Balancing Efficacy and Safety in Schizophrenia: Current and Emerging Approaches

You are leaving Medscape Education

Cancel Continue

CME & Education

Becker MH, Maiman LA. Sociobehavioral determinants of compliance with health and medical care recommendations. Med Care. 1975;13:10-24.
Berry MD, Gainetdinov RR, Hoener MC, et al. Pharmacology of human trace amine-associated receptors: therapeutic opportunities and challenges. Pharmacol Ther. 2017;180:161-180.
Bowie CR, Leung WW, Reichenberg A, et al. Predicting schizophrenia patients' real-world behavior with specific neuropsychological and functional capacity measures. Biol Psychiatry. 2008;63:505-511.
Brannan SK, Sawchak S, Miller AC, et al. Muscarinic cholinergic receptor agonist and peripheral antagonist for schizophrenia. N Engl J Med. 2021;384:717-726.
Bugarski-Kirola D, Arango C, Fava M, et al. ADVANCE: phase 2, randomized, double-blind, placebo-controlled study ofadjunctive pimavanserin in patients with negative symptoms of schizophrenia. Presented at: 2020 Congress of the Schizophrenia International Research Society; April 48, 2020; virtual meeting. Oral presentation.
Correll CU. What are we looking for in new antipsychotics? J Clin Psychiatry. 2011;72 (suppl 1):9-13.
Correll CU, Koblan KS, Hopkins SC, et al. Safety and Effectiveness of SEP-363856 in Schizophrenia: Results of a 6-Month, Open-Label Extension Study. CNS Spectr. 2021;26:148-149.
Correll CU, Newcomer JW, Silverman B, et al. Effects of olanzapine combined with samidorphan on weight gain in schizophrenia: a 24-week phase 3 study. Am J Psychiatry. 2020;177:1168-1178.
Cummings JL, Devanand DP, Stahl SM. Dementia-related psychosis and the potential role for pimavanserin. CNS Spectr. 2020:1-9.
Diagnostic and Statistical Manual of Mental Disorders (DSM-5), Fifth Edition. American Psychiatric Association Publishing. 2013.
Dedic N, Jones PG, Hopkins SC, et al. SEP-363856, a novel psychotropic agent with a unique, non-D₂ receptor mechanism of action. J Pharmacol Exp Ther. 2019;371:1-14.
Dworak H, Hopkins S, Li Y, et al. Effects of SEP-363856, a novel TAAR1 agonist, on negative symptoms in schizophrenia: results across an acute study and a 6-month extension study. Presented at: American Psychiatric Association Annual Meeting; May 1-5, 2021; virtual meeting. Poster #P11-086.
Eiden LE, Weihe E. VMAT2: a dynamic regulator of brain monoaminergic neuronal function interacting with drugs of abuse. Ann N Y Acad Sci. 2011;1216:86-98.
Goff DC. Promising evidence of antipsychotic efficacy without dopamine D2-receptor binding. N Engl J Med. 2020;382:1555-1556.
Grunder G, Carlsson A, Wong DF. Mechanism of new antipsychotic medications: occupancy is not just antagonism. Arch Gen Psychiatry. 2003;60:974-977.
Hopkins SC, Ogirala A, Colbert A, et al. The safety profile of the TAAR1 agonist, SEP363856, is distinct from atypical antipsychotics. Presented at: American Psychiatric Association Annual Meeting; May 1-5, 2021; virtual meeting. Poster #P11-5356.
Hunter NS, Anderson KC, Cox A. Pimavanserin. Drugs Today (Barc). 2015;51:645-652.
Jauhar S, Veronese M, Nour MM, et al. Determinants of treatment response in first-episode psychosis: an ¹⁸F-DOPA PET study. Mol Psychiatry. 2019;24:1502-1512.
Johnson BA. Update on neuropharmacological treatments for alcoholism: scientific basis and clinical findings. Biochem Pharmacol. 2008;75:34-56.
Koblan KS, Kent J, Hopkins SC, et al. A Non-D2-receptor-binding drug for the treatment of schizophrenia. N Engl J Med. 2020;382:1497-1506.
Koblan KS. SEP-363856: A compound with a non-D2 receptor mechanism of action for the treatment of schizophrenia: update. Presented at: 2020 Congress of the Schizophrenia International Research Society; April 4-8, 2020; virtual meeting.
Lybalvi (olanzapine and samidorphan) [prescribing information]. Alkermes, Inc. Approved 2021. Revised May 2021.
Martin WF, Correll CU, Weiden PJ, et al. Mitigation of olanzapine-induced weight gain with samidorphan, an opioid antagonist: a randomized double-blind phase 2 study in patients with schizophrenia. Am J Psychiatry. 2019;176:457-467.
McCutcheon RA, Reis Marques T, Howes OD. Schizophrenia -- an overview. JAMA Psychiatry. 2020;77:201-210.
Miller GM. The emerging role of trace amine-associated receptor 1 in the functional regulation of monoamine transporters and dopaminergic activity. J Neurochem. 2011;116:164-176.
Moran SP, Maksymetz J, Conn PJ. Targeting muscarinic acetylcholine receptors for the treatment of psychiatric and neurological disorders. Trends Pharmacol Sci. 2019;40:1006-1020.
Pompili M, et al. CNS Neurol Disord Drug Targets. 2017;16:870-884.
Pompili M, Giordano G, Luciano M, et al. Unmet needs in schizophrenia. CNS Neurol Disord Drug Targets. 2017;16:870-884.
Potkin SG, et al. J Clin Psychiatry. 2020;81:19m12769.
Potkin SG, Kunovac J, Silverman BL, et al. Efficacy and safety of a combination of olanzapine and samidorphan in adult patients with an acute exacerbation of schizophrenia: outcomes from the randomized, phase 3 ENLIGHTEN-1 study. J Clin Psychiatry. 2020;81:19m12769.
Salomon JA, Vos T, Hogan DR, Gagnon M, et al. Common values in assessing health outcomes from disease and injury: disability weights measurement study for the Global Burden of Disease Study 2010. Lancet. 2012;380:2129-2143.
Stahl SM. Stahl's essential psychopharmacology: Neuroscientific basis and practical applications. Cambridge University Press. 2013.
Tandon R, et al. Ann Gen Psychiatry. 2020;19:42.
Tandon R, Lenderking WR, Weiss C, et al. The impact on functioning of second-generation antipsychotic medication side effects for patients with schizophrenia: a worldwide, cross-sectional, web-based survey [published correction appears in Ann Gen Psychiatry. 2020 Aug 10;19:45]. Ann Gen Psychiatry. 2020;19:42.
Wimalasena K. Vesicular monoamine transporters: structure-function, pharmacology, and medicinal chemistry. Med Res Rev. 2011;31:483-519.

