To evaluate the efficacy of Paliperidone Palmitate Injection in replacing oral antipsychotics for the treatment of schizophrenia and its impact on social function
Outpatients or inpatients meeting DSM-5 diagnostic criteria forschizophrenia;
Aged 18-65 years (inclusive), regardless of gender;
Currently receiving first- or second-generation oral antipsychotics (excluding clozapine) with stable condition as assessed by the investigator, and PANSS total score ≤80 at screening and baseline;
Signed informed consent by the patient and/or guardian;
Comorbid psychiatric diagnoses other than schizophrenia;
Severe physical diseases, intellectual disability, organic brain disorders, or mental disorders due to physical illnesses;
QTc interval >450 ms (male) or >460 ms (female);
History of psychoactive substance abuse (excluding tobacco) within the past 12 months, or significant suicidal/violent tendencies;
Single group
Paliperidone Palmitate Injection (PP1M)
DrugDay 0: 150 mg deltoid injection; Day 7: 100 mg deltoid injection; Monthly maintenance dose of 75-150 mg (deltoid or gluteal) for 6 months (dose adjusted per investigator's judgment). To avoid missed doses, administration is permitted ±7 days around the scheduled monthly date.
The Positive and Negative Syndrome Scale (PANSS)
The Positive and Negative Syndrome Scale (PANSS) is a standardized clinical assessment tool used to evaluate the severity of symptoms in patients with schizophrenia. It measures three domains: Positive Symptoms (e.g., hallucinations, delusions), Negative Symptoms (e.g., social withdrawal, blunted affect), General Psychopathology (e.g., anxiety, guilt). Scores are derived from a 30-item structured interview, with each item rated on a 7-point scale (1=absent to 7=extreme). Higher total scores indicate more severe symptomatology. Widely used in research and clinical settings, PANSS helps monitor treatment efficacy and disease progression.
Personal and Social Performance (PSP)
The Personal and Social Performance (PSP) scale is a clinician-rated assessment tool designed to measure an individual's social and personal functioning across four key domains: socially useful activities (e.g., work/studies), personal/social relationships, self-care, and disruptive/aggressive behaviors. Scores range from 0 to 100, with higher values indicating better functional capacity. Widely used in mental health research and clinical practice, it provides a standardized way to evaluate functional impairment and recovery progress in conditions like schizophrenia.
EuroQol-5 Dimensions (EQ-5D)
The EQ-5D (EuroQol-5 Dimensions) is a standardized, self-reported questionnaire used to assess health-related quality of life. It evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated across three or five severity levels (depending on the version: EQ-5D-3L or EQ-5D-5L). Widely applied in health economics and clinical research, it aids in cost-effectiveness analyses and treatment outcome comparisons.
Clinical Global Impression-Severity (CGI-S)
A single-item, 7-point clinician rating (1=normal to 7=extremely severe) evaluating global psychiatric illness severity. Not diagnosis-specific, it provides rapid assessment of symptom intensity across mental disorders.
Extrapyramidal Symptom Rating Scale (SAS)
A clinician-administered tool assessing drug-induced movement disorders, including parkinsonism, dystonia, and akathisia. Rates 10 items (e.g., rigidity, tremor) on a 0-4 severity scale (total range 0-40). Widely used to monitor antipsychotic side effects.
electrocardiogram (ECG)
To analysis whether ECG QT Interval of participants show any significant trend with time changes.
Alanine Aminotransferase (ALT)
To analysis whether ALT level of participants show any significant trend with time changes.
Glucose (GLU)
To analysis whether GLU level of participants show any significant trend with time changes.
Total Cholesterol (TC)
To analysis whether TC level of participants show any significant trend with time changes.
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