SchizophreniaPhase 4NCT07075237
Efficacy and Functional Recovery After Switching From Paliperidone Palmitate Injection to Oral Antipsychotics in Schizophrenia
A Phase 4 study testing Paliperidone Palmitate Injection (PP1M) in people with Schizophrenia, run by Jiangsu Province Nanjing Brain Hospital at 1 site in China.
Trial summary
To evaluate the efficacy of Paliperidone Palmitate Injection in replacing oral antipsychotics for the treatment of schizophrenia and its impact on social function Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Paliperidone Palmitate Injection (PP1M)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Oct 2025to Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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. |
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Nanjing Brain Hospital
Nanjing, Jiangsu, 210024
Hao Tang, MD, +86 18913821399, tanghao997@163.com
About this study
Official title: A Study on the Efficacy and Functional Recovery of Switching From Oral Antipsychotics to Paliperidone Palmitate Injection in the Treatment of Schizophrenia
To evaluate the efficacy of Paliperidone Palmitate Injection in replacing oral antipsychotics for the treatment of schizophrenia and its impact on social function
Read the 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
- Being tested
- Paliperidone Palmitate Injection (PP1M)
- Keywords
- Schizophrenia, Paliperidone Palmitate, Oral antipsychotics, Social function|
- Medical subject headings
- Schizophrenia, Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Switching from Oral Antipsychotics to Paliperidone Palmitate Injection in the Treatment of Schizophrenia Patients Receives: Drug: Paliperidone Palmitate Injection (PP1M) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 175±7
Secondary outcomes (6)
Personal and Social Performance (PSP)
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.
Measured: Baseline, Day 35±7, Day 91±7, Day 175±7
EuroQol-5 Dimensions (EQ-5D)
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.
Measured: Baseline, Day 35±7, Day 91±7, Day 175±7
Clinical Global Impression-Severity (CGI-S)
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.
Measured: Baseline, Day 35±7, Day 91±7, Day 175±7
Extrapyramidal Symptom Rating Scale (SAS)
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.
Measured: Baseline, Day 35±7, Day 91±7, Day 175±7
Barnes Akathisia Rating Scale (BARS)
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.
Measured: Baseline, Day 35±7, Day 91±7, Day 175±7
Abnormal Involuntary Movement Scale (AIMS)
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.
Measured: Baseline, Day 35±7, Day 91±7, Day 175±7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study startOct 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Nanjing Brain Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075237
- Sponsor's protocol ID
- JiangsuPNBH
- Status last verified
- Sep 2025
- First submitted
- 11 Jul 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Efficacy and Functional Recovery of Switching From Oral Antipsychotics to Paliperidone Palmitate Injection in the Treatment of Schizophrenia
- ClinicalTrials.gov ID
- NCT07075237
- Acronym / sponsor ID
- JiangsuPNBH
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Paliperidone Palmitate, Oral antipsychotics, Social function|
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Jiangsu Province Nanjing Brain HospitalUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Paliperidone Palmitate Injection (PP1M)Switching from Oral Antipsychotics to Paliperidone Palmitate Injection in the Treatment of Schizophrenia Patients |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (8 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Treatment group |
Primary outcome
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paliperidone Palmitate Injection (PP1M) in people with Schizophrenia, run by Jiangsu Province Nanjing Brain Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hao Tang, MD (+86 18913821366, tanghao997@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Positive and Negative Syndrome Scale (PANSS) (time frame: Day 175±7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.