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Sponsored by The France Foundation. Supported by an educational grant from Sunovion.

Practical Strategies for the Treatment of Patients with Schizophrenia Leslie Citrome, MD, MPH Adjunct Professor of Psychiatry & Behavioral Sciences, New York Medical College, Valhalla, NY. Sponsored by The France Foundation. Supported by an educational grant from Sunovion.

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Sponsored by The France Foundation. Supported by an educational grant from Sunovion.

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  1. Practical Strategies for the Treatment of Patients with SchizophreniaLeslie Citrome, MD, MPHAdjunct Professor of Psychiatry & Behavioral Sciences, New York Medical College, Valhalla, NY Sponsored by The France Foundation.Supported by an educational grant from Sunovion.

  2. Faculty Disclosure It is the policy of The France Foundation to ensure balance, independence, objectivity, and scientific rigor in all its sponsored educational activities. All faculty, activity planners, content reviewers, and staff participating in this activity will disclose to the participants any significant financial interest or other relationship with manufacturer(s) of any commercial product(s)/device(s) and/or provider(s) of commercial services included in this educational activity. The intent of this disclosure is not to prevent a person with a relevant financial or other relationship from participating in the activity, but rather to provide participants with information on which they can base their own judgments. The France Foundation has identified and resolved any and all conflicts of interest prior to the release of this activity.

  3. DisclosureLeslie Citrome, MD, MPH Leslie Citrome, is a consultant for, has received honoraria from, or has conducted clinical research supported by the following: Abbott, AstraZeneca*, Avanir, Azur, Barr, Bristol-Myers Squibb*, Eli Lilly*, Forest, GlaxoSmithKline, Janssen*, Jazz, Merck*, Novartis*, Noven*, Pfizer*, Shire*, Sunovion*, Valeant*, and Vanda. * Denotes a relationship in effect anytime during the past 12 months

  4. Learning Objectives • Recognize criteria for remission and recovery in patients with schizophrenia. Evaluate patients for the potential to achieve these outcomes and implement strategies directed towards these goals • Recognize how clinical practice guidelines relate to the individualized treatment of patients with schizophrenia • Integrate strategies that will help to improve the effective use of medications by patients with schizophrenia

  5. Please take pretest now

  6. Poor attention Conceptual disorganization Difficulty in abstract thinking Disorientation Suspiciousness/paranoia Grandiosity/Delusions Unusual thought content Blunted affect Emotional withdrawal Active social avoidance Lack of spontaneity Poor rapport Schizophrenia – A Set of Symptoms Positive Symptoms Negative Symptoms “Disorganized” Symptoms

  7. Clinical and Pathophysiological Course of Schizophrenia Lieberman JA, et al. Biol Psychiatry. 2001;50(11):884-897.

  8. What is Response? Speed? Magnitude? Proportion responding? Effect in refractory patients?

  9. Measuring Efficacy - Decrease in PANSS Lieberman JA, et al. N Engl J Med. 2005;353(12):1209-1223.

  10. Decrease in PANSS Factors Heresco-Levy U, et al. Biological Psychiatry. 2004;55:165-171.

  11. Arbitrary Categorical Changes in PANSS Response defined as at least a 30% decrease from the baseline PANSS to the last observation Daniel DG, et al. Neuropsychopharmacology.1999;20:491-505.

  12. Functionality Distribution of patients achieving ≥ 1 change in Personal and Social Performance (PSP) Scale category at end point. Intent-to-treat population; PSP scale scores at end point for individual patients to show a clinically relevant change in personal and social functioning as represented by improvement of ≥ 1 category (classified as one 10-point interval); PSP = Personal and Social Performance Scale. Kane J, et al. Schizophr Res. 2007;90:147-161.

  13. What is remission and recovery in patients with schizophrenia?

  14. Response vs Remission Andreasen N, et al. Am J Psychiatry. 2005;162:441-449.

  15. Remission Definitions Andreasen N, et al. Am J Psychiatry. 2005;162:441-449.

  16. Proposed Criteria for Remission Andreasen N, et al. Am J Psychiatry. 2005;162:441-449.

  17. Recovery SAMHSA ‘‘Fundamental Components of Recovery’’ Consumer self-direction Individualized and person-centered treatment Empowerment A holistic treatment focus A nonlinear perspective of change Treatment focused on strengths instead of deficits The inclusion of peer support in treatment Respect for consumers and consumer self-respect Consumer acceptance of personal responsibility Hope in recovery Davidson’s Nine Common Elements of Recovery • Renewing hope and commitment • Redefining self • Incorporating illness into life as a whole • Involvement in meaningful activities • Overcoming stigma • Assuming control • Becoming empowered and exercising citizenship • Managing symptoms • Finding social support Peebles S, et al. Psych Clin N Am. 2007;30:567-583.

