Summary: Schizophrenia may, in part, be caused by immune system dysfunction, a new study reports. Non-neurological and metabolic side effects in the Cost Utility of the Latest Antipsychotics in Schizophrenia randomised controlled trial (CUtLASS-1). While those drugs are numerous, Goff said, they all work in a similar manner — by blocking a receptor on brain cells called D2, which interacts with the chemical dopamine. McClellan J, Sikich L, Findling RL, et al. 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 … 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. Dixon L, Perkins D, Calmes C. Guideline watch (September 2009): practice guideline for the treatment of patients with schizophrenia. Schizophrenia requires lifelong treatment, even when symptoms have subsided. Among 120 patients who took the drug, 65% were responding by week four. Leucht S, Cipriani A, Spineli L, et al. Dr Brannan is chief medical officer at Karuna Therapeutics and a neuroscience drug development expert. From long-lasting Injectables to a whole new drug class, here are the five most important cutting-edge treatments. And for the millions of people worldwide with the mental illness, there is still a critical "unmet medical need," said study author Kenneth Koblan. The treatment team also may include a psychologist, social worker, psychiatric nurse and … 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. American Journal of Psychiatry. UPDATE ON SCHIZOPHRENIA: NEW TREATMENTS AND NOVEL TARGETS. Antipsychotics used to treat schizophrenia are not effective for all patients, do not … Accessed November 20, 2019. clinicaltrials.gov/ct2/show/results/NCT02634346. © 2020 MJH Life Sciences and AJMC. Guidelines recommend a combined treatment approach with both pharmacologic agents and psychological interventions for first-episode psychosis, acute exacerbations, and relapse prevention. Further, decision making regarding choice of treatment should include the patient whenever possible. Updated November 27, 2019. NOV 20, 2020 7:30 AM PST. Symptoms may come and go, but schizophrenia requires lifelong treatment. ", Goff, who wrote an editorial published with the study, agreed the initial results are "very encouraging. sardaa.org/resources/about-schizophrenia/. Cautious, he said, because this was a short-term trial. 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]=. Approximately 10% to 30% of individuals with schizophrenia experience a limited benefit from antipsychotic treatment.13 Moreover, some studies have shown that 30% of individuals with schizophrenia experience improvement but still have some persistent psychotic or residual symptoms that affect their functioning and QOL.14 Furthermore, acute treatment of schizophrenia is complicated by the delay between initiation of treatment and therapeutic response. 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. Genetic Associations May Lead to New Treatments for Schizophrenia. Keeping up with the therapeutic advances in schizophrenia: a review of novel and emerging pharmacological entities. Accessed February 7, 2020. 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. Research into the treatment of schizophrenia is long overdue, as it can be a devastating disease process. Novel Pharmacological Treatment for Ameliorating Adverse Events. Schizophrenia is a chronic neuropsychiatric disorder that has a significant impact on the functioning and quality of life of individuals affected by the disease. Accessed February 14, 2020. 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. 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). Dublin, Ireland: Alkermes; June 29, 2017. businesswire.com/news/home/20170629006201/en/Alkermes-Announces-Positive-Preliminary-Topline-Results-Phase. Updated January 21, 2020. Accessed November, 20 2019. Instead it stimulates a different brain receptor, called TAAR1. 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%. 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]. 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). 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. Sunovion and PsychoGenics announce that SEP-363856 has received FDA Breakthrough Therapy designation for the treatment of people with schizophrenia. 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. Sun L, McDonnell D, von Moltke L. Pharmacokinetics and short-term safety of ALKS 3831, a fixed-dose combination of olanzapine and samidorphan, in adult subjects with schizophrenia. T.gondii parasites. The drugs work well against positive symptoms in about 70% of patients, said Dr. Donald Goff, a professor of psychiatry at New York University School of Medicine, in New York City. 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/. Experts were hopeful that the findings, published April 16 in the New England Journal of Medicine, will lead to a new treatment option. Schizophrenia is … A new drug designed to treat acute psychosis in schizophrenic patients is reporting impressively positive results from a Phase 2 clinical trial. Written by Kristen Fischer on October 22, … Blog / New Drug Approval for Treatment of Schizophrenia, Encouraging News! Older, "first-generation" drugs can cause movement impairments similar to those seen in Parkinson's disease — tremors, joint stiffness and coordination problems. 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. Am J Manag Care. While there is a laundry list of antipsychotic medications for schizophrenia, they are decades old. 136. 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. 