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

Jiangsu Province Nanjing Brain Hospital

Status and phase: Not yet enrolling; Phase 4

Conditions: Schizophrenia

Treatments: Drug: Paliperidone Palmitate Injection (PP1M)

Study type: Interventional

Funder types: Other

Identifiers

NCT07075237

JiangsuPNBH

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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. |

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Treatment group

Experimental group

Description:

Switching from Oral Antipsychotics to Paliperidone Palmitate Injection in the Treatment of Schizophrenia Patients

Treatment:

Drug: Paliperidone Palmitate Injection (PP1M)