In this very special newsletter, we include information regarding lumateperone and its potential use for bipolar depression. We also share guidance regarding laboratory testing in the practice of psychopharmacology, key points from a presentation on the management of delirium, and our practical research summaries (Quick Takes).
Lumateperone (Caplyta) for Bipolar Depression
- What is lumateperone approved for?
- In December 2019, the FDA approved lumateperone for the treatment of schizophrenia. You can learn more here.
- What happened during May 2021?
- In May 2021, the FDA accepted a supplemental New Drug Application (sNDA) of lumateperone for the treatment of bipolar depression.
- What is an sNDA?
- An application from the pharmaceutical company to the FDA for changing an off-label use of a drug to additional on-label use.
- Does it mean that lumateperone has now been approved for bipolar depression?
- No. It simply means that the FDA will evaluate the proof of efficacy and safety. It may take years to process, it can be expensive, and it is not a guarantee of approval.
- What do we know about its efficacy for bipolar disorder?
- Three large, randomized, placebo-controlled, quadruple-blind trials assessed the efficacy of lumateperone for bipolar I and bipolar II depression.
- One of them was negative.
- The other 2 trials had a small-to-medium effect size (0.27–0.56).
- Lumateperone’s favorable trials remained positive when broken down into bipolar I and bipolar II subgroups.
- Three large, randomized, placebo-controlled, quadruple-blind trials assessed the efficacy of lumateperone for bipolar I and bipolar II depression.
- What are its most common side effects?
- The most commonly reported adverse events were somnolence, dizziness, and nausea.
- How might it be different from existing medications?
- It has a low affinity for the dopamine D2 receptor (39%), even lower than clozapine and quetiapine (60%).
- Its main advantage over other atypical antipsychotics is likely to be tolerability.
The manufacturer published a press release in May 2021. Learn more.
Laboratory Testing in the Practice of Psychopharmacology With Sandra A. Jacobson, M.D.
In this interview, Dr. Sandra Jacobson discusses laboratory testing in the practice of psychopharmacology and reviews monitoring strategies for patients taking psychotropic medications with the propensity to cause various adverse effects.
Interview highlights include the following:
- The use of tricyclic antidepressants and older monoamine oxidase inhibitors for older patients should be avoided due to increased risk for toxicity.
- Esketamine may be a useful adjunct medication for patients with treatment-resistant depression and elevated inflammatory markers.
Learn more and earn 0.5 CME credits here.
Management of Delirium
In this presentation, Dr. Scott Beach discusses the assessment and management of delirium. He reviews research on medications with evidence for its prevention and management and discusses special considerations in delirium, such as catatonia and COVID-19 delirium.
Special Considerations in Delirium: Catatonia and COVID-19
- Catatonia is increasingly recognized in patients with delirium, particularly the hypoactive variety.
- In patients with catatonia and delirium, consider first using benzodiazepines but also amantadine and memantine.
- For patients with COVID-19 delirium, use melatonin and alpha-2 agonists prior to antipsychotics.
- Chlorpromazine may be a good choice for an antipsychotic.
- Other agents, like IV haloperidol and SGAs, can be used.
Learn more and earn 1.0 CME credit here.
Quick Takes: Informing Your Practice
Citalopram for Acute and Preventive Efficacy in Bipolar Depression: A Randomized, Double-Blind, Placebo-Controlled Trial
- This new randomized trial suggests that the efficacy of antidepressants for the short- or long-term treatment of bipolar depression is no greater than placebo. Learn more.
Association of Psychiatric Disorders With Mortality Among Patients With COVID-19
- When infected with the COVID-19 virus, patients who have a schizophrenia spectrum diagnosis are 2.7 times more likely to die than people without that diagnosis, even after correcting for concurrent risk factors. Learn more.
Listen to or read the full volume, and earn 0.5 CME credits here.
References
Intra-Cellular Therapies. (2021, May 3). Intra-Cellular Therapies Announces FDA Acceptance of CAPLYTA® (lumateperone) sNDAs for the Treatment of Bipolar Depression. INVESTORS | Intra-Cellular Therapies Inc. https://ir.intracellulartherapies.com/node/11726/pdf
Aiken, C. (2021, May 14). A New Option for Bipolar Depression. Psychiatric Times. https://www.psychiatrictimes.com/view/new-option-bipolar-depression