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. Safety was also evaluated in ENLIGHTEN-2; overall, 62.4% of olanzapine/samidorphan participants completed the study compared with 63.8% of olanzapine participants. 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. A clinical psychologist is interested in evaluating the effectiveness of two new treatments for schizophrenia. After that point, all patients had the option to enter a six-month extension study where the drug was given to everyone. Solmi M, Pigato G, Kane JM, Correll CU. Janssen Submits Paliperidone Palmitate 6-Month (PP6M) Supplemental New Drug Application to US FDA for Treatment of Schizophrenia in Adults. Kahn RS, Sommer IE, Murray RM, et al. 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. And taking the … Sunovion and PsychoGenics initiate DIAMOND phase 3 clinical studies for SEP-363856 in the treatment of adults and adolescents with schizophrenia. 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. APA Releases New Practice Guideline on Treatment of Patients with Schizophrenia. The American Psychiatric Association (APA) has released a new evidence-based practice guideline for the treatment of schizophrenia. Accessed November 20, 2019. Symptoms of hallucinations and delusions mark this mental disorder, changing the lives of patients and their families. Approximately 30% of individuals with schizophrenia are considered resistant to currently available drug therapies. Funding source: This activity is supported by an educational grant from Alkermes, Inc. Relapse prevention in schizophrenia with new-generation antipsychotics: a systematic review and exploratory meta-analysis of randomized, controlled trials. Links will not be permitted. 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. Neurons are responsible for receiving information from the outside world and conveying this information to the rest of our body. Janssen Pharmaceutical Companies of Johnson & Johnson announced their supplemental New Drug Application (sNDA) submission for paliperidone palmitate 6-month (PP6M). … There are currently no FDA-approved drugs to treat the core symptoms of autism. 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. A study by clinical scientists at The University of … Roluperidone is a cyclic amide derivative developed to target the negative symptoms of and cognitive dysfunction in schizophrenia. Hear details from the phase II trial of xanomeline-trospium and how it assists in the treatment of acute schizophrenia… About half were randomly assigned to take SEP-363856 capsules once a day, while the rest received placebo capsules. The first medications for schizophrenia were discovered serendipitously in the 1950s, with subsequent “me-too” drugs targeting the same limited number of neurotransmitters. 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. 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. 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. AHA Scientific Sessions 2020 13 - 17 November 2020 Virtual Meeting Announcements; Meetings Calendar; Featured Newsrooms ... "We need to develop new treatments for schizophrenia. clinicaltrials.gov/ct2/show/NCT02694328. Overall, the effectiveness was maintained, Koblan said. 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. If … Vanover K, Dmitrienko A, Glass S, et al. People living with schizophrenia could benefit from new schizophrenia medications. It affects 0.6% to 1.9% of individuals within the United States, and currently there is no cure. Share on Pinterest . Keefe RSE, Harvey PD, Khan A, et al. U.S. FDA approves Secuado (asenapine) transdermal system, the first-and-only transdermal patch for the treatment of adults with schizophrenia [news release]. Treatment with Methotrexate, a drug commonly prescribed for autoimmune disorders like R.A, produced positive effects against some prominent schizophrenia symptoms. Drug-induced parkinsonism may also be experienced by patients and can manifest as tremors, rigidity, impaired gait, and psychomotor retardation. Credit: Plos.org. Leucht S, Corves C, Arbter D, Engel RR, Li C, Davis JM. Efficacy of Lu AF35700 in Patients with Early-in-disease or Late-in-disease Treatment-resistant Schizophrenia (Anew). 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 … 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. 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. Accessed November 22, 2019. Response to pharmacologic therapy varies widely among patients with schizophrenia, with many having a poor or partial response. Comparative efficacy and tolerability of 15 antipsychotic drugs in schizophrenia: a multiple-treatments meta-analysis [published correction appears in. Alkermes announces positive preliminary topline results from phase 3 antipsychotic efficacy study of ALKS 3831 for treatment of schizophrenia [news release]. 1 While some of these therapies may help treat the negative and cognitive symptoms of schizophrenia, a few are associated with QTc interval prolongation. Espinoza S, Leo D, Sotnikova TD, Shahid M, Kääriäinen TM, Gainetdinov RR. 