic drugs and obesity and diabetes. Diabetes Care 2004;27:596-601.

Bymaster FP, Calligaro DO, Falcone JF, et al. Radioreceptor binding profile of the atypical antipsychotic olanzapine. Neuropsychopharmacology 1996;14:87-96

Center for Quality Assessment and Improvement in Mental Health. Available at: http://www.cqaimh.org/stable_measures.html.

Citrome L. Asenapine for schizophrenia and bipolar disorder: a review of the efficacy and safety profile for this newly approved sublingually absorbed second-generation antipsychotic. Int J Clin Pract 2009;[Epub ahead of print].

Daniel DG, Zimbroff DL, Potkin SG, Reeves KR, Harrigan EP, Lakshminarayanan M. Ziprasidone 80 mg/day and 160 mg/day in the acute exacerbation of schizophrenia and schizoaffective disorder: a 6-week placebo-controlled trial. Ziprasidone study group. Neuropsychopharmacology 1999;20:491-505.

Drugs@FDA. Available at: http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA. Accessed October 22, 2009.

Farah A. Atypicality of atypical antipsychotics. Prim Care Companion J Clin Psychiatry 2005;7:268-274.

Farrelly N, et al. Presented at: American Psychiatric Association 2006 Annual Meeting; May 20-25, 2006; Toronto, ON, Canada. Poster NR 212.

Gao K, Gajwani P, Elhaj O, Calabrese JR. Typical and atypical antipsychotics in bipolar depression. J Clin Psychiatry 2005;66:1376-1385.

Goldberg JF. What constitutes evidence-based pharmacotherapy for bipolar disorder? Part 1: first-line treatments. J Clin Psychiatry 2007;68:1982-1983.

Goldman WE, Hermann RC, Jewell M, Brewster C. Development of evidence-based performance measures for bipolar disorder: overview of methodology. J Psychiatr Pract 2008;14(Suppl 2):18-30.

Grunze H, Kasper S, Goodwin G, Bowden C, Moller HJ; WFSBP Task Force on Treatment Guidelines for Bipolar Disorders. The World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for the biological treatment of bipolar disorders, part III: maintenance treatment. World J Biol Psychiatry 2004;5:120-135.

Keck PE Jr. The role of second-generation antipsychotic monotherapy in the rapid control of acute bipolar mania. J Clin Psychiatry 2005;66(Suppl 3):5-11.

Ketter TA, ed. Advances in the Treatment of Bipolar Disorders. American Psychiatric Press, Inc.; 2005: 13.

McIntyre RS, Konarski JZ, Yatham LN. Comorbidity in bipolar disorder: a framework for rational treatment selection. Hum Psychopharmacol 2004;19:369-386.

Muzina DJ, Calabrese JR. Maintenance therapies in bipolar disorder: focus on randomized controlled trials. Aust N Z J Psychiatry 2005;39:652-661.

National Quality Forum. Available at: http://www.qualityforum.org.

Olfson M, Marcus SC, Corey-Lisle P, Tuomari AV, Hines P, L’Italien GJ. Hyperlipidemia following treatment with antipsychotic medications. Am J Psychiatry 2006;163:1821-1825.

Package insert aripiprazole (2006). Available at: www.fda.gov. Accessed Aug. 14, 2007.

Rouget BW, Aubry JM. Efficacy of psychoeducational approaches on bipolar disorders: a review of the literature. J Affect Disord 2007;98:11-27.

Sachs GS. Bipolar disorder clinical synthesis: where does the evidence lead? FOCUS 2007;5:3-13.

Sachs GS. Strategies for improving treatment of bipolar disorder : integration of measurement and management. Acta Psychiatr Scand 2004;110(Suppl 422):7-17.

Shayegan DK, Stahl SM. Atypical antipsychotics: matching receptor profile to individual patient’s clinical profile. CNS Spectr 2004;9(Suppl 11):6-14.

Sheehan DV, Lecrubier Y, Sheehan KH, et al. The Mini-International Neuropsychiatric Interview (M.I.N.I.) : the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry 1998;59(Suppl 20):22-33.