CME / ABIM MOC

Balancing Efficacy and Safety in Schizophrenia: Current and Emerging Approaches

Authors: Christoph U. Correll, MD
CME / ABIM MOC Released: 8/2/2021; Reviewed and Renewed: 9/14/2022
THIS ACTIVITY HAS EXPIRED FOR CREDIT
Valid for credit through: 9/14/2023, 11:59 PM EST

Start Activity

Target Audience and Goal Statement

This activity is intended for psychiatrists and primary care providers (PCPs) involved in the care of patients with schizophrenia.

The goal of this activity is to help clinicians increase their awareness of the spectrum of symptoms associated with schizophrenia, the uses and limitations of current antipsychotic medications, and the rationale and clinical data for investigational therapies being studied for the management of schizophrenia.

Upon completion of this activity, participants will:

Have increased knowledge regarding the
- Factors to consider for individualizing the selection of an antipsychotic therapy for the management of schizophrenia 
- Limitations associated with currently available antipsychotic medications 
- Clinical trial data for investigational antipsychotic therapies being studied for the management of schizophrenia

Disclosures

As an organization accredited by the ACCME, Medscape, LLC, requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest. The ACCME defines "relevant financial relationships" as financial relationships in any amount, occurring within the past 12 months, including financial relationships of a spouse or life partner, that could create a conflict of interest.