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/NCT03230864. Schizophrenia and Related Disorders Alliance of America website. Citrome L, Zeni CM, Correll CU. It's not fully clear how the drug works, according to Koblan, but it does act through a different mechanism than current antipsychotics. Transdermal delivery systems may have benefits over other formulations, such as the ability to visually confirm medication adherence and possible improved tolerability. Includes information about psychosis and a psychotic episode. Fellner C. New schizophrenia treatments address unmet clinical needs. SEP-363856 met its primary end point with a statistically significant and clinically meaningful improvement in the PANSS compared with placebo at week 4 (—17.2 vs –9.7; P = .001; effect size, 0.45). Effectiveness of antipsychotics in first-episode schizophrenia and schizophreniform disorder on response and remission: an open randomized clinical trial (EUFEST). Dr. Ken Duckworth is medical director of the National Alliance on Mental Illness. 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. Medication is currently the main method of treating schizophrenia, and the primary type of medication is a class of drugs called antipsychotics. Learning Objectives • Review clinical advances in our understanding of schizophrenia • Update knowledge on novel treatments for schizophrenia. Source: University of Manchester. Trace amine-associated receptor 1: a multimodal therapeutic target for neuropsychiatric diseases. 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. Davidson M, Saoud J, Staner C, et al. 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. PANSS Total Score Change from Baseline … However, a new treatment using the deep brain stimulation technique could improve the condition of patients. A larger trial of the drug is underway. clinicaltrials.gov/ct2/show/NCT02970305. That compared with 44% of patients given a placebo. 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. If it proves safe and effective, Goff said that one future question will be whether it can help people who have failed to respond to standard antipsychotics. Schwartz MD, Canales JJ, Zucchi R, Espinoza S, Sukhanov I, Gainetdinov RR. Dr Brannan is chief medical officer at Karuna Therapeutics and a neuroscience drug development expert. 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. As patients with schizophrenia often have attentional and cognitive impairments during acute exacerbations, it is important for healthcare professionals to revisit target symptoms and unwanted AEs from drug treatment on multiple occasions to adjust treatment over time.12 The final version of the updated practice guidelines is expected to be released in summer 2020. This may be done to help rule out other problems that could be causing symptoms and to check for any related complications. 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. And I'm cautiously optimistic about it.". Medical writing and editorial support: Brittany Hoffmann-Eubanks, PharmD, MBA. Clinical guidance on the identification and management of treatment-resistant schizophrenia. Please click "Next" if you did not attend this session. Accessed November 12, 2020. American Psychiatric Association website, Lieberman JA, Stroup TS, McEvoy JP, et al; Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Investigators. acmigold15; October 11, 2020 ; Blog; 0 ... Research into the treatment of schizophrenia is long overdue, as it can be a devastating disease process. 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. Suboptimal treatment, significant AEs, and challenges related to nonadherence create a need for new agents to better manage schizophrenia. 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. The most common AEs (≥5%) were headache, somnolence, and insomnia. 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. Participants received either SEP-363856 (50 mg/day or 75 mg/day) or placebo. Diagnosis of schizophrenia involves ruling out other mental health disorders and determining that symptoms are not due to substance abuse, medication or a medical condition. And because many of the traditional medications used to treat the disorder cause major side effects, those with schizophrenia … News Nov 17, 2020 | Original story from the University of Leeds . New Schizophrenia Treatment Guideline Released. 5 days ago. About schizophrenia. 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. 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. Just 1% of patients in each arm reported serious AEs, and discontinuation was low at 2.5% for pimavanserin and 0% for placebo. 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. Similarly, drug-induced dystonia presents with involuntary muscle contractions that result in contorted positions of body parts such as the neck, jaw, or arms.13 To alleviate acute EPS, healthcare professionals can decrease the dose of antipsychotic medication or switch to an alternative agent with fewer EPS. 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 14, 2020. The guideline focuses on assessment and treatment planning, which are integral to … 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. One issue with existing medications is that side effects can make adherence difficult, Koblan said. American Diabetes Association; American Psychiatric Association; American Association of Clinical Endocrinologists; North American Association for the Study of Obesity. I was pleasantly surprised to read this article stating the FDA approval for a new drug trial for schizophrenia. 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. Learn more about Schizophrenia causes, symptoms, resources, and treatment from Psych Central. To address these concerns, new research evaluating investigational therapies has been undertaken to examine novel treatment strategies. Treatment with medications and psychosocial therapy can help manage the condition. 