Spitzer RL, Williams JB, Gibbon M, First MB. The Structured Clinical Interview for DSM-III-R (SCID). I : History, rationale, and description. Arch Gen Psychiatry 1992;49:624-629.


19

Supplemental Bibliography

Slide Title: Atypical Antipsychotic Neuropharmacology

1. Bymaster FP, Calligaro DO, Falcone JF, et al. Radioreceptor binding profile of the atypical antipsychotic olanzapine. Neuropsychopharmacology 1996;14:87-96.

2. Daniel DG, Zimbroff DL, Potkin SG, Reeves KR, Harrigan EP, Lakshminarayanan M. Ziprasidone 80 mg/day and 160 mg/day in the acute exacerbation of schizophrenia and schizoaffective disorder: a 6-week placebo-controlled trial. Ziprasidone study group. Neuropsychopharmacology 1999;20:491-505.

3. Farah A. Atypicality of atypical antipsychotics. Prim Care Companion J Clin Psychiatry 2005;7:268-274.

4. Package insert aripiprazole (2006). Available at: www.fda.gov. Accessed Aug. 14, 2007.

5. Shayegan DK, Stahl SM. Atypical antipsychotics: matching receptor profile to individual patient’s clinical profile. CNS Spectr 2004;9(Suppl 11):6-14.


20

Post-TestParticipants are required to complete the post-test to assess their achievement of the educational objectives for this activity. To obtain a certificate or statement of credit, you must complete the post-test and indicate your answers on the Post-Test Responses section found on the credit request form. You must complete both this post-test and the evaluation to receive credit. A score of 70% is required for credit.


1. STABLE measures endorsed by National Quality Forum include which of the following?

A. Assess for risk of suicide

B. Assess for substance use

C. Screen for bipolar mania/hypomania in patients diagnosed with depression

D. A and C

E. All of the above

2. Dimensions of Bipolarity Index include:

A. Age of onset

B. Course of illness

C. Family history

D. B and C

E. All of the above

3. True or False: Lithium is approved by the US FDA for the treatment of bipolar depression.

A. True

B. False

4. ADA/APA Consensus on Antipsychotic Drugs and Obesity and Diabetes recommends which of the following:

A. Thorough family history for cardiometabolic indicators at baseline

B. Blood pressure recorded after 8 weeks of treatment

C. Fasting lipids at baseline

D. A and C

E. All of the above

5. Factors that can make diagnosing bipolar disorder challenging include:

A. Depression is common chief complaint during manic episodes

B. Depression is not complaint during manic episodes

C. Current affective state of the patient

D. A and C

E. None of the above

6. The SCID, a diagnostic tool for bipolar disorder, stands for:

A. Structured Careteam Interview for Diagnosis

B. Structured Clinical Interview for DSM-IV

C. Short Cases In Diagnosis

D. Short Clinician Interviews in Diagnosis


7. True or False: Psychoeducation is not effective in bipolar disorder.

A. True

B. False

8. Which of the following agents has an odds ratio greater than 1.5 and is associated with significant increase in risk of incident hyperlipidemia?

A. Olanzapine, clozapine and aripiprazole

B. Clozapine, risperidone and aripiprazole

C. No agent was found to have an odds ratio greater than 1.5

D. Clozapine, olanzapine, risperidone

9. APA/ADA Consensus on Antipsychotic Drugs and Obesity and Diabetes requires weight monitoring at what intervals?

A. Baseline, 4 weeks, 8 weeks, 12 weeks and quarterly

B. Baseline and quarterly

C. Baseline, 4 weeks and quarterly

D. Baseline only


10. Which of the following agents is/are FDA-approved for manic episodes in bipolar disorder?

A. Olanzapine/fluoxetine combination

B. Lithium

C. Lamotrigine

D. Asenapine

E. B and D

Co-sponsored byTV-064-102809-08

FINAL

CE Credit Request Form

Bipolar Mania: Improving Recognition, Diagnostic Accuracy, and Evidence-Based TreatmentA CME/CNE/CEP/NASW/CCMC/CPE On Demand Activity

To receive CE credit, you must complete both this form and an evaluation form, and return the completed forms via mail to CME Outfitters, ATTN: CE Forms Processor, 2400 Research Boulevard, Suite 425, Rockville, MD 20850; or, FAX to 240.243.1033 for fastest service. Forms must be submitted within 30 days of completion of activity. A certificate or statement of credit will be mailed to you within 4–6 weeks of our receiving this form and the evaluation form.