  18. Treatment Effectiveness Tolerability and Safety Does Rx cause SE? Efficacy Does Rx reduce Sx? Treatment Effectiveness Combines all measures Adherence/ Persistence Will Pt take Rx? Lieberman JA, et al. N Engl J Med. 2005;353(12):1209-1223. Lehman AF, et al. Am J Psychiatry. 2004;161(2 suppl):1-56. Swartz MS, et al. Schizophr Bull. 2003;29(1):33-43.

  19. CATIE Primary Outcome Measure:All-Cause Treatment Discontinuation Efficacy Tolerability All-Cause Discontinuation Patient Input Clinician Input

  20. EffectivenessTime to Any-Cause Discontinuation CATIE Clozapine Pathway Results McEvoy JP, et al. Am J Psychiatry.2006;163:600-610.

  21. EffectivenessAny-Cause Discontinuation: NNT CATIE Clozapine Pathway NNT 3 NNT 4 McEvoy JP et al. Am J Psychiatry.2006;163:600-610; Citrome L. Psychiatry MMC. 2007;4(10):23-29; Citrome L and Stroup TS. Int J Clin Pract.2006;60:933-940.

  22. What else do I need to know about recovery?

  23. Hierarchies of Outcome: Recovery is at Top Recovery Remission Stabilization

  24. Criteria for Recovery? • Symptom remission • Vocational functioning • Independent living • Peer relationships • Duration ≥ 2 years Is recovery best viewed as an outcome or a process? Liberman P, et al. Int Rev Psychiatry. 2002;14:256-272. Liberman P, Kopelowicz. Psychiatr Serv. 2005;56:735-742.

  25. Recovery – A Matter of Perspective • Recovery from Illness • Cure of illness, absence of illness versus • Recovery in Illness: being in recovery • Process of managing illness more effectively • Having a meaningful life in the community • Moving ahead with one’s life despite illness • Davidson L, et al. Schizophr Bull. 2008;34:5-8.

  26. Process of Recovery The Person Play The Illness The Person Friends Work The Person Family The Illness The Illness

  27. Factors Associated with the Potential for Positive Clinical and Functional Outcomes • Short duration of untreated psychosis • Good early response to antipsychotic treatment • Collaborative therapeutic alliance • Supportive family/caregivers • Access to comprehensive, coordinated, and continuous treatment • Opportunities to engage in functional activities and receive specialized interventions • Absence of substance abuse

  28. What about cognition in patients with schizophrenia?

  29. Cognitive Deficits Are the Bridge Between Brain Functioning and Functional Impairments in Day-to-Day Life • Cognitive deficits are a frequent and robust feature of the illness • Cognitive deficits are present at illness onset and persist throughout the illness • Cognitive deficits directly contribute to poor functional outcome in schizophrenia

  30. Normative Data Compared to a Schizophrenia Sample on the RBANS Neuropsychological Test Schizophrenia (n = 575) Normal controls (n = 540) 35 from standardization sample 30 25.0% 25.0% 25 22.8% 22.6% 20.6% % of Cases 20 16.5% 16.0% 16.0% 15 10 7.9% 7.2% 7.0% 7.0% 0.4% 0.4% 5 2.2% 0.4% 1.6% 1.6% 0% 0% 0% 0% 0 < 50-50 51-60 61-70 71-80 81-90 91-100 101-110 111-120 121-130 131-140 140+ Total Scale Score RBANS: Repeatable Battery for Assessment of Neuropsychological Status Wilk CM, et al. Schizophr Res. 2004;70(2-3):175-186.

  31. Components of Psychosocial Rehabilitation • Outcomes • Functional • Subjective • Motivational Aspects • External • Intrinsic • Social Cognition • Emotion processing • Social perception • Attributional bias • Theory of mind • Neurocognition • Attention • Processing • Memory • Reasoning • Verbal learning • Visual learning Kurzban S, et al. Curr Psychiatry Rep. 2010;12:345-355.

  32. Cognitive Remediation • Behavioral treatments that specifically target: • Memory • Attention • Executive functioning • Reasoning • Restorative cognitive techniques – drill and practice • Paper & pencil tasks • Computerized training software • COGPACK, Posit Science Brain Fitness, etc. • Individual • Groups • Compensatory cognitive training – promote adaptive behavior • Enhance daily functioning • School, work, social interactions, independent living • Enhance skills pertinent to recovery goals Medalia A, Choi J. Neuropsychol Rev. 2009;19:353-364.

  33. Work and Schizophrenia ~20% employed Barriers • Cognitive impairments • Psychiatric symptoms • Episodes of illness • Stigma from employers • Internalized stigma/low self-confidence • Fear of losing disability benefits 80% Unemployed 55–70% identify employment as a goal McGurk S, et al. Schizophr Bull. 2009;35:319-335. Kurzban S, et al. Curr Psychiatry Rep. 2010;12:345-355.

