American Psychiatric Association website, Lieberman JA, Stroup TS, McEvoy JP, et al; Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Investigators. Schizophrenia is a chronic neuropsychiatric disorder that has a significant impact on the functioning and quality of life of individuals affected by the disease. From long-lasting Injectables to a whole new drug class, here are the five most important cutting-edge treatments. © 2020 MJH Life Sciences and AJMC. Symptoms of hallucinations and delusions mark this mental disorder, changing the lives of patients and their families. Instead it stimulates a different brain receptor, called TAAR1. https://doi.org/10.37765/ajmc.2020.43012Introduction, Schizophrenia is a chronic neuropsychiatric disorder affecting an estimated 3.5 million individuals in the United States.1 It is characterized by a combination of positive symptoms (eg, hallucinations, delusions, disorganized thoughts or speech, and bizarre behaviors), negative symptoms (lack of motivation, drive, enjoyment, social interactions), cognitive dysfunction (affecting attention, memory, executive functioning, social interactions), and motor disturbances that can lead to functional impairment and poor health-related quality of life (QOL).2, At present, there is no cure for schizophrenia, and treatment guidelines recommend a combined approach with pharmacologic agents and psychological interventions for first-episode psychosis, acute exacerbations, and prevention of relapse of psychosis.3 Multiple agents are currently available for the treatment of schizophrenia; however, many fall short of their therapeutic goals, as adherence, cognitive dysfunction, negative symptoms, residual positive symptoms, and adverse effects (AEs) remain a challenge for many patients.2. Transdermal delivery systems may have benefits over other formulations, such as the ability to visually confirm medication adherence and possible improved tolerability. All rights reserved. A key secondary end point of improvement on the Clinical Global Impression—Severity of illness (CGI-S) scale was also observed with olanzapine/samidorphan compared with placebo (P = .002). Kane JM, Agid O, Baldwin ML, et al. Lumateperone (ITI-007) for the treatment of schizophrenia: placebo-controlled clinical trials and an open-label safety switching study. Schizophrenia affects a small percentage of patients within the United States; however, its effect on physical function and QOL is significant. Furthermore, 80% to 90% of individuals will experience a relapse at some point in the course of their illness, often related to nonadherence to maintenance therapy.23 Market research analysis has identified several gaps in pharmacologic therapy for schizophrenia, which include a need for agents that improve cognition, are capable of treating negative symptoms, improve treatment-resistant schizophrenia, have improved AE profiles, and improve adherence.23 Novel therapies that attempt to fill these treatment gaps have recently been approved or are currently being researched and will be discussed in more detail here. A Study of ALKS 3831 in Adults With Schizophrenia (The ENLIGHTEN-2 Study). The primary end point was a change in PANSS total score from baseline to week 6. The increased prolactin may result in galactorrhea and menstrual disturbances in women and sexual dysfunction and gynecomastia in men, which can contribute to medication nonadherence.13 Long-term effects of hyperprolactinemia may include an increased risk of osteoporosis and breast or endometrial cancer.12 Switching to a medication with a lower risk for hyperprolactinemia may be advisable if patients are affected by elevations in prolactin.22, Novel Treatment Strategies and Emerging Agents for Schizophrenia. Intra-Cellular Therapies announces positive top-line results from the first phase 3 trial of ITI-007 in patients with schizophrenia and confirms the unique pharmacology of ITI-007 in a separate positron emission tomography study [news release]. 136. New Schizophrenia Treatment Guideline Released. A larger trial of the drug is underway. APA Releases New Practice Guideline on Treatment of Patients with Schizophrenia. Accessed February 25, 2020. Treatment options for neurodevelopmental disorders like schizophrenia and autism are currently limited. NEWS RELEASE New England Journal of Medicine Publishes Pivotal Results Evaluating Sunovion’s SEP-363856 for the Treatment of Schizophrenia 4/15/2020 —Signicantly greater improvement in the Positive and Negative Symptom Scale was demonstrated in schizophrenia patients treated with SEP-363856, a TAAR1 agonist, compared to placebo— Accessed February 14, 2020. The phase 2 trial was a randomized, double-blind, placebo-controlled, flexible-dose study that took place over 4 weeks in 245 hospitalized patients. acmigold15; October 11, 2020 ; Blog; 0 ... Research into the treatment of schizophrenia is long overdue, as it can be a devastating disease process. An experimental drug may ease a range of symptoms that strike people with schizophrenia, without the side effects of existing medications, an early clinical trial suggests. Accessed November 24, 2019. Author disclosure: Dr Maroney has the following relevant financial relationships with commercial interests to disclose: Authorship information: Concept and design; acquisition of data; analysis and interpretation of data; drafting of the manuscript; critical revision of the manuscript for important intellectual content; supervision. Dr. Ken Duckworth is medical director of the National Alliance on Mental Illness. Remington G. Tardive dyskinesia: eliminated, forgotten, or overshadowed? ", Goff, who wrote an editorial published with the study, agreed the initial results are "very encouraging. Approximately 30% of individuals with schizophrenia are considered resistant to currently available drug therapies. are registered trademarks of Newsmax Media, Inc. Newsmax TV, and Newsmax World are trademarks of Newsmax Media, Inc. Thune Sees Challenge to Biden Win Going Down Like 'Shot Dog'... More GOP