New treatments for patients with schizophrenia may be on the horizon, according to research presented at the annual meeting of the American Psychiatric Association (APA) in San Francisco. Relapse prevention in schizophrenia with new-generation antipsychotics: a systematic review and exploratory meta-analysis of randomized, controlled trials. Keep discussions on topic, avoid personal attacks and threats of any kind. Schizophrenia is associated with an increased prevalence of alcohol use disorder (AUD), 1 which is also associated with relapse and poorer outcomes. Schizophrenia is a severe disease that affects 1% of the worldwide population and reliable, effective treatments are almost nonexistent. Dr Brannan is chief medical officer at Karuna Therapeutics and a neuroscience drug development expert. "Negative" refers to what's lost, and the symptoms include flattened emotions, difficulty feeling pleasure and withdrawal from others. And taking the … 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. While there is a laundry list of antipsychotic medications for schizophrenia, they are decades old. News. New trial results question standard treatment plan for rheumatoid arthritis Jul 08, 2020 A novel psychotherapeutic approach to schizophrenia based on psychological well-being Dublin, Ireland: Alkermes; November 29, 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. Symptoms of hallucinations and delusions mark this mental disorder, changing the lives of patients and their families. A new schizophrenia treatment is being developed that relies on interactions and relationships has been successful in treating a… The information presented on this website is not intended as specific medical advice and is not a substitute for professional medical treatment or diagnosis. San Diego, CA: ACADIA Pharmaceuticals Inc; July 22, 2019. biospace.com/article/acadia-pharmaceuticals-announces-top-line-results-from-phase-3-enhance-trial-of-pimavanserin-as-adjunctive-treatment-for-patients-with-schizophrenia/. November 16, 2020 Source: University of Leeds Summary: New research into how a common parasite infection alters human behavior could help development of treatments for schizophrenia … sardaa.org/resources/about-schizophrenia/. Pimavanserin was well tolerated and demonstrated similar AEs compared with placebo (40.4% vs 36.9%, respectively). ENLIGHTEN-1 was a double-blind, randomized trial that evaluated the efficacy, safety, and tolerability of olanzapine/samidorphan compared with olanzapine alone and placebo over 4 weeks in 403 patients experiencing an acute exacerbation of schizophrenia.32 Individuals were randomized 1:1:1 to receive either a bilayer fixed-dose tablet of 10 mg samidorphan combined with either 10 or 20 mg of olanzapine, olanzapine 10 or 20 mg daily as monotherapy, or placebo. Marlborough, MA, and Paramus, NJ: Sunovion Pharmaceuticals Inc and PsychoGenics Inc; May 10, 2019. news.sunovion.com/press-release/sunovion-and-psychogenics-announce-sep-363856-has-received-fda-breakthrough-therapy. Anticholinergic medications (eg, benztropine) can be added to the current regimen to address acute dystonia or pseudoparkinsonism; however, they can cause additional AEs such as dry mouth, blurred vision, and constipation.13 Benzodiazepines or β-blockers, such as propranolol, may be prescribed to help manage akathisia.12,13, TD is defined by abnormal movements that emerge after months or years of treatment with an antipsychotic medication.18 The movements are usually slow and athetoid or rapid choreiform jerks; both types of movements commonly manifest in the mouth, face, jaw, tongue, hands, or feet.13 The strategy for managing TD is to lower the dose of the antipsychotic drug or to change to quetiapine or clozapine, which are associated with a lower risk of TD symptoms than other antipsychotic drugs.18 Additionally, vesicular monoamine transporter 2 inhibitors may be used to help manage symptoms of TD.19, NMS is a rare but potentially life-threatening AE typically seen within the first month of antipsychotic treatment. Lumateperone (ITI-007) for the treatment of schizophrenia: placebo-controlled clinical trials and an open-label safety switching study. Research into the treatment of schizophrenia is long overdue, as it can be a devastating disease process. T.gondii parasites. Significant side effects did not show up, but those issues can take time to manifest, Duckworth noted. ISM is a technological advancement that allows for the release of drugs based on in situ formulation of biodegradable matrices after the administration of a liquid carrier. Overall, the effectiveness was maintained, Koblan said. Secuado [prescribing information]. Genetic Associations May Lead to New Treatments for Schizophrenia. 