  34. Vocational Rehabilitation • Skills training • Sheltered workshops • Transitional employment • Supported employment • Vocational rehabilitation + cognitive remediation → best results • Employment = • Increased self esteem • Reduction in symptoms and hospitalizations • Enhanced social functioning • Improvement in overall quality of life McGurk S, et al. Schizophr Bull. 2009;35:319-335. Kurzban S, et al. Curr Psychiatry Rep. 2010;12:345-355.

  35. Supported Employment Basic Principles Zero exclusion; eligibility based on consumer choice Focus on competitive jobs in integrated community settings Rapid job search Respect for consumers’ preferences in terms of the nature of the job and types of support services Ongoing job support Close integration with a psychosocial rehabilitation team approach Benefits counseling (disability benefits, social security, medical insurance) McGurk S, et al. Schizophr Bull. 2009;35:319-335.

  36. Optimizing Employment OutcomesVocational Rehabilitation (VR) + Cognitive Remediation (CR) VR 45 VR + CR * 3000 40 2500 35 ** 30 2000 25 * Wages Earned Weeks Worked 1500 20 15 1000 10 500 5 0 0 Competitive Community Work Hospital-based Internship Competitive Community Work Hospital-based Internship Total Total * P < 0.05; ** P < 0.01 VR + CR: Greater improvements in verbal learning, memory, executive functioning vs VR only McGurk S, et al. Schizophr Bull. 2009;35:319-335. Cognitive remediation with COGPACK training software

  37. What can guidelines tell us?

  38. Management of Schizophrenia • Patient-focused therapeutic alliance • Individualized approach • Reduce or eliminate symptoms • Optimize quality of life • Assist patients in attaining personal life goals (work, housing, relationships) • Guidelines and algorithms provide a framework for decision making

  39. Guideline/Algorithm Recommendations FGA: first-generation antipsychotic SGA: second-generation (atypical) antipsychotic C: Clozapine C+: Clozapine augmentation CF: Clozapine failure Practice Guideline for the Treatment of Patients with Schizophrenia. 2nd Edition. APA. 2004. Moore T, et al. J Clin Psychiatry. 2007;68:1751-1762. Kreyenbuhl J, et al. Schizophr Bull. 2010;36:94-103.

  40. PORT Psychosocial TreatmentPatient Outcomes Research Team Dixon L, et al. Schizophr Bull. 2010;36:48-70.

  41. What is it that we actually do?

  42. Survey of APA Practice Research Network: Schizophrenia Treatments West J, et al. Psych Services. 2005;56:283-291.

  43. Real-World Antipsychotic Treatment Practices • Second-generation antipsychotics are used in over 70% of individuals with schizophrenia (use may be higher in first-episode patients) • Rate of clozapine use is much lower than the incidence of treatment-resistant schizophrenia • Antipsychotic polypharmacy • ~10 to 30% of individuals with schizophrenia • FGA + SGA most common combinations • Use of adjunctive medications • Baseline data from CATIE • Antidepressants (38%), anxiolytics (22%), sedative hypnotics (19%), lithium (4%), other mood stabilizers (15%) • Dosage of antipsychotic medications within therapeutic range 64 to 83% of the time during inpatient treatment Moore T, et al. Psychiatr Clin N Am. 2007;30:401-416.

  44. What do we know about efficacy and tolerability of antipsychotic medication?

  45. Meta-Analyses Demonstrate the Heterogeneity for Antipsychotic Response “All antipsychotics are equal, but some are more equal than others” - Volavka J, Citrome L. J Clin Psychiatry. 2009;70:429-430. SGA versus FGA Amisulpride Aripiprazole Clozapine Olanzapine Quetiapine Risperidone Sertindole Ziprasidone Zotepine Leucht S, et al. Lancet. 2009;373(9657):31-41.

  46. Meta-Analyses Demonstrate the Heterogeneity for Antipsychotic Response “All antipsychotics are equal, but some are more equal than others” - Volavka J, Citrome L. J Clin Psychiatry. 2009;70:429-430. SGA versus SGA Advantages for: Clozapine Olanzapine Risperidone Leucht S, et al. Am J Psychiatry. 2008;166(2):152-163.

  47. Antipsychotics – Heterogeneity for TolerabilityEPS, Prolactin, Weight, Glucose/Lipids, Sedation, Hypotension Volavka J, Citrome L. Expert Opin Pharmacother. 2009;10(12):1917-1928.

  48. CATIE – Reasons for Discontinuation N=1432 WEIGHT GAIN - METABOLIC EFFECTS EXTRAPYRAMIDAL EFFECTS SEDATION OTHER Lieberman JA, et al. N Engl J Med. 2005;353(12):1209-1223.

  49. How do we manage this heterogeneity?

  50. We Can Use Evidence-Based Medicine RelevantScientificEvidence ClinicalJudgment EBM Patients’ Values and Preferences Sackett DL, et al. BMJ. 1996;312(7023):71-72. Citrome L, Ketter TA. Int J Clin Pract. 2009;63(3):353-359.

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