Lawmakers Join Effort to Challenge Electoral College... Trump Wants Congress to Amend COVID-19 Relief Bill... Trump Issues Wave of Pardons, Including for Ex-Aide Papadopoulos... Newt Gingrich: Trump Should 'Probably' Attend Biden Inauguration... Thune Sees Challenge to Biden Win Going Down Like 'Shot Dog', More GOP Lawmakers Join Effort to Challenge Electoral College, Trump Wants Congress to Amend COVID-19 Relief Bill, Trump Issues Wave of Pardons, Including for Ex-Aide Papadopoulos, Newt Gingrich: Trump Should 'Probably' Attend Biden Inauguration. A psychiatrist experienced in treating schizophrenia usually guides treatment. Accessed November 12, 2020. Share on Pinterest . Both doses of asenapine transdermal were statistically superior to placebo in the primary end point with a least squares mean change of —22.1 for asenapine 3.8 mg/24 hours and -20.4 for asenapine 7.6 mg/24 hours compared with approximately 15.5 with placebo (P <.01 for both). However, a new treatment using the deep brain stimulation technique could improve the condition of patients. Roluperidone is a cyclic amide derivative developed to target the negative symptoms of and cognitive dysfunction in schizophrenia. The most common AEs were somnolence, agitation, nausea, diarrhea, and dyspepsia for SEP-363856. Alkermes announces positive topline results from ENLIGHTEN-2 phase 3 study of ALKS 3831 in patients with schizophrenia [news release]. McClellan J, Sikich L, Findling RL, et al. Learning Objectives • Review clinical advances in our understanding of schizophrenia • Update knowledge on novel treatments for schizophrenia. Includes information about psychosis and a psychotic episode. Significant side effects did not show up, but those issues can take time to manifest, Duckworth noted. He is chief scientific officer at Sunovion Pharmaceuticals in Marlborough, Massasachusetts, the company developing SEP-363856. Agonists of the TAAR-1 receptor include amphetamine and methamphetamine. ACADIA Pharmaceuticals Announces Positive Top-line Results from ADVANCE Trial of Pimavanserin as Treatment for Negative Symptoms of Schizophrenia [news release]. After that point, all patients had the option to enter a six-month extension study where the drug was given to everyone. Medical writing and editorial support: Brittany Hoffmann-Eubanks, PharmD, MBA. clinicaltrials.gov/ct2/show/NCT03397134. Leucht S, Cipriani A, Spineli L, et al. Dr Brannan is chief medical officer at Karuna Therapeutics and a neuroscience drug development expert. T.gondii parasites. "Negative" refers to what's lost, and the symptoms include flattened emotions, difficulty feeling pleasure and withdrawal from others. Other concerns such as change in body weight, blood glucose, lipids, and prolactin levels were comparable with placebo.51 In September 2019, the Developing Innovative Approaches for Mental Disorders (DIAMOND) phase 3 trial program was initiated to demonstrate the safety, efficacy, and tolerability of SEP-363856.52 The phase 3 program will include 4 trials (DIAMOND 1-4) and enroll more than 1000 adolescents and adults with schizophrenia; it has a target completion date of 2022.52. DORIA phase III trial hits primary endpoint [news release]. clinicaltrials.gov/ct2/show/NCT02970292. The oral pill from Intra-Cellular Therapies should be available in early 2020. It can take between 2 and 4 weeks to show an initial response and up to 6 months or longer for the full therapeutic effect.12, Prompt, effective pharmacologic treatment of individuals with schizophrenia within the first 5 years after their initial episode is crucial due to pathophysiologic changes occurring in the brain during this time.3 The acute treatment of schizophrenia focuses on reducing psychotic symptoms while minimizing AEs.13 After a patient is stabilized, maintenance therapy is continued to help prevent relapse, increase socialization, and improve self-care and mood.3 The incidence of relapse in schizophrenia is significantly higher among those who do not receive maintenance therapy compared with those who do (60%-80% vs 18%-32%, respectively).3,15,16, While used as first-line agents, SGAs have an increased risk of metabolic AEs, with some carrying a greater potential risk than others, and this must be considered when selecting a therapy for schizophrenia management.13 FGAs are efficacious in reducing positive symptoms, such as hallucinations, uncooperativeness, hostility, and paranoid ideations, along with fostering improvement in thought disorganization and blunted affect.3 The use of these agents is complicated by the severity of EPS, which typically precludes their use as first-line agents.3 Additionally, clozapine has shown efficacy as a second-line option in patients with a poor or partial response to other agents.17 Clozapine is distinguished by its greater efficacy in treating positive symptoms in patients with treatment-resistant schizophrenia and by the relative absence of EPS.3 The use of clozapine is precluded by several rare but serious and potentially fatal AEs that require close monitoring. Comparative efficacy and tolerability of 15 antipsychotic drugs in schizophrenia: a multiple-treatments meta-analysis [published correction appears in. Accessed November 22, 2019. However, a greater placebo effect occurred in this trial when compared with other lumateperone trials, making the results potentially less reliable.4,27, Olanzapine/samidorphan is a combination therapy that includes a fixed dose of samidorphan (a μ-opioid receptor antagonist) and olanzapine.31 The intended purpose of this combination therapy is to help reduce the olanzapine-associated weight gain and adverse metabolic effects with samidorphan while maintaining the established therapeutic effect of olanzapine in the treatment of schizophrenia.23,31, Olanzapine/samidorphan was evaluated in two phase 3 studies. Earlier course of the Latest developments in schizophrenia with new-generation antipsychotics: a multiple-treatments meta-analysis [ correction! 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