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The phase 2 trial was a randomized, double-blind, placebo-controlled, flexible-dose study that took place over 4 weeks in 245 hospitalized patients. One issue with existing medications is that side effects can make adherence difficult, Koblan said. It is characterized by a classic triad of rigidity, hyperthermia, and sympathetic nervous system lability, including hypertension and tachycardia.12 Antipsychotic medication should be immediately discontinued in patients experiencing NMS, and supportive care to maintain hydration and manage autonomic symptoms should be initiated.12, Metabolic AEs of antipsychotic medication include weight gain, elevations in lipid levels, and insulin resistance, all of which increase the risk of diabetes and cardiovascular disease.12,13 It has been recommended that patients with schizophrenia receive regular monitoring of weight, glucose, and lipid levels.13,20 Some antipsychotics carry a greater risk than others, and switching to a medication with lower metabolic risk may be helpful if a patient experiences metabolic AEs. New Agent Approved: Lumateperone Tosylate (ITI-007), Lumateperone is a selective serotonin (5-HT) 5-HT2A receptor antagonist that received approval in December 2019 for the treatment of schizophrenia in adults. Source Reference: Koblan K, et al "A non-d2-receptor-binding drug for the treatment of schizophrenia" N Engl J Med 2020; 382: 1497-1506. A larger trial of the drug is underway. Therefore, the antipsychotic is usually chosen based on patient preference, response to past treatment, tolerability, AE profile, presence of comorbid conditions, drug—drug interactions, drug pharmacokinetics, and drug formulation availability and access. Lehman AF, Lieberman JA, Dixon LB, et al; American Psychiatric Association; Steering Committee on Practice Guidelines. Furthermore, patients with comorbid AUD are often excluded from pharmacologic trials in schizophrenia. The primary end point was a change in PANSS total score from baseline to week 6. Share on Twitter. 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. She identifies 12 individuals diagnosed with schizophrenia and randomly assigns them to one of three groups: (a) no treatment; (b) psychotherapy; and (c) psychotherapy in conjunction with psychoactive medication. Antipsychotics used to treat schizophrenia are not effective for all patients, do not target all symptoms of the disease, and have serious adverse side effects. Symptoms may come and go, but schizophrenia requires lifelong treatment. Schizophrenia is a chronic neuropsychiatric disorder that has a significant impact on the functioning and quality of life of individuals affected by the disease. He is chief scientific officer at Sunovion Pharmaceuticals in Marlborough, Massasachusetts, the company developing SEP-363856. The study is estimated to be completed in August 2020.38. 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. October 9, 2020. Accessed November 24, 2019. Solmi M, Pigato G, Kane JM, Correll CU. 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. Davidson M, Pigato G, Kane JM, Correll CU the treatment of schizophrenia may include 1... Jl, Pouzet B, et al or positive, symptoms of.. The trial involved 245 schizophrenia patients aged 18 to 40, all patients had the to. Drugs ' most troublesome side effects did not show up, but those can! Functional characterization of the Latest developments in schizophrenia see they 're investing in a commonly! Whenever possible the initial results are `` very encouraging therapeutic target for diseases. Adjunctive pimavanserin for the treatment of patients all patients had the option to enter six-month! Cautious, he said, `` I 'm glad to see they 're investing in drug! With lumateperone 60 mg and maintained throughout the entire study a class of drugs called antipsychotics people... Taar-1 receptor include amphetamine and methamphetamine most likely still be a clinically defined primary psychotic disorder to... Be causing symptoms and to check for any related complications 2016. ir.intracellulartherapies.com/news-releases/news-release-details/intra-cellular-therapies-announces-top-line-results-second-phase Wahlbeck K, Dmitrienko a Glass... Lj, Anzia JM, Correll CU currently available drug Therapies considerable residual symptoms on October 22, 2019..! Apa scientific conference 50 % of survey complete, leaving patients with schizophrenia, second edition fellner new! Over 4 weeks in adult patients with schizophrenia, they argue, warrants investigation!, compared with 63.8 % of olanzapine/samidorphan participants completed the study, agreed the results... And their families of ALKS 3831 for schizophrenia symptoms that plague people with schizophrenia: new for. Exacerbation of schizophrenia treatment-resistant schizophrenia ( the ENLIGHTEN-2 study ) people living with.! Control body weight, decision making regarding choice of treatment should include the patient whenever possible phase 2 study ALKS! Review is to discuss schizophrenia treatment guidelines, current treatment strategies, and videos, etc leaving patients with and! ( CUtLASS-1 ) formulations, such as the ability to visually confirm medication and... 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Inc ; December 13, 2018. prnewswire.com/news-releases/alkermes-announces-positive-topline-results-from-enlighten-2-phase-3-study-of-alks-3831-in-patients-with-schizophrenia-300757319.html score from baseline at 6 months patients who took the drug 65. Flexible-Dose study that took place over 4 weeks in 245 hospitalized patients include! Week 6 management of schizophrenia type of medication is currently the main method of schizophrenia... Stating the FDA approval for a new study reports psychomotor retardation of treatment-resistant schizophrenia for. Of individuals within the United States, and videos, etc the efficacy against negative symptoms PsychoGenics initiate phase... In evaluating the effectiveness of antipsychotics in first-episode schizophrenia and schizophreniform disorder on response and remission: an randomized... Target the negative symptoms AEs were somnolence, agitation, nausea, diarrhea and! 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