Lumateperone for Schizophrenia and Bipolar Disorder
Recruiting in Palo Alto (17 mi)
+12 other locations
Age: < 18
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Intra-Cellular Therapies, Inc.
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia or bipolar disorder.
What makes the drug Lumateperone unique for treating schizophrenia and bipolar disorder?
Lumateperone is unique because it modulates serotonin, dopamine, and glutamate neurotransmission simultaneously, which may help with a wide range of symptoms in schizophrenia and bipolar disorder. It also has a favorable metabolic profile, potentially leading to less weight gain compared to other antipsychotics.
12456What data supports the effectiveness of the drug Lumateperone for treating schizophrenia and bipolar disorder?
Lumateperone, also known as Caplyta, has been shown to be effective in treating schizophrenia and bipolar depression, with studies highlighting its benefits over other antipsychotic medications. It works by affecting serotonin, dopamine, and glutamate in the brain, and has been found to have favorable outcomes in terms of weight and body measurements compared to other similar drugs.
12346Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are taking medication for ADHD, you must have been on a stable treatment for 30 days before the study and continue it throughout the study.
Eligibility Criteria
This trial is for children and teenagers with schizophrenia or bipolar disorder. Specific details about who can join are not provided, but typically participants must meet certain health standards and have a diagnosis of the conditions being studied.Participant Groups
The study is testing Lumateperone, a medication intended to treat psychiatric conditions like schizophrenia and bipolar disorder in young people over a period of 26 weeks. It's an open-label trial, meaning both the researchers and participants know what treatment is being given.
1Treatment groups
Experimental Treatment
Group I: LumateperoneExperimental Treatment1 Intervention
Lumateperone is already approved in United States for the following indications:
🇺🇸 Approved in United States as Caplyta for:
- Schizophrenia
- Bipolar I or II disorder (bipolar depression)
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Clinical SiteOrlando, FL
Clinical SiteSan Diego, CA
Clinical SiteMiami, FL
Clinical SiteColton, CA
More Trial Locations
Loading ...
Who is running the clinical trial?
Intra-Cellular Therapies, Inc.Lead Sponsor
References
Lumateperone: First Approval. [2021]Lumateperone (Caplyta®) is a novel, orally available agent developed by Intra-Cellular Therapies (under a license from Bristol-Myers Squibb) for the treatment of schizophrenia and other neuropsychiatric and neurological disorders. Lumateperone is a first-in-class selective and simultaneous modulator of serotonin, dopamine and glutamate. In December 2019, lumateperone received its first global approval in the USA for the treatment of schizophrenia in adults. The drug is also under clinical development for bipolar depression, behavioural disorders associated with dementia and Alzheimer's disease, sleep maintenance insomnia and major depressive disorders. This article summarizes the milestones in the development of lumateperone leading to this first approval for the treatment of schizophrenia.
Lumateperone: New Drug or Same Old Drug With a New Dress? [2021]Lumateperone (Caplyta®) is a drug recently approved by the U.S. Food and Drug Administration for the treatment of schizophrenia. But is it a new drug with promise, or a similar drug with new wrappings? This drug, similar to other second- and third-generation serotonin dopamine antagonists, is a potent antagonist at higher serotonin 2A receptors as well as brief binding to dopamine 1 and dopamine 2 (D2) receptors, but also has partial agonism at presynaptic D2 and indirect modulation of N-Methyl-D-aspartic acid (NMDA) and alpha-amino-3-hydroxy-5-methyl-isoxazolepropionic acid (AMPA) of the glutamine receptors. The current article reviews the putative effects of this novel mechanism of action on symptoms of schizophrenia as discussed in Phase II and III trials. A case study applies the information to a clinical situation. [Journal of Psychosocial Nursing and Mental Health Services, 58(6), 9-12.].
Safety and tolerability of lumateperone 42 mg: An open-label antipsychotic switch study in outpatients with stable schizophrenia. [2021]Lumateperone is a mechanistically novel agent FDA-approved for the treatment of schizophrenia. Efficacy and favorable tolerability of lumateperone were demonstrated in 2 short-term placebo-controlled studies in patients with schizophrenia. This open-label study investigated the short-term safety/tolerability of lumateperone in outpatients with stable schizophrenia switched from previous antipsychotic treatment.
Lumateperone for the Treatment of Adults With Schizophrenia: a Systematic Review. [2022]Lumateperone (LUM) is the U.S. Food and Drug Administration approved atypical antipsychotic agent for adults with schizophrenia (SCZ) and bipolar depression (for both bipolar I and bipolar II disorder as as monotherapy or as adjunctive treatment to lithium or valproate). LUM simultaneously modulates serotonin, dopamine, and glutamate neurotransmission. The foregoing pleiotropic mechanism of action is predictive of therapeutic benefits across multiple domains of psychopathology in SCZ (i.e., positive, negative, cognitive, and prosocial symptoms). Herein, the overarching aim is to synthesize the extant literature reporting on the efficacy, safety, and tolerability of LUM in adults with SCZ.
Evaluating lumateperone for its use in treating depressive episodes associated with bipolar I or II disorder in adults. [2023]Lumateperone is a novel antipsychotic medication that has recently received approval by the United States Food and Drug Administration for treatment of major depressive episodes of type I and II bipolar disorder. It is approved for use as monotherapy or as an adjunctive treatment to lithium or valproic acid.
Illuminating Hope for Mental Health: A Drug Review on Lumateperone. [2023]This drug review provides a comprehensive analysis of a novel antipsychotic called lumateperone, marketed as Caplyta. Lumateperone gained FDA approval in 2019 for treating schizophrenia and later, in 2021, for treating bipolar depression. The review begins by delving into lumateperone's mechanism of action, which involves the partial agonism of the dopamine D2 receptor as well as its unique effects on the dopamine transporter, N-methyl-D-aspartate (NMDA) receptor, and serotonin transporter. Additionally, the study examines lumateperone's distinctive pharmacokinetics. Moreover, this review assesses lumateperone's metabolic profile and highlights its favorable outcomes regarding mean body weight, BMI, and waist circumference, surpassing those of other second-generation antipsychotic medications. The study explicitly emphasizes the efficacy and safety of lumateperone in treating schizophrenia and bipolar depression associated with bipolar I and II disorders. An extensive investigation of multiple clinical trials provides compelling evidence of lumateperone's advantages over existing antipsychotic medications. The review also acknowledges the limitations of lumateperone compared to other antipsychotics. In conclusion, this drug review underscores the importance of further research to uncover the additional limitations of lumateperone while acknowledging its promising benefits and potential for advancing treatment options.