Efficacy and Functional Recovery After Switching From Paliperidone Palmitate Injection to Oral Antipsychotics in Schizophrenia

Официальное название

A Study on the Efficacy and Functional Recovery of Switching From Oral Antipsychotics to Paliperidone Palmitate Injection in the Treatment of Schizophrenia

Обзор

To evaluate the efficacy of Paliperidone Palmitate Injection in replacing oral antipsychotics for the treatment of schizophrenia and its impact on social function

Подробное описание

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.

Вмешательства

• Препарат Paliperidone Palmitate Injection (PP1M)
  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.

Первичные конечные точки

• The Positive and Negative Syndrome Scale (PANSS) [Срок оценки: Day 175±7]

Вторичные конечные точки (6)

• Personal and Social Performance (PSP) [Срок оценки: Baseline, Day 35±7, Day 91±7, Day 175±7]
• EuroQol-5 Dimensions (EQ-5D) [Срок оценки: Baseline, Day 35±7, Day 91±7, Day 175±7]
• Clinical Global Impression-Severity (CGI-S) [Срок оценки: Baseline, Day 35±7, Day 91±7, Day 175±7]
• Extrapyramidal Symptom Rating Scale (SAS) [Срок оценки: Baseline, Day 35±7, Day 91±7, Day 175±7]
• Barnes Akathisia Rating Scale (BARS) [Срок оценки: Baseline, Day 35±7, Day 91±7, Day 175±7]
• Abnormal Involuntary Movement Scale (AIMS) [Срок оценки: Baseline, Day 35±7, Day 91±7, Day 175±7]

Критерии участия

Критерии включения

• 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;

Критерии исключения

• 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;
• Current or history of tardive dyskinesia (TD), neuroleptic malignant syndrome (NMS), or severe extrapyramidal symptoms (EPS);
• Treatment-resistant schizophrenia (failure of ≥2 adequate antipsychotic regimens of different compounds);
• 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. \|

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Nanjing Brain Hospital — Нанкин

Идентификаторы

NCT: NCT07075237 · JiangsuPNBH

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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