2,3 Adherence with (limited) treatment options for this patient population are suboptimal. Olanzapine/Samidorphan • Samidorphan (SAM) is an opioid antagonist at the µ-opioid receptor, with … 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. 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 psychiatrist experienced in treating schizophrenia usually guides treatment. 136. Accessed November 24, 2019. clinicaltrials.gov/ct2/show/NCT02694328. New treatment strategies, such as modulators of serotonin and glutamate, agonists of TAAR-1, and antagonists of σ-2, and new dosage forms that aid in adherence have the potential to improve the lives and outcomes of individuals with schizophrenia. 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. Davidson M, Saoud J, Staner C, et al. Funding source: This activity is supported by an educational grant from Alkermes, Inc. November 2, 2020. 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. Suboptimal treatment, significant AEs, and challenges related to nonadherence create a need for new agents to better manage schizophrenia. Efficacy and Safety of Adjunctive Pimavanserin for the Treatment of Schizophrenia (ENHANCE-1). Schizophrenia is a chronic neuropsychiatric disorder that has a significant impact on the functioning and quality of life of individuals affected by the disease. Updated August 29, 2019. A larger trial of the drug is underway. Accessed November 20, 2019. ACADIA Pharmaceuticals announces top-line results from phase 3 ENHANCE trial of pimavanserin as adjunctive treatment for patients with schizophrenia [news release]. However, a new treatment using the deep brain stimulation technique could improve the condition of patients. Treatment of early-onset schizophrenia spectrum disorders (TEOSS): rationale, design, and methods. Drug-induced parkinsonism may also be experienced by patients and can manifest as tremors, rigidity, impaired gait, and psychomotor retardation. The most recently published schizophrenia treatment guidelines from the American Psychiatric Association (APA) were released in 2004.3 These treatment guidelines recommend that the selection of pharmacotherapy be individualized based on patient characteristics and preference. Virtual FDA Advisory Committee Meeting to Review New Drug Application for ALKS 3831 for Treatment of Schizophrenia and Bipolar I Disorder Tentatively Scheduled for Oct. 9, 2020. 2020. doi: 10.1176/appi.ajp.2020.19121279. Includes information about psychosis and a psychotic episode. This protein … Developing a therapeutic alliance is important to the overall success of the treatment plan, particularly to address distressing symptoms of schizophrenia and unwanted AEs from pharmacotherapy. 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. Symptoms may come and go, but schizophrenia requires lifelong treatment. CPFT joins international research partnership to find new treatments for schizophrenia. Though the team stress the sample size was too small to show if Methotrexate could work as an add-on treatment for schizophrenia, they found a ‘puzzling’ therapeutic effect on symptoms of early schizophrenia. The American Psychiatric Association (APA) has released a new evidence-based practice guideline for the treatment of schizophrenia. The study is estimated to be completed in August 2020.38. Experts were hopeful that the findings, published April 16 in the New England Journal of Medicine, will lead to a new treatment option. Currently available antipsychotics, which are thought to work primarily via modulation of dopamine, largely target positive symptoms.4 As a result, many patients are left with residual negative and cognitive symptoms.4 To address these gaps in therapy, new research combined with an increased understanding of the etiology and pathophysiology of schizophrenia is leading to the development of novel agents with the goal of improving schizophrenia management. Alkermes announces positive topline results from ENLIGHTEN-2 phase 3 study of ALKS 3831 in patients with schizophrenia [news release]. Olanzapine also demonstrated similar improvements from baseline PANSS scores compared with placebo (P = .004). Tests and screenings. Physical exam. Pimavanserin is a 5-HT2A inverse agonist currently approved for the treatment of psychosis associated with Parkinson disease. A Study of ALKS 3831 in Adults With Acute Exacerbation of Schizophrenia (the ENLIGHTEN-1 Study). Currently, once-monthly and trimonthly intramuscular injectable formulations of paliperidone are available.37 The manufacturer is currently conducting a phase 3 trial for a formulation of paliperidone palmitate that can be administered every 6 months. Further, decision making regarding choice of treatment should include the patient whenever possible. Efficacy of Lu AF35700 in Patients with Early-in-disease or Late-in-disease Treatment-resistant Schizophrenia (Anew). News release. The most common AEs (≥5%) were headache, somnolence, and insomnia. Biochemical and functional characterization of the trace amine-associated receptor 1 (TAAR1) agonist RO5263397. Address correspondence to: mmaroney@pharmacy.rutgers.edu. Methotrexate is often used to treat inflammatory diseases such as rheumatoid arthritis and Crohn's disease. Accessed November 22, 2019. 