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

NCT ID: NCT07075237

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2027-03-31

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

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

Group Type: EXPERIMENTAL

Paliperidone Palmitate Injection (PP1M)

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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. |

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Province Nanjing Brain Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nanjing Brain Hospital

Nanjing, Jiangsu, China

Countries

China

Central Contacts

Hao Tang, MD

Role: CONTACT

tanghao997@163.com

+86 18913821366

Facility Contacts

Hao Tang, MD

Role: primary

tanghao997@163.com

+86 18913821399

Other Identifiers

JiangsuPNBH

Identifier Type: -

Identifier Source: org_study_id