2,3 Adherence with (limited) treatment options for this patient population are suboptimal. (In this case, "positive" means present.). Biochemical and functional characterization of the trace amine-associated receptor 1 (TAAR1) agonist RO5263397. Cognitive effects of MIN-101 in patients with schizophrenia and negative symptoms: results from a randomized controlled trial. CPFT joins international research partnership to find new treatments for schizophrenia. Metformin for weight loss and metabolic control in overweight outpatients with schizophrenia and schizoaffective disorder. 2020 | 15:14. 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. Finding New Treatments for Schizophrenia 2020 APA Scientific Conference 50% of survey complete. A Study of ALKS 3831 in Adults With Acute Exacerbation of Schizophrenia (the ENLIGHTEN-1 Study). Accessed November 22, 2019. Hear details from the phase II trial of xanomeline-trospium and how it assists in the treatment of acute schizophrenia. Emerging Evidence on Genetics of Schizophrenia Raises Hopes for New Treatment Targets Journal of Clinical Psychopharmacology Presents Translational Science Update . 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… Physical exam. 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. That receptor helps modulate dopamine transmission. Second-generation versus first-generation antipsychotic drugs for schizophrenia: a meta-analysis. Accessed February 18, 2020. 28, 2020 . 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. 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. 0. Schizophrenia is a complicated chronic disease affecting approximately 3.5 million people in the United States, and its annual healthcare costs exceed $155 billion. 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). The agent is an antagonist of σ-2 and 5-HT2A and has a low affinity for dopaminergic, muscarinic, cholinergic, and histaminergic receptors.44,45 A phase 3, randomized, double-blind, placebo-controlled, parallel-group trial evaluating the efficacy and safety of roluperidone in 501 adult patients with negative symptoms of schizophrenia is currently underway.46 The primary objective is to evaluate the efficacy of 32 mg/day and 64 mg/day of roluperidone compared with placebo over 12 weeks via change in PANSS Marder negative symptoms factor score. Krogmann A, Peters L, von Hardenberg L, Bödeker K, Nöhles VB, Correll CU. Symptoms may come and go, but schizophrenia requires lifelong treatment. 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. Schizophrenia affects a small percentage of patients within the United States; however, its effect on physical function and QOL is significant. 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. The experimental drug, in contrast, leaves D2 alone. Blocking D2 can lessen psychosis symptoms, but is also responsible for the drugs' most troublesome side effects. And that, they argue, warrants further investigation. And because many of the traditional medications used to treat the disorder cause major side effects, those with schizophrenia can be reluctant to take them. clinicaltrials.gov/ct2/show/NCT03397134. 2020;26:S55-S61. Secondary Source New England Journal of Medicine 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. All rights reserved. Accessed February 14, 2020. Japan Saga Tosu: Hisamitsu Pharmaceutical Co. Inc; 2019. www.noven.com/SECUADO_USPI.pdf. 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. ISM allows for therapeutic blood levels of LAI antipsychotic to be achieved without coadministration of initial oral antipsychotics, loading doses, or booster injections, potentially improving adherence.4 Topline results for PRISMA-3, a phase 3, multicenter, randomized, placebo-controlled study of risperidone ISM, were recently released.43 This study evaluated once-monthly intramuscular risperidone ISM in 438 patients with acutely exacerbated schizophrenia. Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of Schizophrenia (ADVANCE). FDA approved new antipsychotic drug for treatment of schizophrenia: Caplyta (lumateperone). 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. Share on LinkedIn. Patel KR, Cherian J, Gohil K, Atkinson D. Schizophrenia: overview and treatment options. Updated June 27, 2018. Tests and screenings. Treatment. In some cases, hospitalization may be needed. News release. 2. Agonists of the TAAR-1 receptor include amphetamine and methamphetamine. November 2, 2020. Mathews M, Gopal S, Nuamah I, et al. Please post and discuss news, and videos, etc. Accessed November 20, 2019. Secuado [prescribing information]. The oral pill from Intra-Cellular Therapies should be available in early 2020. Tiihonen J, Lönnqvist J, Wahlbeck K, et al. 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. Jarskog LF, Hamer RM, Catellier DJ, et al; METS Investigators. 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. The drug — dubbed SEP-363856 — also appeared to avoid the side effects common with standard antipsychotic medications. APA Releases New Practice Guideline on Treatment of Patients with Schizophrenia. Treatment options for neurodevelopmental disorders like schizophrenia and autism are currently limited. 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. Revel FG, Moreau JL, Pouzet B, et al. The primary end point was a change in PANSS total score from baseline to week 6. A Study of ALKS 3831 in Adults With Schizophrenia (The ENLIGHTEN-2 Study). Significant side effects did not show up, but those issues can take time to manifest, Duckworth noted. American. Eli Lilly’s LY2140023 appears to be the most advanced candidate in this class, with recruitment to a phase III trial under way. THURSDAY, April 16, 2020 (HealthDay News) -- An experimental drug may ease a range of symptoms that strike people with schizophrenia, without the side effects of existing medications, an … ... FDA Advisory Board In Favor of ALKS 3831 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. 