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. This may be done to help rule out other problems that could be causing symptoms and to check for any related complications. The treatment team also may include a psychologist, social worker, psychiatric nurse and … Roluperidone is a cyclic amide derivative developed to target the negative symptoms of and cognitive dysfunction in schizophrenia. Cat Parasite Gives Clues on New Drug Targets for Schizophrenia. The first medications for schizophrenia were discovered serendipitously in the 1950s, with subsequent “me-too” drugs targeting the same limited number of neurotransmitters. Citrome L, Zeni CM, Correll CU. I was pleasantly surprised to read this article stating the FDA approval for a new drug trial for schizophrenia. About half were randomly assigned to take SEP-363856 capsules once a day, while the rest received placebo capsules. Dublin, Ireland: Alkermes; November 19, 2019. prnewswire.com/news-releases/alkermes-submits-new-drug-application-to-us-food-and-drug-administration-for-alks-3831-for-treatment-of-schizophrenia-and-bipolar-i-disorder-300960407.html. And because many of the traditional medications used to treat the disorder cause major side effects, those with schizophrenia … Schwartz MD, Canales JJ, Zucchi R, Espinoza S, Sukhanov I, Gainetdinov RR. Novel agent promising for the treatment of schizophrenia Apr 16, 2020 Not all antipsychotics increase the risk of diabetes and raise cholesterol—some may be protective clinicaltrials.gov/ct2/show/NCT02970292. Share on Pinterest . Accessed November 12, 2020. clinicaltrials.gov/ct2/show/NCT03397134. DORIA phase III trial hits primary endpoint [news release]. Beyond that, existing medications only address one group of schizophrenia symptoms — the hallucinations, delusions and confused thoughts that doctors call "positive" symptoms. 2020;26:S55-S61. Accessed February 14, 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. 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]. Share on LinkedIn. Finding New Treatments for Schizophrenia 2020 APA Scientific Conference 50% of survey complete. These include severe neutropenia or agranulocytosis and cardiac complications, such as myocarditis or cardiomyopathy.13, First- and Second-Generation Antipsychotic AE Overview, Early in the course of treatment with antipsychotics, common AEs include sedation, orthostatic changes in blood pressure, and anticholinergic AEs such as dry mouth, constipation, and difficulty with urination.12 Prolongation of the QTc interval can also be a concern because of the potential for life-threatening torsades de pointes.12, Akathisia is the most common EPS seen in patients treated with antipsychotics.13 It presents as restless movements, and patients may describe a sense of inner restlessness. Agonists of the TAAR-1 receptor include amphetamine and methamphetamine. American. And I'm cautiously optimistic about it.". A new perspective for schizophrenia: TAAR1 agonists reveal antipsychotic- and antidepressant-like activity, improve cognition and control body weight. The goals of therapy for acute treatment of schizophrenia are to reduce the acute symptoms and return the patient back to their baseline level of functioning.12 Once maintenance therapy is initiated, the goal is to prevent the recurrence of symptoms, optimize functioning, and improve QOL. Accessed February 18, 2020. The purpose of this review is to discuss schizophrenia treatment guidelines and summarize current treatment strategies and emerging agents for the management of schizophrenia. Secondary Source New England Journal of Medicine Furthermore, patients with comorbid AUD are often excluded from pharmacologic trials in schizophrenia. … Accessed February 18, 2020. Share on Twitter. Accessed February 7, 2020. O n December 23, the FDA approved a new drug for schizophrenia, lumateperone, which was said to be a “first-in-class” medication, suggesting that its mechanism of action differed from antipsychotic drugs … PANSS Total Score Change from Baseline … Metformin for weight loss and metabolic control in overweight outpatients with schizophrenia and schizoaffective disorder. Schizophrenia and Related