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NCT Number: NCT07075237

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

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

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • Other conditions deemed unsuitable by the investigator. |

Treatment and study plan

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.

Primary outcomes

  1. The Positive and Negative Syndrome Scale (PANSS)

    Time frame: Day 175±7

    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.

Secondary outcomes

  1. Personal and Social Performance (PSP)

    Time frame: Baseline, Day 35±7, Day 91±7, Day 175±7

    The Personal and Social Performance (PSP) scale is a clinician-rated assessment tool designed to measure an individual's social and personal functioning across four key domains: socially useful activities (e.g., work/studies), personal/social relationships, self-care, and disruptive/aggressive behaviors. Scores range from 0 to 100, with higher values indicating better functional capacity. Widely used in mental health research and clinical practice, it provides a standardized way to evaluate functional impairment and recovery progress in conditions like schizophrenia.

  2. EuroQol-5 Dimensions (EQ-5D)

    Time frame: Baseline, Day 35±7, Day 91±7, Day 175±7

    The EQ-5D (EuroQol-5 Dimensions) is a standardized, self-reported questionnaire used to assess health-related quality of life. It evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated across three or five severity levels (depending on the version: EQ-5D-3L or EQ-5D-5L). Widely applied in health economics and clinical research, it aids in cost-effectiveness analyses and treatment outcome comparisons.

  3. Clinical Global Impression-Severity (CGI-S)

    Time frame: Baseline, Day 35±7, Day 91±7, Day 175±7

    A single-item, 7-point clinician rating (1=normal to 7=extremely severe) evaluating global psychiatric illness severity. Not diagnosis-specific, it provides rapid assessment of symptom intensity across mental disorders.

  4. Extrapyramidal Symptom Rating Scale (SAS)

    Time frame: Baseline, Day 35±7, Day 91±7, Day 175±7

    A clinician-administered tool assessing drug-induced movement disorders, including parkinsonism, dystonia, and akathisia. Rates 10 items (e.g., rigidity, tremor) on a 0-4 severity scale (total range 0-40). Widely used to monitor antipsychotic side effects.

  5. Barnes Akathisia Rating Scale (BARS)

    Time frame: Baseline, Day 35±7, Day 91±7, Day 175±7

    A structured scale measuring antipsychotic-induced akathisia (motor restlessness). Combines:

    Subjective distress (0-5) Objective movements (0-5) Global severity (0-5) Critical for differentiating akathisia from anxiety/agitation.

  6. Abnormal Involuntary Movement Scale (AIMS)

    Time frame: Baseline, Day 35±7, Day 91±7, Day 175±7

    A 12-item observational tool screening tardive dyskinesia severity. Focuses on facial/oral, extremity, and truncal involuntary movements (rated 0-4 per item). Requires baseline/follow-up assessments for longitudinal monitoring.

Other outcomes

  1. electrocardiogram (ECG)

    Time frame: Baseline, Day 35±7, Day 91±7, Day 175±7

    To analysis whether ECG QT Interval of participants show any significant trend with time changes.

  2. Alanine Aminotransferase (ALT)

    Time frame: Baseline, Day 35±7, Day 91±7, Day 175±7

    To analysis whether ALT level of participants show any significant trend with time changes.

  3. Glucose (GLU)

    Time frame: Baseline, Day 35±7, Day 91±7, Day 175±7

    To analysis whether GLU level of participants show any significant trend with time changes.

  4. Total Cholesterol (TC)

    Time frame: Baseline, Day 35±7, Day 91±7, Day 175±7

    To analysis whether TC level of participants show any significant trend with time changes.

  5. High-Density Lipoprotein Cholesterol (HDL-C)

    Time frame: Baseline, Day 35±7, Day 91±7, Day 175±7

    To analysis whether HDL-C level of participants show any significant trend with time changes.

  6. Low-Density Lipoprotein Cholesterol (LDL-C)

    Time frame: Baseline, Day 35±7, Day 91±7, Day 175±7

    To analysis whether LDL-C level of participants show any significant trend with time changes.

  7. Triglycerides (TG)

    Time frame: Baseline, Day 35±7, Day 91±7, Day 175±7

    To analysis whether TG level of participants show any significant trend with time changes.

  8. Prolactin (PRL)

    Time frame: Baseline, Day 35±7, Day 91±7, Day 175±7

    To analysis whether PRL level of participants show any significant trend with time changes.

Study contacts

Contact information is provided by the study sponsor or research team.

Hao Tang, MD

CONTACT

[email protected]

+86 18913821366

Sponsors and collaborators

Lead sponsor

Jiangsu Province Nanjing Brain Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jul 20, 2025
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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