2020. doi: 10.1176/appi.ajp.2020.19121279. Madrid, Spain: Laboratorios Farmacéuticos ROVI; March 19, 2019. edisongroup.com/publication/doria-phase-iii-trial-hits-primary-endpoint/23705. These are designed to dampen the psychotic, or positive, symptoms of the illness. The trial involved 245 schizophrenia patients aged 18 to 40, all in the earlier course of the disease. Accessed November 24, 2019. 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. Share on Facebook. Furthermore, patients with comorbid AUD are often excluded from pharmacologic trials in schizophrenia. Practice guideline for the treatment of patients with schizophrenia, second edition. October 9, 2020. 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. 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]. Study to Evaluate Efficacy and Safety of Roluperidone (MIN-101) in Adult Patients With Negative Symptoms of 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. Accessed February 7, 2020. Johnson & Johnson. Accessed November 24, 2019. New York, NY: Intra-Cellular Therapies, Inc; 2019. www.intracellulartherapies.com/docs/caplyta_pi.pdf. Accessed February 25, 2020. Accessed February 24, 2020. Alkermes announces positive topline results from ENLIGHTEN-2 phase 3 study of ALKS 3831 in patients with schizophrenia [news release]. Accessed November 23, 2019. 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]. 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— Determining a diagnosis of schizophrenia may include: 1. Address correspondence to: mmaroney@pharmacy.rutgers.edu. 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… However, a new treatment using the deep brain stimulation technique could improve the condition of patients. -30-25-20-15-10-5. clinicaltrials.gov/ct2/show/NCT02970292. Keep discussions on topic, avoid personal attacks and threats of any kind. Lumateperone (ITI-007) for the treatment of schizophrenia: placebo-controlled clinical trials and an open-label safety switching study. Share on Twitter. 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. 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. Schizophrenia is a severe disease that affects 1% of the worldwide population and reliable, effective treatments are almost nonexistent. Read Newsmax Terms and Conditions of Service. 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. 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). 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 F17464 (20 mg twice daily) versus placebo treatment for 6 weeks in adult patients with acute exacerbation of schizophrenia. Accessed December 26, 2019. 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. Remington G. Tardive dyskinesia: eliminated, forgotten, or overshadowed? 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. While there is a laundry list of antipsychotic medications for schizophrenia… 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 … 11-year follow-up of mortality in patients with schizophrenia: a population-based cohort study (FIN11 study). "Negative" refers to what's lost, and the symptoms include flattened emotions, difficulty feeling pleasure and withdrawal from others. ACADIA Pharmaceuticals announces top-line results from phase 3 ENHANCE trial of pimavanserin as adjunctive treatment for patients with schizophrenia [news release]. Beyond that, existing medications only address one group of schizophrenia symptoms — the hallucinations, delusions and confused thoughts that doctors call "positive" symptoms. Also, no statistically significant differences in vital signs, weight, metabolic profile, or EPS emerged, compared with placebo. The information presented on this website is not intended as specific medical advice and is not a substitute for professional medical treatment or diagnosis. Currently approved pharmacologic agents focus mainly on modulating dopamine, leaving patients with schizophrenia to cope with considerable residual symptoms. Pimavanserin was investigated in the phase 3 ENHANCE trial as an adjunct to antipsychotic treatment in patients with residual positive symptoms.39 The addition of pimavanserin showed a consistent trend of improving psychotic symptoms; however, the results for the primary end point, change in PANSS total score from baseline, did not achieve statistical significance (P = .0940). 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. Patches: established and emerging transdermal treatments in psychiatry. A Managed Care Review of Schizophrenia: Evaluating Unmet Medical Needs, New Treatments, and Health Economics, Honoraria: American Physician Institute, Specialty Pharma Education Center, PlatformQ Health, Lecture fees: Otsuka Pharmaceutical speakers bureau, American Society of Health-System Pharmacists, Meeting/conference attendance: College of Psychiatric and Neurologic Pharmacists, American Society of Health-System Pharmacists. 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. But, Goff said, they do not ease the "negative" symptoms that plague people with schizophrenia. on the latest developments in schizophrenia research, treatments, and related issues. 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