Medscape, LLC, encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration, at first mention and where appropriate in the content.

Faculty

Christoph U. Correll, MD

Professor
Department of Psychiatry and Molecular Medicine
Donald and Barbara Zucker School
of Medicine at Hofstra/Northwell
Hempstead, New York, United States
Professor and Chair
Department of Child and Adolescent Psychiatry
Charité University Medicine
Berlin, Germany

Disclosures

Disclosure: Christoph U. Correll, MD, has disclosed the following relevant financial relationships:
Served as an advisor or consultant for: Acadia; Alkermes; Allergan; Angelini; Gedeon Richter; Intra-Cellular Therapies; Janssen/Johnson & Johnson; Karuna; LB Pharma; Lundbeck; MedAvante-ProPhase; MedinCell; Merck; Mitsubishi Tanabe Pharma; Mylan; Neurocrine; Noven; Otsuka; Pfizer; Recordati; ROVI; Sumitomo Dainippon; Sunovion; Supernus; Takeda; Teva
Served as a speaker or a member of a speakers bureau for: Angelini; Gedeon Richter; Janssen/Johnson & Johnson; Lundbeck; Mitsubishi Tanabe Pharma; Mylan; Otsuka; Recordati; Sumitomo Dainippon; Sunovion
Received grants for clinical research from: Janssen; Takeda
Owns stock, stock options, or bonds from: LB Pharma
Other: DSMB member or chair: Lundbeck; Relmada; ROVI; Teva

Steering Committee

Leslie Citrome, MD, MPH

Clinical Professor of Psychiatry and Behavioral Sciences
New York Medical College
Valhalla, New York

Disclosures

Leslie Citrome, MD, MPH Clinical Professor of Psychiatry and Behavioral Sciences New York Medical College Valhalla, New York Disclosure: Leslie Citrome, MD, MPH, has disclosed the following relevant financial relationships:
Served as an advisor or consultant for: ACADIA Pharmaceuticals Inc.; Alkermes, Inc.; Allergan, Inc.; Forum Pharmaceuticals; Indivior PLC; Intra-Cellular Therapies, Inc.; Janssen Pharmaceuticals; Lundbeck, Inc.; Merck & Co., Inc.; Neurocrine Biosciences, Inc.; Noven Pharmaceuticals, Inc.; Otsuka Pharmaceutical Co., Ltd.; Pfizer Inc.; Shire; Sunovion Pharmaceuticals Inc.; Takeda Pharmaceuticals North America, Inc.; Teva Pharmaceuticals USA; Vanda Pharmaceuticals Inc.
Served as a speaker or a member of a speakers bureau for: ACADIA Pharmaceuticals Inc.; Alkermes, Inc.; Allergan, Inc.; Janssen Pharmaceuticals; Lundbeck, Inc.; Merck & Co., Inc.; Neurocrine Biosciences, Inc.; Otsuka Pharmaceutical Co., Ltd.; Pfizer Inc.; Shire; Sunovion Pharmaceuticals Inc.; Takeda Pharmaceuticals North America, Inc.; Teva Pharmaceuticals USA; Vanda Pharmaceuticals Inc.
Owns stock, stock options, or bonds from: Bristol Myers Squibb Company; Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; Lilly; Merck & Co., Inc.; Pfizer Inc.

Christoph Correll, MD

Professor of Psychiatry and Molecular Medicine
Zucker School of Medicine
Hofstra/Northwell
Medical Director of Recognition and Prevention Program
The Zucker Hillside Hospital
Glen Oaks, New York

Disclosures

Disclosure: Christoph Correll, MD, has disclosed the following relevant financial relationships:
Served as an advisor or consultant for: Acadia; Alkermes; Allergan; Angelini; Axsome; Gedeon Richter; Gerson Lehrman Group; Indivior; IntraCellular Therapies; Janssen/J&J; Karuna; LB Pharma; Lundbeck; MedAvante-ProPhase; MedInCell; Medscape; Merck; Mitsubishi Tanabe Pharma; Mylan; Neurocrine; Noven; Otsuka; Pfizer; Recordati; Rovi; Servier; Sumitomo Dainippon; Sunovion; Supernus; Takeda; Teva
Served as a speaker or a member of a speakers bureau for: Allergan; Angelini; Gedeon Richter; Janssen/J&J; Lundbeck; Otsuka; Pfizer; Recordati; Sunovion
Received grants for clinical research from: Janssen; Takeda
Owns stock, stock options, or bonds from: LB Pharma

