Higher-Dose Maintenance With ERZOFRI 351 mg in Adults With Schizophrenia

Ki vehet részt

• Adults aged 18-65 years with a DSM-5 diagnosis of schizophrenia
• Currently receiving monthly paliperidone palmitate long-acting injectable (INVEGA SUSTENNA or ERZOFRI) at a dose of 234 mg every 4 weeks (Q4W) for at least 3 consecutive months before Screening
• Clinician-documented symptom breakthrough, destabilization, or functional deterioration occurring before the scheduled 4-week injection interval during at least 2 of the 3 most recent monthly injection cycles (not necessarily consecutive). Documentation may include progress notes indicating symptom worsening in the final week before the next injection, unscheduled clinic or emergency department visits for psychiatric symptoms, as-needed medication use for breakthrough psychosis, or clinician judgment based on longitudinal care
• Documented prior tolerability to oral paliperidone or oral risperidone
• Clinical Global Impression-Severity (CGI-S) score ≥3 (mildly ill) and ≤6 (severely ill) at Baseline
• Able and willing to independently provide written informed consent

Ki nem vehet részt

• Known hypersensitivity to paliperidone, risperidone, or any ERZOFRI formulation excipient
• Other clinically significant electrocardiogram abnormalities, including serious ventricular arrhythmias, clinically significant conduction abnormalities, or evidence of unstable cardiovascular disease, as determined by the investigator
• Other metabolic abnormalities or medical conditions that, in the investigator's judgment, represent active, uncontrolled disease that could compromise participant safety or suitability for study participation
• Severe substance use disorder within the past 6 months, according to DSM-5 criteria
• History of neuroleptic malignant syndrome (NMS) or tardive dyskinesia (TD) requiring treatment discontinuation
• Renal impairment, defined as creatinine clearance (CrCl) <50 mL/min
• Hemoglobin A1c (HbA1c) ≥7.0% at Screening
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2 times the upper limit of normal (ULN) at Screening
• QT interval corrected using Fridericia's formula (QTcF) >450 milliseconds (ms) for males or >470 ms for females at Screening. A QTcF ≥480 ms is exclusionary regardless of sex
• Body mass index (BMI) >43 kg/m² at Screening
• Current or recent (within the past 30 days) participation in another interventional clinical trial
• Pregnant or breastfeeding women, or women of childbearing potential who are unwilling or unable to comply with protocol-specified contraception requirements throughout study participation and for 45 days following the final study injection
• Current use of strong CYP3A4 and/or P-glycoprotein (P-gp) inducers, including carbamazepine, rifampin, or St. John's Wort
• Imminent risk of harm to self or others, as assessed by the investigator