Disorders Alliance of America website. Miami, FL, and Jersey City, NJ: Noven Pharmaceuticals, Inc; October 15, 2019. www.biospace.com/article/releases/u-s-fda-approves-secuado-asenapine-transdermal-system-the-first-and-only-transdermal-patch-for-the-treatment-of-adults-with-schizophrenia/. While there is a laundry list of antipsychotic medications for schizophrenia… -30-25-20-15-10-5. American Journal of Psychiatry. Consensus development conference on antipsychotic drugs and obesity and diabetes. News Nov 17, 2020 | Original story from the University of Leeds . Instead it stimulates a different brain receptor, called TAAR1. In some cases, hospitalization may be needed. Learn more about Schizophrenia causes, symptoms, resources, and treatment from Psych Central. Among 120 patients who took the drug, 65% were responding by week four. Treatment. Updated February 10, 2020. 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). 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). Hear details from the phase II trial of xanomeline-trospium and how it assists in the treatment of acute schizophrenia… Janssen Submits Paliperidone Palmitate 6-Month (PP6M) Supplemental New Drug Application to US FDA for Treatment of Schizophrenia in Adults. APA Releases New Practice Guideline on Treatment of Patients with Schizophrenia. TUESDAY, Jan. 28, 2020 (HealthDay News) -- Good news for people with schizophrenia: Long-term antipsychotic-drug treatment does not increase the risk of heart disease. From long-lasting Injectables to a whole new drug class, here are the five most important cutting-edge treatments. Author affiliation: Megan Maroney, PharmD, BCPP, is a clinical associate professor, Ernest Mario School of Pharmacy at Rutgers, The State University of New Jersey, Piscataway, NJ; clinical psychiatric pharmacist, Monmouth Medical Center, Long Branch, NJ. A study by clinical scientists at The University of … Cognitive effects of MIN-101 in patients with schizophrenia and negative symptoms: results from a randomized controlled trial. New Formulation Approved: Asenapine Transdermal System, Asenapine transdermal system is the only transdermal medication approved for the treatment of schizophrenia, achieving approval in October 2019.24 Approval was based on efficacy data from trials with sublingual asenapine as well as a 6-week, fixed-dose, randomized, double-blind, placebo-controlled study in 616 adults with schizophrenia.24,25 Patients were randomized to a dose of asenapine 3.8 mg/24 hours, 7.6 mg/24 hours, or placebo. Cautious, he said, because this was a short-term trial. After a month, almost two-thirds of patients on the drug were showing a response — meaning their scores on a standard measure of symptoms had improved by at least 20%. That compared with 44% of patients given a placebo. But, Goff said, they do not ease the "negative" symptoms that plague people with schizophrenia. Solmi M, Pigato G, Kane JM, Correll CU. Fellner C. New schizophrenia treatments address unmet clinical needs. Summary: Schizophrenia may, in part, be caused by immune system dysfunction, a new study reports. 2. Relatively newer, second-generation antipsychotics are less likely to cause those side effects, but they can spur weight gain and high blood sugar and cholesterol levels. To address these concerns, many investigational agents are being researched to improve overall treatment, negative symptoms, cognitive dysfunction, adherence, antipsychotic AE profiles, and residual and/or treatment-resistant schizophrenia. Schizophrenia is … NOV 20, 2020 7:30 AM PST. ", Goff, who wrote an editorial published with the study, agreed the initial results are "very encouraging. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia [published correction appears in. A key secondary end point evaluated the proportion of patients with 7% or more weight gain from baseline at 6 months. Patches: established and emerging transdermal treatments in psychiatry. acmigold15; October 11, 2020 ; Blog; 0 ... Research into the treatment of schizophrenia is long overdue, as it can be a devastating disease process. If … Older, "first-generation" drugs can cause movement impairments similar to those seen in Parkinson's disease — tremors, joint stiffness and coordination problems. The primary end point was a change in PANSS total score from baseline to week 6. McClellan J, Sikich L, Findling RL, et al. Safety was also evaluated in ENLIGHTEN-2; overall, 62.4% of olanzapine/samidorphan participants completed the study compared with 63.8% of olanzapine participants. Serious AEs were observed in 2.5% of the olanzapine treatment group and 3.6% of the olanzapine/samidorphan treatment group during the 6-month trial period.34 A new drug application was