Higher-dose paliperidone palmitate injection for adults with schizophrenia whose symptoms return early
Tests a higher paliperidone palmitate dose in adults with schizophrenia whose symptoms worsen early.
Plain-language title generated from the registry record
Registry title: Higher-Dose Maintenance With ERZOFRI 351 mg in Adults With Schizophrenia
Key facts
- Where
- Chicago, Miami, and Orange, United StatesSee the 3 sites
- Phase
- Phase 4
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with schizophrenia who get monthly paliperidone palmitate 234 mg but whose symptoms get worse before the next injection.
- Age
- 18 to 65 years
- Sex
- All sexes can join.
- Disease stage
- Schizophrenia (DSM-5 diagnosis) with symptom worsening, destabilization or decline in daily functioning before the next monthly injection in at least 2 of the last 3 cycles. Clinical Global Impression-Severity score from 3 (mildly ill) to 6 (severely ill).
- Earlier treatment
- Must have received paliperidone palmitate long-acting injection (INVEGA SUSTENNA or ERZOFRI) 234 mg every 4 weeks for at least 3 months in a row. Must have shown good tolerance of oral paliperidone or oral risperidone before.
Main reasons for not taking part
- Known allergy to paliperidone, risperidone or ERZOFRI ingredients
- Kidney problems (creatinine clearance below 50 mL/min)
- Severe substance use disorder in the past 6 months
- Pregnant or breastfeeding women
- Using strong CYP3A4 or P-gp inducers such as carbamazepine, rifampin or St. John's Wort
Read by machine on 11 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07927946, who can take part
Where in United States
- Pillar Clinical ResearchChicago, United StatesNo longer taking part
- Passageway Residences of Dade CountyMiami, United StatesNo longer taking part
- ATP Clinical ResearchOrange, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Alejandro Alva
- Trial code
- NCT07927946
- Record updated
- 10 November 2026
- Original description
This is a prospective, multicenter, open-label, single-arm study evaluating ERZOFRI (paliperidone palmitate) 351 mg administered every 4 weeks as maintenance treatment in approximately 40 adults with schizophrenia who experience symptom worsening before their next scheduled monthly injection despite receiving paliperidone palmitate 234 mg every 4 weeks.Read full original descriptionShow less
Exploratory Evaluation of ERZOFRI (Paliperidone Palmitate) 351 mg Q4W Maintenance in Higher-Need Patients With Schizophrenia: Clinical Global Improvement, Drug-Induced Parkinsonism, and Sexual Dysfunction Outcomes Over a 3-Month Treatment Period
This is a prospective, multicenter, open-label, single-arm study evaluating ERZOFRI (paliperidone palmitate) 351 mg administered every 4 weeks as maintenance treatment in approximately 40 adults with schizophrenia who experience symptom worsening before their next scheduled monthly injection despite receiving paliperidone palmitate 234 mg every 4 weeks.
Participants will receive ERZOFRI 351 mg on Day 1, Week 4, and Week 8 and will complete an end-of-study assessment at Week 12. The study will evaluate changes in clinical severity over 12 weeks and will also assess movement-related side effects and sexual functioning.
Inclusion: 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.
Exclusion: 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.