A Study of Transition to the Paliperidone Palmitate 3-Month Formulation In Participants With Schizophrenia Previously Stabilized on the Paliperidone Palmitate 1-Month Formulation
A 52-Week, Open-Label, Prospective, Multicenter, International Study of a Transition to the Paliperidone Palmitate 3-Month Formulation In Patients With Schizophrenia Previously Stabilized on the Paliperidone Palmitate 1-Month Formulation
3 other identifiers
interventional
306
15 countries
46
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 schizophrenia
Started Apr 2016
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2016
CompletedFirst Posted
Study publicly available on registry
March 18, 2016
CompletedStudy Start
First participant enrolled
April 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 26, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 26, 2018
CompletedApril 27, 2025
April 1, 2025
1.9 years
March 15, 2016
April 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Month 12
Secondary Outcomes (5)
Percentage of Participants Achieving Symptomatic Remission Based on Positive and Negative Syndrome Scale (PANSS) at Month 6, 9 and 12
Month 6, Month 9 , and Month 12
Time to Symptomatic Remission
Up to Month 12
Percentage of Participants who Meet the Remission Severity Criteria
Up to Month 12
Non-Inferiority of Change in PANSS Total Score From Baseline to Month 12 last-observation-carried-forward (LOCF)
Up to Month 12
The proportion of subjects with PANSS response
Up to Month 12
Study Arms (1)
Paliperidone palmitate 3 month formulation (PP3M)
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Meets Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) criteria for a diagnosis of schizophrenia
- Able to read, understand, and sign the informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study
- Willing and able to fill out self-administered questionnaires
- Willing and able to adhere to the prohibitions and restrictions specified in the protocol
- A woman of childbearing potential must have a negative urine pregnancy test at Screening and baseline
- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 6 months after receiving the last dose of study drug
You may not qualify if:
- His/her psychiatric diagnosis is due to direct pharmacological effects of a substance (example, a drug of abuse or medication) or a general medical condition (example, clinically notable hypothyroidism, organic brain disorder)
- Experienced intolerable side effects during treatment with paliperidone palmitate 1-month formulation (PP1M)
- Has a known hypersensitivity to paliperidone or risperidone
- Has received any other long-acting injectable antipsychotic medication other than PP1M within the last 4 months before the first injection of the study drug paliperidone palmitate 3-month formulation (PP3M)
- Has received clozapine during the last 3 months before the Screening visit
- Is considered to be at imminent risk of suicide, even after clinical intervention
- Has a serious unstable medical condition, including recent and present clinically relevant laboratory abnormalities
- Has a history or current symptoms of tardive dyskinesia or neuroleptic malignant syndrome
- Is a woman who is pregnant or breast-feeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of PP3M
- Has participated in an investigational drug trial in the 30 days prior to the Screening visit or is currently enrolled in an investigational study
- Has a current DSM-5 diagnosis of dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, autistic disorder, or intellectual disabilities and/or meets the DSM-5 definition of severe substance use disorder (except for nicotine and caffeine) within 6 months prior to screening; however, participants with mild or moderate substance use disorder, with the exception of intravenous drug use, will be eligible for enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (46)
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Rijeka, Croatia
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Zagreb, Croatia
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Esbjerg, Denmark
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Clermont-Ferrand, France
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Montpellier, France
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Paris, France
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Rennes, France
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Toulon, France
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Berlin, Germany
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Hamburg, Germany
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Oranienburg, Germany
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Stralsund, Germany
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Athens, Greece
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Heraklion, Greece
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Nea Kifissia, Greece
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Thessaloniki, Greece
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Beer Yaakov, Israel
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Ramat Gan, Israel
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Ipoh, Malaysia
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Johor Bahru, Malaysia
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Kuala Lumpur, Malaysia
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Assen, Netherlands
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Groningen, Netherlands
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Moscow, Russia
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Saint Petersburg, Russia
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Jeddah, Saudi Arabia
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Gwangju, South Korea
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Gyeonggi-do, South Korea
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Jeonju, South Korea
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Seoul, South Korea
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Bilbao, Spain
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Madrid, Spain
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Oviedo, Spain
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Sabadell, Spain
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Torrevieja, Spain
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Valencia, Spain
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New Taipei City, Taiwan
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Tainan, Taiwan
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Taoyuan District, Taiwan
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Ankara, Turkey (Türkiye)
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Bursa, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Sakarya, Turkey (Türkiye)
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Derby, United Kingdom
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Edinburgh, United Kingdom
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Reading, United Kingdom
Related Publications (1)
Pungor K, Bozikas VP, Emsley R, Llorca PM, Gopal S, Mathews M, Wooller A, Bergmans P. Stable patients with schizophrenia switched to paliperidone palmitate 3-monthly formulation in a naturalistic setting: impact of patient age and disease duration on outcomes. Ther Adv Psychopharmacol. 2020 Dec 23;10:2045125320981500. doi: 10.1177/2045125320981500. eCollection 2020.
PMID: 35186258DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen-Cilag Limited Clinical Trial
Janssen-Cilag Limited
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2016
First Posted
March 18, 2016
Study Start
April 28, 2016
Primary Completion
March 26, 2018
Study Completion
March 26, 2018
Last Updated
April 27, 2025
Record last verified: 2025-04