approved, and the drug has a Prescription Drug User Fee Act date of November 15, 2020.35,36, Long-acting injectable (LAI) antipsychotics with a longer duration of action are under development to improve adherence in patients with schizophrenia. Source: University of Manchester. Concerningly, 30% of people with schizophrenia do not respond to the lifelong antipsychotic medication prescribed to patients as reported by Dr. Helio Elkis in 2007 in his research paper “Treatment-Resistant Schizophrenia”. The APA recommends SGAs as first-line treatment of schizophrenia, excluding clozapine due to its AE profile.12 SGAs are preferred over FGAs because they are less often associated with extrapyramidal side effects (EPS), although SGAs are more often associated with metabolic AEs (eg, weight gain, hyperlipidemia, and diabetes mellitus).12 Combination therapy or treatment with clozapine is reserved for patients who have a partial or poor response to standard treatment with SGAs. After that point, all patients had the option to enter a six-month extension study where the drug was given to everyone. Clinical relevance of paliperidone palmitate 3-monthly in treating schizophrenia. Boter H, Peuskens J, Libiger J, et al; EUFEST study group. 0. 11-year follow-up of mortality in patients with schizophrenia: a population-based cohort study (FIN11 study). It has been investigated in acute or residual schizophrenia, bipolar depression, and other neurologic and psychiatric conditions.4 Lumateperone has a unique mechanism of action that targets 3 neurotransmitter pathways through modulation of dopamine D1 and D2 receptors and glutamate (NMDA) receptor subunit epsilon-2, also known as N-methyl D-aspartate receptor subtype 2B (GLuN2B), via downstream dopamine D1 receptors and through AMPA currents via the mTOR protein pathway.4,27,28, Lumateperone was investigated in two phase 3 randomized controlled trials in individuals with acute exacerbations of schizophrenia diagnosed via the Diagnostic and Statistical Manual of Mental Disorders, 5th edition criteria. Currently approved pharmacologic agents focus mainly on modulating dopamine, leaving patients with schizophrenia to cope with considerable residual symptoms. 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. Accessed November 20, 2019. Dr. Ken Duckworth is medical director of the National Alliance on Mental Illness. Jarskog LF, Hamer RM, Catellier DJ, et al; METS Investigators. Experts were hopeful that the findings, published April 16 in the New England Journal of Medicine, will lead to a new treatment option. This review summarizes the schizophrenia treatment guidelines, current treatment strategies, and emerging agents for the management of schizophrenia. This webinar will review the latest developments in NIMH-sponsored research including the recently announced Accelerating Medicines Partnership (AMP) Schizophrenia, a public-private partnership to advance the understanding of the risk factors for developing schizophrenia and promising new avenues for treatment… 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 approved new antipsychotic drug for treatment of schizophrenia: Caplyta (lumateperone). (In this case, "positive" means present.). Furthermore, significant antipsychotic efficacy was observed as early as week 1 with lumateperone 60 mg and maintained throughout the entire study. Symptoms may come and go, but schizophrenia requires lifelong treatment. Accessed November 22, 2019. Medical writing and editorial support: Brittany Hoffmann-Eubanks, PharmD, MBA. Presently, multiple agents are available for the treatment of schizophrenia; however, the majority do not address negative symptoms and cognitive dysfunction, with many patients having debilitating residual symptoms, difficulties with adherence, and drug-related adverse effects. Caplyta [prescribing information]. In this short-term trial, SEP-363856 eased both positive and negative symptoms. Treatment options for neurodevelopmental disorders like schizophrenia and autism are currently limited. Blocking D2 can lessen psychosis symptoms, but is also responsible for the drugs' most troublesome side effects. A new drug designed to treat acute psychosis in schizophrenic patients is reporting impressively positive results from a Phase 2 clinical trial. 