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To evaluate the efficacy of Paliperidone Palmitate Injection in replacing oral antipsychotics for the treatment of schizophrenia and its impact on social function
This study plans to enroll 120 patients diagnosed with schizophrenia per DSM-5 criteria who have achieved clinical stability on oral antipsychotic therapy. Patients will receive monotherapy with Paliperidone Palmitate Injection. Assessments will be conducted at baseline, Day 35±7, Day 91±7, and Day 175±7. Adverse events and concomitant medications will be recorded during follow-up visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Switching from Oral Antipsychotics to Paliperidone Palmitate Injection in the Treatment of Schizophrenia Patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paliperidone Palmitate Injection (PP1M) | Drug | Day 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 175±7 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| electrocardiogram (ECG) | To analysis whether ECG QT Interval of participants show any significant trend with time changes. | Baseline, Day 35±7, Day 91±7, Day 175±7 |
| Alanine Aminotransferase (ALT) | To analysis whether ALT level of participants show any significant trend with time changes. |
Inclusion Criteria:
Exclusion Criteria:
9. Other conditions deemed unsuitable by the investigator. |
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hao Tang, MD | Contact | +86 18913821366 | tanghao997@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Brain Hospital | Nanjing | Jiangsu | 210024 | China |
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| Baseline, Day 35±7, Day 91±7, Day 175±7 |
| 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. | Baseline, Day 35±7, Day 91±7, Day 175±7 |
| 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. | Baseline, Day 35±7, Day 91±7, Day 175±7 |
| 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. | Baseline, Day 35±7, Day 91±7, Day 175±7 |
| Barnes Akathisia Rating Scale (BARS) | A structured scale measuring antipsychotic-induced akathisia (motor restlessness). Combines: Subjective distress (0-5) Objective movements (0-5) Global severity (0-5) Critical for differentiating akathisia from anxiety/agitation. | Baseline, Day 35±7, Day 91±7, Day 175±7 |
| Abnormal Involuntary Movement Scale (AIMS) | A 12-item observational tool screening tardive dyskinesia severity. Focuses on facial/oral, extremity, and truncal involuntary movements (rated 0-4 per item). Requires baseline/follow-up assessments for longitudinal monitoring. | Baseline, Day 35±7, Day 91±7, Day 175±7 |
| Baseline, Day 35±7, Day 91±7, Day 175±7 |
| Glucose (GLU) | To analysis whether GLU level of participants show any significant trend with time changes. | Baseline, Day 35±7, Day 91±7, Day 175±7 |
| Total Cholesterol (TC) | To analysis whether TC level of participants show any significant trend with time changes. | Baseline, Day 35±7, Day 91±7, Day 175±7 |
| High-Density Lipoprotein Cholesterol (HDL-C) | To analysis whether HDL-C level of participants show any significant trend with time changes. | Baseline, Day 35±7, Day 91±7, Day 175±7 |
| Low-Density Lipoprotein Cholesterol (LDL-C) | To analysis whether LDL-C level of participants show any significant trend with time changes. | Baseline, Day 35±7, Day 91±7, Day 175±7 |
| Triglycerides (TG) | To analysis whether TG level of participants show any significant trend with time changes. | Baseline, Day 35±7, Day 91±7, Day 175±7 |
| Prolactin (PRL) | To analysis whether PRL level of participants show any significant trend with time changes. | Baseline, Day 35±7, Day 91±7, Day 175±7 |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D012917 | Social Adjustment |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D012919 | Social Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000068882 | Paliperidone Palmitate |
| ID | Term |
|---|---|
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
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