Support Statement

Supported by an educational grant from BioXcel Therapeutics, Inc. 

Learning Objective

After completing this educational activity, you should be able to:

• Better understand the nature and burden of agitation in bipolar disorder (BP) and schizophrenia (SZ) as it presents in the emergency department (ED) setting 
• Better understand best practice guidelines for effective management of agitation in the ED setting 
• Learn about newly approved therapeutics on the market to treat agitation and evaluate the efficacy and safety of each 

Release, Review, and Expiration Dates

This CME activity was published in April 2023 and is eligible for AMA PRA Category 1 Credit™ through April 30, 2024.

Statement of Need and Purpose

As diseases with multifactorial environmental and genetic contributors, schizophrenia and bipolar disorder are associated with emotional lability and agitation. Severe psychiatric disorders such as bipolar disorder and schizophrenia have been estimated to occur in 5.1% of the population, although individually bipolar I disorder is estimated to occur in 1% of the general population, whereas schizophrenia is believed to occur in a smaller proportion of the population, estimated at 0.25% to 0.64% of all outpatients. These burdens are more concentrated in certain portions of the population, such as unhoused persons, of which approximately 10% are thought to be affected by schizophrenia.    

In consideration of managing the clinical needs of patients with schizophrenia and bipolar disorder, it is important to consider the role of agitation as a limiting factor in provision of both outpatient and inpatient care. According to the World Health Organization, agitation is a major factor that limits the ability to provide appropriate care, and in turn limits general health care, education, housing, and employment for patients with severe mental illness. Moreover, worldwide, only 31% of patients with psychosis receive specialized mental health care, even though half of patients in mental hospitals have a diagnosis of schizophrenia. Patient agitation represents a significant challenge in the emergency department where medical staff are working under pressure managing a diverse range of medical emergencies, making it critical to address agitated behavior safely and effectively. 

Project BETA guidelines concerning the psychopharmacology of agitation, published in 2012, emphasize the importance of nonpharmacologic methods of behavior control and appropriate use of medications in specific conditions to inform the use of therapy. Understanding the specific pathophysiology and underlying pathobiology of agitation, as well as the co-occurrence of agitation with psychiatric illness, delirium, and intoxication must be considered in the choice of therapy. Guidelines emphasize the importance of identifying underlying causes of agitation, rather than simply applying therapy immediately with an antipsychotic or benzodiazepine. However, use of appropriate effective and evidence-based pharmacologic control of agitation remains a major gap in the clinical management of schizophrenia and bipolar disorder, as only 25% of emergency department staff in a survey reported feeling safe at work sometimes to never, whereas more than half of emergency nurses reported being subject to physical or verbal abuse at work in the week prior to being surveyed. 

Many learners who have completed previous activities provided by the CME Institute have requested more education about agitation, including the following topics:  

• More detailed recommendations and literature about managing agitation specifically 
• Neurobiology of agitation 
• Bipolar disorder and agitation 
• Acute management of agitation 
• Treatments for agitation  
• Most effective and safe medications for agitation  
• Emergency treatment of agitation 
• Antidepressant-induced agitation 

Unlabeled and Investigational Usage

The faculty of this educational activity may include discussions of products or devices that are not currently labeled for use by the FDA. Faculty members have been advised to disclose to the audience any reference to an unlabeled or investigational use.

No endorsement of unapproved products or uses is made or implied by coverage of these products or uses.

Please refer to the official prescribing information for each product for discussion of approved indicators, contraindications and warnings.

Review Process

The faculty members agreed to provide a balanced and evidence-based presentation and discussed the topics and CME objectives during the planning sessions. The faculty’s submitted content was validated by CME Institute staff, and the activity was evaluated for accuracy, use of evidence, and fair balance by the Chair and a peer reviewer who is without conflict of interest.

The opinions expressed herein are those of the faculty and do not necessarily reflect the opinions of the CME provider and publisher or the commercial supporter

© Copyright 2023 Physicians Postgraduate Press, Inc.