A Phase 3 interventional study of Paliperidone palmitate 3 month formulation (PP3M) in Schizophrenia, sponsored by Janssen-Cilag Ltd.. Completed at 46 sites in 15 countries. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-04-27.
Sponsored by Janssen-Cilag Ltd. · Phase 3, Interventional, and Treatment
The purpose of this study is to estimate the proportion of participants fulfilling criteria for symptomatic remission following a transition to 12 months treatment with flexible-dose paliperidone palmitate 3 month formulation (PP3M) in participants with schizophrenia previously adequately treated with paliperidone palmitate 1 month formulation (PP1M) for at least 4 months.
This is an international, multicenter (study conducted at multiple sites) study designed to estimate remission rates and assess treatment response, tolerability, and patterns of use of Paliperidone Palmitate 3-Month Formulation (PP3M) in a diverse population of participants with schizophrenia. The study will consist of a screening phase (Day -7 to Day 1), a 52-week, open-label, flexible-dose PP3M treatment phase and a follow up safety assessment 3 months ( +/-14 days ) after the month 12 visit or early discontinuation. Participants' Safety will be monitored throughout the study.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 306 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
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Exclusion Criteria:
Participants will receive intramuscular injection of Paliperidone Palmitate 3-Month Formulation (PP3M) on Day 1 at a starting dose of 175 milligram equivalent (mg eq.) up to 525 mg eq. based on last Paliperidone Palmitate 1-Month Formulation (PP1M) dose (at a dose of 3.5-fold multiple of the participant's last PP1M dose). Subsequent PP3M injections will be given at Month 3, Month 6, and Month 9 and dose can be adjusted flexibly in increments within the range of 175 to 525 mg eq.
Drug: Paliperidone palmitate 3 month formulation (PP3M)
Participants will receive intramuscular injection of Paliperidone Palmitate 3-Month Formulation (PP3M) on Day 1 at a starting dose of 175 milligram equivalent (mg eq) up to 525 mg eq based on last Paliperidone Palmitate 1-Month Formulation (PP1M) dose (at a dose of 3.5-fold multiple of the participant's last PP1M dose). Subsequent PP3M injections will be given at Month 3, Month 6, and Month 9 and dose can be adjusted flexibly in increments within the range of 175 to 525 mg eq.
Percentage of Participants Achieving Symptomatic Remission Based on Positive and Negative Syndrome Scale (PANSS)
The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent), 2 (minimal), 3 (mild), 4 (moderate), 5 (moderately severe), 6 (severe) and 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity. Symptomatic remission is defined as achieving intensity level of mild or moderate on PANSS scale by all 8 items as the determinants for symptomatic remission: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, lack of spontaneity.
Time frame: Month 12
Percentage of Participants Achieving Symptomatic Remission Based on Positive and Negative Syndrome Scale (PANSS) at Month 6, 9 and 12
PANSS is a 30-item scale to assess neuropsychiatric symptoms of schizophrenia. PANSS provides a total score and scores for 3 subscales, positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items), each item scored on a scale of 1 (absent), 2 (minimal), 3 (mild), 4 (moderate), 5 (moderately severe), 6 (severe) and 7 (extreme). Total score ranges from 30 to 210 and higher score indicates greater severity. Symptomatic remission is defined as achieving intensity level of mild or moderate on PANSS scale by all 8 items as the determinants for symptomatic remission: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, lack of spontaneity with the achieved intensity level maintained for at least 6 months.
Time frame: Month 6, Month 9 , and Month 12
Time to Symptomatic Remission
Time to Symptomatic Remission will be reported. Symptomatic remission is defined as achieving intensity level of mild or moderate on PANSS scale by all 8 items as the determinants for symptomatic remission: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, lack of spontaneity with the achieved intensity level maintained for at least 6 months.
Time frame: Up to Month 12
Percentage of Participants who Meet the Remission Severity Criteria
Remission severity criteria that is, a score of mild or less \[less than or equal to 3\] on all selected PANSS items \[P1, P2, P3, N1, N4, N6, G5, and G9\]) at each time point.
Time frame: Up to Month 12
Non-Inferiority of Change in PANSS Total Score From Baseline to Month 12 last-observation-carried-forward (LOCF)
Maintained efficacy will be investigated using the Schuirmann's test to test the change at last-observation-carried-forward (LOCF) endpoint in total PANSS score at endpoint versus baseline with a non-inferiority margin of 5 points on the PANSS scale.
Time frame: Up to Month 12
The proportion of subjects with PANSS response
The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent), 2 (minimal), 3 (mild), 4 (moderate), 5 (moderately severe), 6 (severe) and 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity.
Time frame: Up to Month 12
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