{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T15:47:37Z","timestamp":1782920857049,"version":"3.54.5"},"reference-count":41,"publisher":"American Medical Association (AMA)","issue":"7","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Psychiatry"],"published-print":{"date-parts":[[2026,7,1]]},"abstract":"\n Importance<\/jats:title>\n \n LB-102 (\n N<\/jats:italic>\n -methyl amisulpride) is a novel benzamide under investigation for the treatment of schizophrenia.\n <\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To evaluate the efficacy and safety of LB-102 in acute schizophrenia.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n \n This US-based, multicenter, double-blind, placebo-controlled, phase 2 randomized clinical trial (NOVA\n 1<\/jats:sup>\n ) conducted from December 2023 to August 2024 comprised an inpatient screening period (\u226414 days), 28-day inpatient treatment period, 5-day inpatient stabilization period, and outpatient safety follow-up visit\u2009approximately\u20092 weeks after the treatment period end. Eligible participants were adults (aged 18-55 years) with schizophrenia who required hospitalization or continued hospitalization for an acute exacerbation of psychotic symptoms and had a Positive and Negative Syndrome Scale (PANSS) total score of 80 to 120, PANSS Positive Symptoms subscale item score of 4 or greater on 2 or more key items, and a Clinical Global Impressions\u2013Severity of Illness scale (CGI-S) score of 4 or greater at screening and baseline.\n <\/jats:p>\n <\/jats:sec>\n \n Interventions<\/jats:title>\n Participants were randomized (3:3:3:1) to oral once-daily placebo, LB-102 50 mg, 75 mg, or 100 mg.<\/jats:p>\n <\/jats:sec>\n \n Main outcomes and Measures<\/jats:title>\n The primary end point was change from baseline to week 4 in PANSS total score (Hochberg multiplicity correction for LB-102 50 mg and 75 mg vs placebo). Secondary efficacy end points included changes from baseline to week 4 in CGI-S score, CGI-S response, PANSS subscale scores, PANSS Marder factor scores, and 20% or greater PANSS response. Safety and tolerability end points included treatment-emergent adverse effects (TEAEs).<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n A total of 359 participants (mean [SD] age, 39.1 [9.3] years; 290 male [80.8%]; mean baseline PANSS total score =\u2009approximately\u200994 across groups) were randomized and included in the safety and intention-to-treat populations (placebo, n\u2009=\u2009108; 50 mg, n\u2009=\u2009107; 75 mg, n\u2009=\u2009108; 100 mg, n\u2009=\u200936). The trial met the primary end point: LB-102 50 mg and 75 mg, were statistically superior to placebo in change from baseline to week 4 in PANSS total score (mean [SE], placebo, \u22129.3 [1.08]; 50 mg, \u221214.3 [1.10],\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001; Hedges\n g<\/jats:italic>\n \u2009=\u20090.61; 75 mg, \u221214.0 [1.11],\n P<\/jats:italic>\n \u2009=\u2009.002; Hedges\n g<\/jats:italic>\n \u2009=\u20090.41); LB-102 100 mg, also showed significance (mean [SE], \u221216.1 [1.91]; nominal\n P<\/jats:italic>\n \u2009=\u2009.002; Hedges\n g<\/jats:italic>\n \u2009=\u20090.83). TEAEs were reported in 60 participants (56%) in the placebo group, 74 (69%) in the group receiving 50 mg, 62 (57%) in the group receiving 75 mg, and 27 (75%) in the group receiving 100 mg. Ten participants reported TEAEs leading to withdrawal (placebo, n\u2009=\u20092; 50 mg, n\u2009=\u20092; 75 mg, n\u2009=\u20093; 100 mg, n\u2009=\u20093) with 5 serious TEAEs (placebo, n\u2009=\u20092 [including 1 death]; each LB-102 arm, n\u2009=\u20091).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n This randomized clinical trial provided rigorous evidence demonstrating the efficacy and safety of LB-102 for the treatment of adults with acute schizophrenia.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n ClinicalTrials.gov Identifier:\n NCT06179108<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamapsychiatry.2026.0428","type":"journal-article","created":{"date-parts":[[2026,4,22]],"date-time":"2026-04-22T15:30:25Z","timestamp":1776871825000},"page":"682","source":"Crossref","is-referenced-by-count":0,"title":["Antipsychotic Efficacy and Safety of LB-102 in the Treatment of Adults With Acute 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California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rishi","family":"Kakar","sequence":"additional","affiliation":[{"name":"Segal Trials, Lauderhill, Florida"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Niccolo","family":"Bassani","sequence":"additional","affiliation":[{"name":"Worldwide Clinical Trials, Nottingham, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leslie","family":"Callahan","sequence":"additional","affiliation":[{"name":"LB Pharmaceuticals Inc, New York, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Baker P.","family":"Lee","sequence":"additional","affiliation":[{"name":"LB Pharmaceuticals Inc, New York, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zachary","family":"Prensky","sequence":"additional","affiliation":[{"name":"LB Pharmaceuticals Inc, New York, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew 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