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. These are designed to dampen the psychotic, or positive, symptoms of the illness. Accessed February 14, 2020. American Psychiatric Association website, Lieberman JA, Stroup TS, McEvoy JP, et al; Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Investigators. Eli Lilly’s LY2140023 appears to be the most advanced candidate in this class, with recruitment to a phase III trial under way. ... FDA Advisory Board In Favor of ALKS 3831 for Schizophrenia. Study to Evaluate Efficacy and Safety of Roluperidone (MIN-101) in Adult Patients With Negative Symptoms of Schizophrenia. Schizophrenia affects a small percentage of patients within the United States; however, its effect on physical function and QOL is significant. All rights reserved. Please post and discuss news, and videos, etc. A clinical psychologist is interested in evaluating the effectiveness of two new treatments for schizophrenia. Schizophrenia requires lifelong treatment, even when symptoms have subsided. That receptor helps modulate dopamine transmission. Schizophrenia. Treatment of tardive dyskinesia with VMAT-2 inhibitors: a systematic review and meta-analysis of randomized controlled trials. Treatment options for neurodevelopmental disorders like schizophrenia and autism are currently limited. ... Accessed February 14, 2020. In the double-blind phase, patients will receive either paliperidone every 3 months or paliperidone every 6 months. Read Time: New research into how a common parasite infection alters human behavior could assist the creation of treatments for schizophrenia and other neurological disorders. Dr Brannan is chief medical officer at Karuna Therapeutics and a neuroscience drug development expert. Revel FG, Moreau JL, Pouzet B, et al. Dixon L, Perkins D, Calmes C. Guideline watch (September 2009): practice guideline for the treatment of patients with schizophrenia. The guideline focuses on assessment and treatment planning, which are integral to … American Diabetes Association; American Psychiatric Association; American Association of Clinical Endocrinologists; North American Association for the Study of Obesity. Sunovion and PsychoGenics announce positive results from pivotal phase 2 study of novel investigational agent SEP-363856 for the treatment of schizophrenia. NEW YORK—A new psychotropic drug for treating adults with schizophrenia met its primary endpoint and was "generally well tolerated" in a phase 2a study, according to its developers, Sunovion Pharmaceuticals Inc. and PsychoGenics Inc. Credit: Plos.org. Emerging Evidence on Genetics of Schizophrenia Raises Hopes for New Treatment Targets Journal of Clinical Psychopharmacology Presents Translational Science Update . 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 20, 2019. 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. 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 … Blog / New Drug Approval for Treatment of Schizophrenia, Encouraging News! 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. Comparative efficacy and tolerability of 15 antipsychotic drugs in schizophrenia: a multiple-treatments meta-analysis [published correction appears in. Researchers found that, over one month, the drug helped manage the different ways in which schizophrenia manifests — from delusions and hallucinations, to flattened emotions and social withdrawal. December 14, 2020. A new set of evidence-based practice guidelines for the treatment of patients with schizophrenia has been released by the American Psychiatric Association, with the goal of reducing the significant consequences the disorder has on individuals. Please click "Next" if you did not attend this session. The trial involved 245 schizophrenia patients aged 18 to 40, all in the earlier course of the disease. People living with schizophrenia could benefit from new schizophrenia medications. 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. 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— Transdermal delivery systems may have benefits over other formulations, such as the ability to visually confirm medication adherence and possible improved tolerability. The oral pill from Intra-Cellular Therapies should be available in early 2020. "What's striking, to me," Koblan said, "is the efficacy against negative symptoms. 2020 | 15:14. It affects 0.6% to 1.9% of individuals within the United States, and currently there is no cure. 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. UPDATE ON SCHIZOPHRENIA: NEW TREATMENTS AND NOVEL TARGETS. Updated January 21, 2020. Efficacy and safety of MIN-101: a 12-week randomized, double-blind, placebo-controlled trial of a new drug in development for the treatment of negative symptoms in schizophrenia. If changing the antipsychotic drug is not possible, and lifestyle interventions are not effective, adding metformin to the patient’s medications may be helpful in reducing the metabolic effects, but limited data support its efficacy for this off-label indication.13,21, Prolactin levels can also become elevated as a result of treatment with antipsychotic medications. Espinoza S, Leo D, Sotnikova TD, Shahid M, Kääriäinen TM, Gainetdinov RR. Lehman AF, Lieberman JA, Dixon LB, et al; American Psychiatric Association; Steering Committee on Practice Guidelines. 