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

NCT07075237 | Not Yet Recruiting Phase 4

• 1 other identifier: JiangsuPNBH
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Schizophrenia

Keywords

Schizophrenia; Paliperidone Palmitate; Oral antipsychotics; Social function|

Outcome Measures

Primary Outcomes (1)

• The Positive and Negative Syndrome Scale (PANSS)

  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.

  Day 175±7

Secondary Outcomes (6)

• Personal and Social Performance (PSP)

  Baseline, Day 35±7, Day 91±7, Day 175±7

• EuroQol-5 Dimensions (EQ-5D)

  Baseline, Day 35±7, Day 91±7, Day 175±7

• Clinical Global Impression-Severity (CGI-S)

  Baseline, Day 35±7, Day 91±7, Day 175±7

• Extrapyramidal Symptom Rating Scale (SAS)

  Baseline, Day 35±7, Day 91±7, Day 175±7

• Barnes Akathisia Rating Scale (BARS)

  Baseline, Day 35±7, Day 91±7, Day 175±7

Other Outcomes (8)

• electrocardiogram (ECG)

  Baseline, Day 35±7, Day 91±7, Day 175±7

• Alanine Aminotransferase (ALT)

  Baseline, Day 35±7, Day 91±7, Day 175±7

• Glucose (GLU)

  Baseline, Day 35±7, Day 91±7, Day 175±7

Study Arms (1)

Treatment group

EXPERIMENTAL

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

Drug: Paliperidone Palmitate Injection (PP1M)

Interventions

Paliperidone Palmitate Injection (PP1M) 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.

Treatment group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;
• \. Other conditions deemed unsuitable by the investigator. \|

Sponsors & Collaborators

• Jiangsu Province Nanjing Brain Hospital: lead

Study Sites (1)

Nanjing Brain Hospital

Nanjing, Jiangsu, 210024, China

Location

MeSH Terms

Conditions

Schizophrenia; Social Adjustment

Interventions

Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Central Study Contacts

Hao Tang, MD

CONTACT

+86 18913821366; tanghao997@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 20, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

CN (1)