To complete your credit request/activity evaluation online, and print your certificate or statement of credit immediately, please visitwww.neuroscienceCME.com and click on the Testing/Certification link under the Activities tab (requires free account activation).

PLEASE PRINT CLEARLY (Form must be filled out completely to process CE credit)

First Name, MI, Last Name: __________________________________________________________________________________________________

Specialty Area: ___________________________________________________________________________________________________________

I am a: q Physician q Physician Assistant q Nurse Practitioner q Nurse q Psychologist

q Social Worker q Certified Case Manager q Pharmacist q Other: __________________________

Degree: q MD q DO q PhD q NP q RN q PharmD q MSW q Other: ____________

I participated in a: q LIVE broadcast q LIVE webcast q LIVE audio feed q Internet archive q Rebroadcast/Videotape q Podcast

Participation Date: ________ / ________ / _______________

Complete Mailing Address: _________________________________________________________________________________________________

City: ___________________________________________________________________ State:_________________Zip:________________________

Business Phone: ______________________________________________________Fax: ________________________________________________

Email: ___________________________________________________________________________________________________________________

Type of CE credit requested: q CME/Physicians (max. 1.0 ________ ) q CNE/Nurses (1.0) q CEP/Psychologists (1.0) q NASW/Social Workers (1.0) q CCMC/Case Managers (1.0) q CPE/Pharmacists (1.0) q Others (1.0 CME Attendance Certificate)

Please see syllabus and course guide pages 2–3 for credit information and requirements.

How long did it take you to complete this activity? _____ hours________ minutes

Post-Test Responses (Enter letter of correct response; 70% score required for CE credit):

1. ________ 2. ________ 3. ________ 4. ________ 5. ________ 6. ________ 7. ________ 8. ________ 9. ________ 10. _______

How did you learn about this continuing education activity?

q Postcard/direct mail q Email q Internet q Colleague q Fax q Other: __________________

Please rate your interest in participating in future neuroscienceCME educational activities (1=highly interested, 5=uninterested): _____

What formats do you prefer for learning? (Please rank the top three; 1 = most preferred):

______ Symposium ______ Audioconference ______ Internet ______ CD-ROM

______ Journal ______ Satellite Broadcast ______ Monograph ______ Other: __________________________

As a result of my participation in this activity, I will commit to:

• Sharing information from this activity with staff and colleagues. q Yes q No

• Utilizing the assessment tools described in this activity to develop an individualized management/care plan for each of my patients. q Yes q No

• Analyzing overall improvement in patient management/carethrough use of the therapeutic options described in this activity. q Yes q No

Signature: _____________________________________________________________________________ Date:____________________________



FINAL

CE Activity Evaluation

Bipolar Mania: Improving Recognition, Diagnostic Accuracy, and Evidence-Based TreatmentA CME/CNE/CEP/NASW/CCMC/CPE On Demand Activity

To receive CE credit, you must complete both this form and a credit request form, and return the completed forms via mail to CME Outfitters, ATTN: CE Forms Processor, 2400 Research Boulevard, Suite 425, Rockville, MD 20850; or, FAX to 240.243.1033 for fastest service. Forms must be submitted within 30 days of completion of activity. A certificate or statement of credit will be mailed to you within 4–6 weeks of our receiving this form and the credit request form.

To complete your credit request/activity evaluation online, and print your certificate or statement of credit immediately, please visitwww.neuroscienceCME.com and click on the Testing/Certification link under the Activities tab (requires free account activation).