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. WASHINGTON, D.C., Sept. 1, 2020 – The American Psychiatric Association (APA) today released a new evidence-based practice guideline to enhance the treatment of patients with schizophrenia… New Schizophrenia Treatment Guideline Released. Marlborough, MA, and Paramus, NJ: Sunovion Pharmaceuticals Inc and PsychoGenics Inc; September 27, 2019. news.sunovion.com/press-release/sunovion-and-psychogenics-initiate-diamond-phase-3-clinical-studies-sep-363856. Intra-Cellular Therapies announces top-line results from the second phase 3 trial of ITI-007 in patients with schizophrenia (Study ‘302) [news release]. Madrid, Spain: Laboratorios Farmacéuticos ROVI; March 19, 2019. edisongroup.com/publication/doria-phase-iii-trial-hits-primary-endpoint/23705. 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. clinicaltrials.gov/ct2/show/results/NCT02634346. Links will not be permitted. Sunovion and PsychoGenics initiate DIAMOND phase 3 clinical studies for SEP-363856 in the treatment of adults and adolescents with schizophrenia. Nov. 16, 2020 — New research into how a common parasite infection alters human behavior could help development of treatments for schizophrenia and other neurological disorders. Europe/London . Written by Kristen Fischer on October 22, … Kane JM, Agid O, Baldwin ML, et al. 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. Leucht S, Barnes TR, Kissling W, Engel RR, Correll C, Kane JM. 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. 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. New schizophrenia treatments address unmet clinical needs. The researchers found that there’s lower opioid receptor availability in people with schizophrenia, which could lead to new treatment pathways. Accessed November 20, 2019. He said, "I'm glad to see they're investing in a drug with a new mechanism of action. 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. Participants received either SEP-363856 (50 mg/day or 75 mg/day) or placebo. Johnson & Johnson. Schizophrenia is a complicated chronic disease affecting approximately 3.5 million people in the United States, and its annual healthcare costs exceed $155 billion. Marlborough, MA, and Paramus, NJ: Sunovion Pharmaceuticals Inc and PsychoGenics Inc; December 13, 2018. news.sunovion.com/press-release/sunovion-and-psychogenics-announce-positive-results-pivotal-phase-2-study-novel. Mathews M, Gopal S, Nuamah I, et al. Sunovion and PsychoGenics announce that SEP-363856 has received FDA Breakthrough Therapy designation for the treatment of people with schizophrenia. 5 days ago. Remington G. Tardive dyskinesia: eliminated, forgotten, or overshadowed? New York, NY: Intra-Cellular Therapies, Inc; September 16, 2015. ir.intracellulartherapies.com/news-releases/news-release-details/intra-cellular-therapies-announces-positive-top-line-results. All participants who completed the double-blind portion of ENLIGHTEN-1 were eligible to continue in an open-label, long-term safety, tolerability, and durability-of-effect study in which participants would receive olanzapine/samidorphan for an additional 12 months.33, ENLIGHTEN-2 was a multicenter, randomized, double-blind, phase 3 trial that evaluated the weight gain profile of olanzapine/samidorphan compared with olanzapine over 6 months in patients with stable schizophrenia.34 Participants with stable schizophrenia (n = 561) were randomized (1:1) to receive either olanzapine/samidorphan or olanzapine. Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of Schizophrenia (ADVANCE). © 2020 MJH Life Sciences™ and Clinical Care Targeted Communications, LLC. Hear details from the phase II trial of xanomeline-trospium and how it assists in the treatment of acute schizophrenia. However, a new treatment using the deep brain stimulation technique could improve the condition of patients. ENLIGHTEN-2 met both co-primary end points with patients in the olanzapine treatment group having a 57% higher mean percent weight change at 6 months compared with the olanzapine/samidorphan treatment group (6.59% olanzapine vs 4.21% olanzapine/samidorphan; P = .003).34,35 Also, patients in the olanzapine treatment group had nearly twice the risk of gaining 10% or more of their baseline body weight at 6 months compared with the olanzapine/samidorphan treatment group (29.8% olanzapine vs 17.8% olanzapine/samidorphan; P = .003).34 Similarly, patients in the olanzapine treatment group had approximately twice the risk of gaining 7% or more of their baseline body weight at 6 months compared with olanzapine/samidorphan (42.7% olanzapine