Schizophrenia
Conditions
Keywords
Schizophrenia, Paliperidone Palmitate, Oral antipsychotics, Social function|
Brief summary
To evaluate the efficacy of Paliperidone Palmitate Injection in replacing oral antipsychotics for the treatment of schizophrenia and its impact on social function
Detailed description
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.
Interventions
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.
Sponsors
Jiangsu Province Nanjing Brain Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Outpatients or inpatients meeting DSM-5 diagnostic criteria forschizophrenia; 2. Aged 18-65 years (inclusive), regardless of gender; 3. 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; 4. Signed informed consent by the patient and/or guardian;
Exclusion criteria
1. Comorbid psychiatric diagnoses other than schizophrenia; 2. Severe physical diseases, intellectual disability, organic brain disorders, or mental disorders due to physical illnesses; 3. QTc interval \>450 ms (male) or \>460 ms (female); 4. History of psychoactive substance abuse (excluding tobacco) within the past 12 months, or significant suicidal/violent tendencies; 5. Current or history of tardive dyskinesia (TD), neuroleptic malignant syndrome (NMS), or severe extrapyramidal symptoms (EPS); 6. Treatment-resistant schizophrenia (failure of ≥2 adequate antipsychotic regimens of different compounds); 7. Hypersensitivity or inefficacy to risperidone or paliperidone; 8. Pregnancy, lactation, planned pregnancy, or failure to use effective contraception during the study; 9\. Other conditions deemed unsuitable by the investigator. \|
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Positive and Negative Syndrome Scale (PANSS) | Day 175±7 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EuroQol-5 Dimensions (EQ-5D) | Baseline, Day 35±7, Day 91±7, Day 175±7 | 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) | Baseline, Day 35±7, Day 91±7, Day 175±7 | 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. |
| Personal and Social Performance (PSP) | Baseline, Day 35±7, Day 91±7, Day 175±7 | 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. |
| Barnes Akathisia Rating Scale (BARS) | Baseline, Day 35±7, Day 91±7, Day 175±7 | 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. |
| Abnormal Involuntary Movement Scale (AIMS) | Baseline, Day 35±7, Day 91±7, Day 175±7 | 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. |
| Extrapyramidal Symptom Rating Scale (SAS) | Baseline, Day 35±7, Day 91±7, Day 175±7 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| electrocardiogram (ECG) | Baseline, Day 35±7, Day 91±7, Day 175±7 | To analysis whether ECG QT Interval of participants show any significant trend with time changes. |
| Prolactin (PRL) | Baseline, Day 35±7, Day 91±7, Day 175±7 | To analysis whether PRL level of participants show any significant trend with time changes. |
| Alanine Aminotransferase (ALT) | Baseline, Day 35±7, Day 91±7, Day 175±7 | To analysis whether ALT level of participants show any significant trend with time changes. |
| Glucose (GLU) | Baseline, Day 35±7, Day 91±7, Day 175±7 | To analysis whether GLU level of participants show any significant trend with time changes. |
| Total Cholesterol (TC) | Baseline, Day 35±7, Day 91±7, Day 175±7 | To analysis whether TC level of participants show any significant trend with time changes. |
| High-Density Lipoprotein Cholesterol (HDL-C) | Baseline, Day 35±7, Day 91±7, Day 175±7 | To analysis whether HDL-C level of participants show any significant trend with time changes. |
| Low-Density Lipoprotein Cholesterol (LDL-C) | Baseline, Day 35±7, Day 91±7, Day 175±7 | To analysis whether LDL-C level of participants show any significant trend with time changes. |
| Triglycerides (TG) | Baseline, Day 35±7, Day 91±7, Day 175±7 | To analysis whether TG level of participants show any significant trend with time changes. |
Countries
China
Contacts
Primary ContactHao Tang, MD
Outcome results
None listed