1. The content level was: q Too easy q About right q Too difficult Strongly Agree Strongly Disagree

2. Objectives were related to the overall purpose/goal of the activity (to improve competencies 5 4 3 2 1of clinicians managing patients with bipolar mania through better assessment, diagnosis,and treatment of the disorder).

3. The course met the stated objectives:• Integrate expert consensus, evidence base, structured interview, and assessment tools to 5 4 3 2 1

accurately diagnose bipolar mania. • Compare and contrast available agents for the acute management of bipolar mania in 5 4 3 2 1

terms of efficacy and tolerability. • Utilize guideline-based recommendations to develop individualized, multimodal treatment 5 4 3 2 1

plans for the long-term management of patients with bipolar mania. 4. The educational materials were useful. 5 4 3 2 1 5. The visual aids were useful and appropriate. 5 4 3 2 1 6. The overall activity was excellent. 5 4 3 2 1 7. The physical environment/format was conducive to learning. 5 4 3 2 1 8. The moderator was effective at facilitating the faculty discussion. 5 4 3 2 1 9. Rate the quality of the faculty member(s) listed below, from 5 (Excellent) to 1 (Poor):

Clinical Teaching Level of Speaker Content Relevance Strategies ExpertisePaul E. Keck, Jr., MD 5 4 3 2 1 5 4 3 2 1 5 4 3 2 1 5 4 3 2 1

10. Will you change the way you practice based on this activity? q Yes q No

If no, is it because you already practice this way? q Yes q No

If no, please explain: __________________________________________________________________________________________________________

11. Do you feel the activity was balanced and objective? q Yes q No

If no, please state reasons: _____________________________________________________________________________________________________

12. Do you feel the activity was free of commercial bias? q Yes q No

If no, did it negatively impact the educational value of this activity? q Yes q No

If yes, please state reasons: ____________________________________________________________________________________________________

__________________________________________________________________________________________________________________________

13. What was the most useful information you gained from this activity? _________________________________________________________________

__________________________________________________________________________________________________________________________

14. Suggested topics for future activities: ___________________________________________________________________________________________

__________________________________________________________________________________________________________________________

15. General comments/suggestions: _______________________________________________________________________________________________

__________________________________________________________________________________________________________________________

16. I participated in a: q LIVE broadcast q LIVE webcast q LIVE audio feed q Internet archive q Rebroadcast/Videotape q Podcast

17. Participation date: ________ / _________ / ____________________

18. I am a: q Physician q Physician Assistant q Nurse Practitioner q Nurse q Psychologist q Social Worker q Certified Case Manager q Pharmacist q Other: ______________________________

Thank you for your feedback. Your comments will be reviewed carefully and ultimately usedto guide the development of our future continuing education activities.



FINAL

Attendance Form for GroupsPlease complete and FAX to 240.243.1033

Activity Title and Faculty:Bipolar Mania: Improving Recognition, Diagnostic Accuracy, and Evidence-Based Treatmentwith Roger S. McIntyre, MD, FRCPC, Paul E. Keck, Jr., MD, and Gary S. Sachs, MD

Site/Institution Name: __________________________________________________________________________

Practice Setting: _______________________________________________________________________________

Address:______________________________________________________________________________________

City: _____________________________________________________ State: ________ ZIP: __________________

Site Coordinator: ________________________________ Phone: ________________________________________

Fax: __________________________________ Email: _________________________________________________

Completion Date: ___________ We participated in a: _________________________________________________

Attendee Name (please print) Please Circle Discipline

_________________________________ MD DO PA NP RN Pharm Psychol Other: __________

















Please FAX completed form to 240.243.1033 and use additional sheets as necessary.Questions? Call 877.CME.PROS. Thank you for participating in this continuing education activity!

q Community Mental Health q State Mental Health q Private Practice q Primary Care q Other:

q LIVE broadcast q LIVE webcast q LIVE audio feedq Internet archive q Rebroadcast/Videotape q Podcast


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