Melissa DelBello, MD, MS

Dr Stanley and Mickey Kaplan Professor and Chair of Psychiatry and Behavioral Neuroscience
University of Cincinnati
Cincinnati, Ohio

Disclosures

Disclosure: Melissa DelBello, MD, MS, has disclosed the following relevant financial relationships:
Served as an advisor or consultant for: Alkermes, Inc.; Allergan, Inc.; AssureRx Health, Inc.; Janssen Pharmaceuticals; Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; Lundbeck, Inc.; Neuronetics; Otsuka Pharmaceutical Co., Ltd.; Pfizer Inc.; Sunovion Pharmaceuticals Inc.; Supernus Pharmaceuticals, Inc.
Served as a speaker or a member of a speakers bureau for: Otsuka Pharmaceutical Co., Ltd.; Sunovion Pharmaceuticals Inc.
Received grants for clinical research from: ACADIA Pharmaceuticals Inc.; Allergan, Inc.; Janssen Pharmaceuticals; Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; Lundbeck, Inc.; Otsuka Pharmaceutical Co., Ltd.; Pfizer Inc.; Sunovion Pharmaceuticals Inc.; Supernus Pharmaceuticals, Inc.

Joseph Goldberg, MD

Clinical Professor of Psychiatry
Icahn School of Medicine at Mount Sinai
New York, New York

Disclosures

Disclosure: Joseph Goldberg, MD, has disclosed the following relevant financial relationships:
Served as an advisor or consultant for: BioXcel; Otsuka; Sage Pharmaceuticals; Sunovion; WebMD
Served as a speaker or a member of a speakers bureau for: Allergan; Intracellular Therapies; Otsuka; Sunovion

Diana O. Perkins, MD, MPH

Professor of Psychiatry
Medical Director, OASIS (Outreach and Support Intervention Service)
University of North Carolina, Chapel Hill School of Medicine
Chapel Hill, North Carolina

Disclosures

Disclosure: Diana O. Perkins, MD, MPH, has disclosed the following relevant financial relationships:
Served as an advisor or consultant for: Alkermes, Inc.
Received grants for clinical research from: Boehringer Ingelheim Pharmaceuticals, Inc.

Amanda J. Simonton, PhD, APRN, PMHNP-BC

Clinical Assistant Professor
University of Texas at Austin School of Nursing
Austin, Texas

Disclosures

Disclosure: Amanda Simonton, PhD, APRN, PMHNP-BC, has disclosed the following relevant financial relationships:
Served as an advisor or consultant for: Creative Educational Concepts
Served as a speaker or a member of a speakers bureau for: College of Pharmacy, University of Texas at Austin

Editors

Rob Lowney

Principal/Managing Director, CMEology

Disclosures

Disclosure: Rob Lowney has disclosed no relevant financial relationships.

Stephen Strudwick, PhD

Scientific Director, CMEology

Disclosures

Disclosure: Stephen Strudwick, PhD, has disclosed no relevant financial relationships.

Meg Monday

Senior Director, Content Development

Disclosures

Disclosure: Meg Monday has disclosed no relevant financial relationships.

CME Reviewer

Robert Morris, PharmD

Associate Director, Accreditation and Compliance, Medscape, LLC

Disclosures

Disclosure: Robert Morris, PharmD, has disclosed the following relevant financial relationships:
Served as an advisor or consultant for: ViiV Healthcare
Owns stock, stock options, or bonds from: GlaxoSmithKline

None of the nonfaculty planners for this educational activity have relevant financial relationship(s) to disclose with ineligible companies whose primary business is producing, marketing, selling, reselling, or distributing healthcare products used by or on patients.

Peer Reviewer

This activity has been peer reviewed and the reviewer has disclosed no relevant financial relationships.

