Antipsychotic Drug Monitoring

There is a clinical unmet need for rapid and accurate antipsychotic drug blood level monitoring assays to aid in the treatment of Serious Mental Illness (SMI).


In partnership with Saladax®, we’ve expanded our therapeutic drug monitoring menu with on-demand testing to help clinicians provide the best possible care to those with SMI.



Serious Mental Illness

Serious Mental Illnesses (SMIs) are mental health conditions resulting in functional impairments that substantially interfere with or limit major life activities1. We are committed to supporting clinicians in monitoring and treating all patients – including those with SMI – providing quantitative insights to manage patient therapies with timely and critical data.

 
45 Million
People are affected by bipolar disorder2
 
24 Million
People are living with schizophrenia3
 
<20
percent
of treatment-resistant schizophrenia patients receive clozapine4

The Clinical Need for Antipsychotic Drug Monitoring Antipsychotic Drug Monitoring improves care for those with Serious Mental Illness by aiding medication adherence.5,6
The Center for Mental Health Services has determined that, of those with Serious Mental Illness, 90% have been diagnosed with conditions such as schizophrenia or bipolar disorder. In 2020, there were an estimated 14.2 million adults aged 18 or older in the United States with SMI – 5.6% of all US adults

Schizophrenia

A severe, chronic condition that causes an abnormal interpretation of reality. Hallucinations, highly disordered thinking, reduced ability to function, and delusions are common.

Bipolar Disorder

Causes drastic mood, energy and activity swings. During manic episodes, people feel euphoric with increased energy. During depressive episodes, people feel deep sadness with low energy

Antipsychotic Drug Monitoring in Clinical Decision Making

For clozapine and similar medications, therapeutic drug monitoring is important for making clinical decisions. In this presentation, The Role of Antipsychotic TDM in Clinical Decision Making: The Example of Clozapine, the unique place of clozapine for treatment-resistant schizophrenia and the role of TDM in treatment are discussed.


Parameter Beckman Chemistry Platforms LC-MS/MS
Turnaround Time checkmark< 30 minute 2-5 days*
Confirmatory/reflect test can take longer
Location checkmarkOn-site on current instrument Generally off-site
Volume for testing checkmark0.2 mL 0.3 - 1 mL
Regulatory Clearance checkmarkFDA-approved No guidance
Reference Range checkmarkClear cut-offs Reference ranges can vary

Accurate Treatment Starts with Accurate Testing

Get results within hours rather than days. Every patient is unique. Accurate, timely information is required to make informed treatment decisions. Our extensive portfolio of antipsychotic drug monitoring assays† offers the right tools to enhance clinical decision making.

Drug Name Prescribed For Intended Use Chemistry Platforms
Clozapine Schizophrenia, schizoaffective disorder Psychiatry Clozapine Assay Kit is intended for the in vitro quantitative measurement of clozapine in human serum AU480, AU680, AU5800, DxC 700 AU
Risperidone* or Paliperidone* Schizophrenia, Bipolar Mania, irritability associated with autistic disorder (Risperidone); schizophrenia, schizoaffective disorder (paliperidone) Psychiatry Total Risperidone Assay Kit is intended for the in vitro quantitative measurement of risperidone and Paliperidone (9-hydroxyrisperidone) in human serum AU480, AU680, AU5800, DxC 700 AU
Aripiprazole* Schizophrenia, bipolar disorder Psychiatry Total Aripiprazole Assay Kit is intended for the in vitro quantitative measurement of total aripiprazole (aripiprazole plus dehydroaripiprazole) in human serum AU480, AU680, AU5800, DxC 700 AU
Quetiapine* Schizophrenia, bipolar disorder, adjunctive treatment of major depressive disorder (MDD) Psychiatry Quetiapine Assay Kit is intended for the in vitro quantitative measurement of quetiapine in human serum AU480, AU680, AU5800, DxC 700 AU
Olanzapine* Schizophrenia, bipolar disorder Psychiatry Olanzapine Assay Kit is intended for the in vitro quantitative measurement of olanzapine in human serum AU480, AU680, AU5800, DxC 700 AU

*Assays are not yet available for use in the US

“ Therapeutic drug monitoring can improve patient outcomes by avoiding unnecessary dose escalations, reducing adverse drug reactions and facilitating the switch to alternative therapies when appropriate.”
Arindam Ghosh, MBBS,
PHD Director Medical & Scientific Affairs

Clozapine Monitoring

Clozapine, an atypical antipsychotic, is the gold standard for managing treatment resistant schizophrenia, decreasing the likelihood of suicide and hallucinations. Monitoring blood levels of clozapine is vital to reduce the risks from serious potential side effects as well as patient adherence to therapy.

Additional Resources

Read more about the history and treatment of Antipsychotic disorder in our blog.

BLOG Brief History of Antipsychotic Drugs

Mental illnesses are now recognized as treatable conditions. Historically, though, people with these conditions were ridiculed and stigmatized. Learn more about the tortuous history of SMI.

Brief History of Antipsychotic Drugs

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Click here to learn more about our full therapeutic drug monitoring, testing and detection menu.

Saladax is a registered trademark of Saladax Biomedical, Inc.

†Not all assays available in all countries. Please check with your Beckman Coulter representative for availability.

1. Substance Abuse and Mental Health Services Administration Center for Mental Health Services. 58 Fed. Reg. 29422. (Final Notice May 20, 1993)

2. James, S. et al. (2018). Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. The Lancet, 392(10159), 1789–1858. https://doi.org/10.1016/s0140-6736(18)32279-7

3. Schizophrenia. (2022, January 10). World Health Organization. Retrieved June 10, 2022, from https://www.who.int/news-room/fact-sheets/detail/schizophrenia

4. Saloni Dattani, Hannah Ritchie and Max Roser (2021) - "Mental Health". Published online at OurWorldInData.org. Retrieved from: 'https://ourworldindata.org/mental-health [Online Resource]

5. Kelly, D. et al. (2018). Addressing Barriers to Clozapine Underutilization: A National Effort. Psychiatric services (Washington, D.C.), 69(2), 224–227. https://doi.org/10.1176/appi.ps.201700162

6. Transforming the Understanding and Treatment of Mental Illness. (2021). National Institute of Mental Health (NIMH). Retrieved January 26, 2022, from https://www.nimh.nih.gov/health/statistics/mental-illness Accessed 12 July 2022

7. Byerly, M., et al. (2005). A comparison of electronic monitoring vs. clinician rating of antipsychotic adherence in outpatients with schizophrenia. Psychiatry Research, 133(2–3), 129–133. https://doi.org/10.1016/j.psychres.2004.11.002

8. Keck P. (2014). Monitoring pharmacotherapy response, safety, and tolerability to enhance adherence in bipolar disorder. The Journal of clinical psychiatry, 75(5), e12. https://doi.org/10.4088/JCP.13010tx4c

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