The Week in Review: April 15-19

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This week, Psychiatric Times® discussed a wide variety of psychiatric issues and industry updates, from a comparison of clozapine dose regimens to the management of borderline personality disorder in obstetrics units.

New Phase 3 Study Results on Lumateperone, An Adjunctive Therapy to Antidepressants

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Positive topline results from study 501 showed that lumateperone (Caplyta) 42 mg was effective as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD).

Investigators in study 501 found that lumateperone 42 mg, when given once daily as adjunctive therapy to antidepressants, met the primary endpoint by demonstrating a statistically significant and clinically meaningful reduction in the MADRS total score when compared with placebo at week 6. They randomized 485 patients with MDD to lumateperone 42 mg plus antidepressant or placebo plus antidepressant (1:1) in order to evaluate the efficacy and safety of lumateperone as an adjunct to antidepressants. Continue Reading

Publication of Phase 1 Results Announced for BPL-003

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Phase 1 results of BPL-003 (5-methoxy-N,N-dimethyltryptamine benzoate)—a short-duration psychedelic tryptamine that binds to multiple serotonergic receptors—have been published in The Journal of Psychopharmacology.

The phase 1 double-blind, placebo-controlled study, which involved a single ascending dose, examined the safety, tolerability, pharmacokinetics, and pharmacodynamics of BPL-003 in 44 psychedelic-naïve healthy volunteers. Participants were divided into 7 cohorts and administered either a single dose of BPL-003 ranging from 1 mg to 12 mg or a placebo. Continue Reading

Management of Borderline Personality Disorder in an Obstetric Unit

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Providing care to individuals with borderline personality disorder (BPD) within inpatient medical settings can bring unique challenges for patients and medical teams. Individuals with BPD are more likely to have limited medical literacy, engage in challenging behavior and verbal altercations with their medical team, and be psychiatrically misdiagnosed.

They also often are considered high-risk patients in hospital settings due to the increased possibility of intentional or unintentional self-harm behaviors. These include overdoses, impulsive verbal arguments, unprotected sexual activity, poor medication and treatment adherence, nonsuicidal self-injurious behaviors, and suicide attempts. Continue Reading

Clozapine: Once-Daily or Divided Dosing?

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Clozapine is the gold-standard antipsychotic for treatment-resistant schizophrenia (TRS). Divided daily dosing is indicated in the package insert for clozapine. This recommendation is based on elimination half-life data showing that higher nocturnal clozapine levels may increase risk of adverse effects and the potential for breakthrough symptoms.

This recommendation has been challenged as daily bedtime dosing may reduce adverse effects such as orthostatic hypotension and daytime sedation, increase adherence, and not affect risk of seizures. However, studies comparing clozapine dose regimens and outcomes and adverse effects are limited. Continue Reading

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