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. on the latest developments in schizophrenia research, treatments, and related issues. In the double-blind phase, patients will receive either paliperidone every 3 months or paliperidone every 6 months. 2020. doi: 10.1176/appi.ajp.2020.19121279. Experts were hopeful that the findings, published April 16 in the New England Journal of Medicine, will lead to a new treatment option. 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). 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. Updated February 10, 2020. Accessed November 22, 2019. A psychiatrist experienced in treating schizophrenia usually guides treatment. Accessed February 18, 2020. 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). 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. In some cases, hospitalization may be needed. 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). A clinical psychologist is interested in evaluating the effectiveness of two new treatments for schizophrenia. Clinical guidance on the identification and management of treatment-resistant schizophrenia. UPDATE ON SCHIZOPHRENIA: NEW TREATMENTS AND NOVEL TARGETS. A larger trial of the drug is underway. 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. Dr Brannan is chief medical officer at Karuna Therapeutics and a neuroscience drug development expert. 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]. 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. 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. 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