Accreditation Statements

Presented through a collaboration between CMEology and Medscape Education.

In support of improving patient care, Medscape, LLC is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

For Physicians

Medscape, LLC designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit(s)™ . Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 0.25 MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Contact This Provider

For questions regarding the content of this activity, contact the accredited provider for this CME/CE activity noted above. For technical assistance, contact [email protected]

Instructions for Participation and Credit

There are no fees for participating in or receiving credit for this online educational activity. For information on applicability and acceptance of continuing education credit for this activity, please consult your professional licensing board.

This activity is designed to be completed within the time designated on the title page; physicians should claim only those credits that reflect the time actually spent in the activity. To successfully earn credit, participants must complete the activity online during the valid credit period that is noted on the title page. To receive AMA PRA Category 1 Credit™, you must receive a minimum score of 75% on the post-test.

Follow these steps to earn CME/CE credit*:

Read the target audience, learning objectives, and author disclosures.
Study the educational content online or printed out.
Online, choose the best answer to each test question. To receive a certificate, you must receive a passing score as designated at the top of the test. We encourage you to complete the Activity Evaluation to provide feedback for future programming.

You may now view or print the certificate from your CME/CE Tracker. You may print the certificate but you cannot alter it. Credits will be tallied in your CME/CE Tracker and archived for 6 years; at any point within this time period you can print out the tally as well as the certificates from the CME/CE Tracker.

*The credit that you receive is based on your user profile.

From Medscape Education Psychiatry & Mental Health

CME / ABIM MOC

Balancing Efficacy and Safety in Schizophrenia: Current and Emerging Approaches

Authors: Christoph U. Correll, MDFaculty and Disclosures

THIS ACTIVITY HAS EXPIRED FOR CREDIT

CME / ABIM MOC Released: 8/2/2021; Reviewed and Renewed: 9/14/2022

Valid for credit through: 9/14/2023, 11:59 PM EST

processing....

Pre-Assessment Survey

Before you begin, please take this brief survey.

Page 1 of 4

CME / ABIM MOC Information Download Slides

Full Live Event Audio

Print
Like Tweet

Disclaimer

The educational activity presented above may involve simulated, case-based scenarios. The patients depicted in these scenarios are fictitious and no association with any actual patient, whether living or deceased, is intended or should be inferred. The material presented here does not necessarily reflect the views of Medscape, LLC, or any individuals or commercial entities that support companies that support educational programming on medscape.org. These materials may include discussion of therapeutic products that have not been approved by the US Food and Drug Administration, off-label uses of approved products, or data that were presented in abstract form. These data should be considered preliminary until published in a peer-reviewed journal. Readers should verify all information and data before treating patients or employing any therapies described in this or any educational activity. A qualified healthcare professional should be consulted before using any therapeutic product discussed herein.

References

Faculty and Disclosures

Faculty

Christoph U. Correll, MD

Steering Committee

Leslie Citrome, MD, MPH

Christoph Correll, MD

Melissa DelBello, MD, MS

Joseph Goldberg, MD

Diana O. Perkins, MD, MPH

Amanda J. Simonton, PhD, APRN, PMHNP-BC

Editors

Rob Lowney

Stephen Strudwick, PhD

Meg Monday

CME Reviewer

Robert Morris, PharmD

Peer Reviewer

CME / ABIM MOC

Balancing Efficacy and Safety in Schizophrenia: Current and Emerging Approaches

Target Audience and Goal Statement

Disclosures

Faculty

Christoph U. Correll, MD

Steering Committee

Leslie Citrome, MD, MPH

Christoph Correll, MD

Melissa DelBello, MD, MS

Joseph Goldberg, MD

Diana O. Perkins, MD, MPH

Amanda J. Simonton, PhD, APRN, PMHNP-BC

Editors

Rob Lowney

Stephen Strudwick, PhD

Meg Monday

CME Reviewer

Robert Morris, PharmD

Peer Reviewer

Accreditation Statements

For Physicians

Instructions for Participation and Credit

Balancing Efficacy and Safety in Schizophrenia: Current and Emerging Approaches

Pre-Assessment Survey