WRITTEN BY: Annie Lennon Researchers from the UK and France have discussed a mechanism of action behind the infamous Toxoplasma gondii parasite transferred to humans from cat litter that may lead to the development of new treatments for schizophrenia and other neurological … A potential new class of treatments for schizophrenia that operate via a novel mechanism appear to be emerging and a number of pharmaceutical companies have active development programmes in this area. Links will not be permitted. Intra-Cellular Therapies announces top-line results from the second phase 3 trial of ITI-007 in patients with schizophrenia (Study ‘302) [news release]. Updated June 27, 2018. Metformin for weight loss and metabolic control in overweight outpatients with schizophrenia and schizoaffective disorder. Practice guideline for the treatment of patients with schizophrenia, second edition. Lumateperone 60 mg/day demonstrated statistically significant superiority in the change in the Positive and Negative Syndrome Scale (PANSS) total score versus placebo, with a least squares mean change from baseline on the PANSS total score of —14.5 points versus –10.3 points with placebo (P = .022). Roluperidone is a cyclic amide derivative developed to target the negative symptoms of and cognitive dysfunction in schizophrenia. The guideline focuses on assessment and treatment planning, which are integral to … Medication is currently the main method of treating schizophrenia, and the primary type of medication is a class of drugs called antipsychotics. Researchers have … The draft guidelines acknowledge that there may be clinically meaningful distinctions in response and tolerability among the various antipsychotic medications; however, no definitive evidence exists of consistent superior efficacy, with the exception of clozapine for treatment-resistant schizophrenia.12. ... FDA Advisory Board In Favor of ALKS 3831 for Schizophrenia. The first phase 3 trial (n = 450), called ITI-007-301, was a multicenter, randomized, double-blind, fixed-dose, placebo-controlled trial.29 Participants were randomized (1:1:1) to either lumateperone 60 mg, lumateperone 40 mg, or placebo once daily in the morning for 4 weeks. Although pimavanserin did not achieve statistical significance in the primary end point, there were significant changes in secondary end points that measured negative symptom improvement.40 Pimavanserin is currently in phase 2 development for its utility as an adjunct in managing negative symptoms of schizophrenia. Agonists of the TAAR-1 receptor include amphetamine and methamphetamine. 2020;26:S55-S61. Tests and screenings. Efficacy of Lu AF35700 in Patients with Early-in-disease or Late-in-disease Treatment-resistant Schizophrenia (Anew). Approximately 30% of individuals with schizophrenia are considered resistant to currently available drug therapies. APA Releases New Practice Guideline on Treatment of Patients with Schizophrenia. Genetic Associations May Lead to New Treatments for Schizophrenia. Second-generation antipsychotics (SGAs) are recommended as first-line treatment for acute schizophrenia symptom management (although first-generation antipsychotics [FGAs] may be appropriate for some patients).3 In 2009, the APA released a guideline watch5 for practitioners, which highlighted key clinical trials that had been published between 2002 and 2009.6-11 Most recently, in May 2019, the APA released a draft of updated guidelines for the treatment of schizophrenia in adults.12 The updated proposed guidelines indicate that antipsychotic medication for the treatment of schizophrenia is only one component of the overall treatment paradigm. Peluso MJ, Lewis SW, Barnes TR, Jones PB. Additionally, there were clinically significant improvements in secondary end points, including CGI-S score, PANSS positive subscale score, PANSS negative subscale score, and PANSS general psychopathology subscale score. The study had 2 primary end points: (1) percent change from baseline in body weight at 6 months, and (2) the proportion of participants with 10% or more weight gain from baseline at 6 months. Second-generation versus first-generation antipsychotic drugs for schizophrenia: a meta-analysis. Treatment options for neurodevelopmental disorders like schizophrenia and autism are currently limited. In particular, AEs such as the hypoesthesia and dysgeusia associated with sublingual asenapine could be avoided by utilizing the transdermal patch.26 A release date for this product has not yet been confirmed. A Study of ALKS 3831 in Adults With Schizophrenia (The ENLIGHTEN-2 Study). The trial involved 245 schizophrenia patients aged 18 to 40, all in the earlier course of the disease. Cambridgeshire and Peterborough NHS Foundation Trust’s early intervention mental health service CAMEO will lead a major global study as UK partner, to investigate the causes and impact of schizophrenia on high risk adolescents and young adults, and to try to find effective early treatments. Schizophrenia is associated with an increased prevalence of alcohol use disorder (AUD), 1 which is also associated with relapse and poorer outcomes. Solmi M, Pigato G, Kane JM, Correll CU. Also, no statistically significant differences in vital signs, weight, metabolic profile, or EPS emerged, compared with placebo. Furthermore, significant antipsychotic efficacy was observed as early as week 1 with lumateperone 60 mg and maintained throughout the entire study. It affects 0.6% to 1.9% of individuals within the United States, and currently there is no cure. Experts were hopeful that the findings, published April 16 in the New England Journal of Medicine, will lead to a new treatment option. Accessed February 14, 2020. He said: "There have been no breakthroughs in the treatment of schizophrenia for 50 years because it is such a complicated illness. In the last 20 years, a number of studies have shown that cognitive‐behavioral psychotherapy is effective to reduce the symptoms of schizophrenia, especially when combined with … Among 120 patients who took the drug, 65% were responding by week four. While there is a laundry list of antipsychotic medications for schizophrenia, they are decades old. Physical exam. Symptoms may come and go, but schizophrenia requires lifelong treatment. There are currently 841 patients enrolled in the 3-part study, which consists of a screening, maintenance, and double-blind phase, with a primary end point of time to relapse. clinicaltrials.gov/ct2/show/NCT02970292. 1 While some of these therapies may help treat the negative and cognitive symptoms of schizophrenia, a few are associated with QTc interval prolongation. 28, 2020 . Accessed November 22, 2019. ... Accessed February 14, 2020. F17464 (20 mg twice daily) versus placebo treatment for 6 weeks in adult patients with acute exacerbation of schizophrenia. Beyond that, existing medications only address one group of schizophrenia symptoms — the hallucinations, delusions and confused thoughts that doctors call "positive" symptoms. Updated February 7, 2020. Grigg J, Worsley R, Thew C, Gurvich C, Thomas N, Kulkarni J. Antipsychotic-induced hyperprolactinemia: synthesis of world-wide guidelines and integrated recommendations for assessment, management and future research. © 2020 MJH Life Sciences™ and Clinical Care Targeted Communications, LLC. clinicaltrials.gov/ct2/show/NCT03397134. Furthermore, the TAAR-1 receptor seems to respond the most to dopamine, followed by glutamine, compared with tryptamine, norepinephrine, and serotonin.4 As a result of these features, TAAR-1 agonists are being targeted for treatment of schizophrenia.47,48 Two TAAR-1 agonists are currently in development: SEP-363856 and R05263397.47,49, In May 2019, SEP-363856 received breakthrough designation from the FDA as a novel agent for the treatment of schizophrenia.50 Breakthrough status was granted based on the pivotal phase 2 data, along with data from a 2018 six-month open-label extension study (SEP361-202) that evaluated safety and tolerability. 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