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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.
People are affected by bipolar disorder2
People are living with schizophrenia3
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 WHO World mental health report* published in June 2022 indicates that in 2019, 13% of global population is living with mental health disorders. Of these, Schizophrenia, which occurs in 24 million, is a primary concern and Bipolar disorder, another key concern of mental health services around the world, occurs in 40 million people.
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 |  < 30 minute |
2-5 days* Confirmatory/reflect test can take longer |
| Location | On-site on current instrument |
Generally off-site |
| Volume for testing | 0.2 mL |
0.3 - 1 mL |
| Regulatory Clearance | FDA-approved |
No guidance |
| Reference Range | Clear 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 and plasma | 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 |
†Not all assays available in all countries. Please check with your Beckman Coulter representative for availability.
“ 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.”
PHD Director Medical & Scientific Affairs
Therapeutic Drug Monitoring(TDM) Guideline Recommendations**
TDM is an excellent tool to optimize the pharmacotherapy of individual patients prescribed atypical depot or oral antipsychotic drugs.
- Level 1 - Strongly recommended: Clozapine, Olanzapine TDM due to decreased tolerability or intoxication.
- Level 2 - Recommended: Aripiprazole, Paliperidone, Quetiapine, Risperidone TDM due to decreased tolerability or adverse effects at supratherapeutic drug concentrations
Additional Resources
Read more about the history and treatment of Antipsychotic disorder in our blogs.
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.
BLOG Antipsychotic Drug Monitoring for Serious Mental Illness
Antipsychotic drugs are often prescribed for those with SMI. Monitoring blood levels of these medications ensures patient compliance and appropriate care.
Your Questions Answered
Antipsychotic drugs are used to manage and treat symptoms of psychosis. Schizophrenia and bipolar disorder are two common mental illnesses for which antipsychotic medications may be prescribed.
Serious mental illness (SMI) – a mental, behavioral or emotional disorder that severely impairs an individual’s ability to function – is a significant public health concern. Antipsychotic drugs are often prescribed to those with SMI. There is a great need to monitor antipsychotic drug blood levels for those with SMI to ensure they are receiving the best possible care.
Prevalence and Economic Burden of Serious Mental Illnesses (SMI)
Antipsychotic drug monitoring provides healthcare professionals accurate, vital information to help manage their patients’ therapy. Antipsychotic medications in addition to other psychotherapies may help to reduce the intensity and frequency of psychotic symptoms. Patients with untreated schizophrenia4 or bipolar5 may experience increased intensity of symptoms which could be disabling, potentially resulting in additional medical care or could lead to suicide.
Until now, the vital information that antipsychotic drug monitoring assays provide was not readily available to help healthcare professionals manage their patients’ therapy. With antipsychotic drug monitoring, critical information is available when and where it’s most needed.
The need for timely results:
Current methods take days to provide test results. However, rapid antipsychotic therapeutic drug management can return results in 15 minutes or less.
The need for accurate results:
Common assessments of medication status are frequently misleading. A blinded study6 found clinicians had an accuracy rate of only 41% in predicting therapeutic levels compared to diagnostic testing.
Antipsychotic drug monitoring assays run on automated (AU) clinical analyzers, including AU480, AU680 and AU5800 in clinical laboratories.
We’re committed to elevating our therapeutic drug monitoring menu to support clinicians in aiding, monitoring and treating patients with serious mental illnesses. We recognize the need for healthcare providers to be equipped with quantitative insights to manage patient therapy. In partnership with Saladax, we’re addressing that significant, unmet need by providing rapid, low-cost and accurate antipsychotic drug blood level monitoring assays.
Click here to learn more about our full therapeutic drug monitoring, testing and detection menu.
Six drugs can be tested through the five available assays†. These assays address a significant unmet clinical need for patients with SMI by providing healthcare professionals a rapid, low-cost, and accurate antipsychotic drug blood level.
| Drug Name | Brand Name | Prescribed for | FDA Approved | CE Marked |
| Clozapine | Clozaril | Schizophrenia, schizoaffective disorder | Yes | Yes |
| Risperidone or Paliperidone |
Risperdal or Invega |
Schizophrenia, Bipolar Mania, irritability associated with autistic disorder (Risperidone); schizophrenia, schizoaffective disorder (paliperidone) | Yes | |
| Aripiprazole | Abilify | Schizophrenia, bipolar disorder | Yes | |
| Quetiapine | Seroquel | Schizophrenia, bipolar disorder, adjunctive treatment of major depressive disorder (MDD) | Yes | |
| Olanzapine | Zyprexa | Schizophrenia, bipolar disorder | Yes |
†These products may not be available in your country or region at this time. Please fill out the form and we can follow up with you appropriately.
Request More Information
Please complete the form to receive more information on our Antipsychotic Drug Monitoring test kits.
Thank you for your request. A Beckman Coulter representative will contact you shortly.
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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