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

Official title

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

Overview

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

• Drug 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.

Primary outcome measures

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

Secondary outcome measures (6)

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

Eligibility criteria

Inclusion criteria

• 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;

Exclusion criteria

• 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. \|

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Nanjing Brain Hospital — Nanjing

Identifiers

NCT: NCT07075237 · JiangsuPNBH

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