vs 27.5% olanzapine/samidorphan; P = .001). He is chief scientific officer at Sunovion Pharmaceuticals in Marlborough, Massasachusetts, the company developing SEP-363856. One issue with existing medications is that side effects can make adherence difficult, Koblan said. Medication is currently the main method of treating schizophrenia, and the primary type of medication is a class of drugs called antipsychotics. The primary end point being studied is the change in Negative Symptom Assessment-16 (NSA-16) total score from baseline to week 26.41 Topline results of the study showed a statistically significant improvement in NSA-16 score as compared with placebo (—10.4 vs –8.5; P = .0043).42 Further results have not yet been published. While there is a laundry list of antipsychotic medications for schizophrenia, they are decades old. 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. Below is a review of the few new treatments that hit the shelves in 2020 and some investigational therapies that may be able to close the treatment gap for this population. Treatment with medications and psychosocial therapy can help manage the condition. New York, NY: Intra-Cellular Therapies, Inc; 2019. www.intracellulartherapies.com/docs/caplyta_pi.pdf. New York, NY: Intra-Cellular Therapies Inc; September 28, 2016. ir.intracellulartherapies.com/news-releases/news-release-details/intra-cellular-therapies-announces-top-line-results-second-phase. Second-generation versus first-generation antipsychotic drugs for schizophrenia: a meta-analysis. Am J Manag Care. Results showed that both the 75-mg and 100-mg once-monthly doses demonstrated statistically significant improvements (P <.0001) compared with placebo injections in the PANSS and CGI at 12 weeks.43 Complete results have not yet been published. Peluso MJ, Lewis SW, Barnes TR, Jones PB. AHA Scientific Sessions 2020 13 - 17 November 2020 Virtual Meeting Announcements; Meetings Calendar; Featured Newsrooms ... "We need to develop new treatments for schizophrenia. ACADIA Pharmaceuticals Announces Positive Top-line Results from ADVANCE Trial of Pimavanserin as Treatment for Negative Symptoms of Schizophrenia [news release]. Accessed November 23, 2019. 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. Due to the heterogeneity of clinical trial designs and lack of head-to-head comparisons, the draft guidelines do not offer an evidence-based list or algorithmic approach for antipsychotic selection. San Diego, CA: ACADIA Pharmaceuticals; November 25, 2019. ir.acadia-pharm.com/news-releases/news-release-details/acadia-pharmaceuticals-announces-positive-top-line-results?field_nir_news_date_value[min]=. Alkermes submits New Drug Application to U.S. Food and Drug Administration for ALKS 3831 for treatment of schizophrenia and bipolar I disorder [news release]. It's not fully clear how the drug works, according to Koblan, but it does act through a different mechanism than current antipsychotics. 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. Patel KR, Cherian J, Gohil K, Atkinson D. Schizophrenia: overview and treatment options. Updated February 7, 2020. 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 … Accessed February 25, 2020. To address these concerns, new research evaluating investigational therapies has been undertaken to examine novel treatment strategies. Updated June 27, 2018. Treatment with Methotrexate, a drug commonly prescribed for autoimmune disorders like R.A, produced positive effects against some prominent schizophrenia symptoms. The most common AEs reported for olanzapine/samidorphan were weight gain, somnolence, and dry mouth compared with olanzapine, which were weight gain, somnolence, and increased appetite. Share on Facebook. APA Releases New Practice Guideline on Treatment of Patients with Schizophrenia. Changes in the key secondary end point, CGI-S, were also statistically significant for both doses.25,26 The most commonly observed AEs were EPS, application-site reactions, and weight gain.25. No statistically significant changes emerged in EPS, body weight, lipids, glucose, or prolactin.29 The most common AEs were somnolence, with 17.3% versus 4.0% with lumateperone and placebo, respectively; mild sedation (12.0% vs 5.4%); and fatigue (5.3% vs 1.3%).29, The second phase 3 trial, ITI-007-302, was a multicenter, randomized, double-blind, fixed-dose, placebo- and active-controlled inpatient study conducted in 696 patients.30 Participants were randomized (1:1:1:1) to either lumateperone 60 or 20 mg, risperidone 4 mg as the active control, or placebo once daily in the morning for 6 weeks.27 Neither dose of lumateperone separated from placebo, whereas risperidone did. 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