A Study of Transition to the Paliperidone Palmitate 3-Month Formulation In Participants With Schizophrenia Previously Stabilized on the Paliperidone Palmitate 1-Month Formulation
NCT ID: NCT02713282
Last Updated: 2025-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
306 participants
INTERVENTIONAL
2016-04-28
2018-03-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Patients With Schizophrenia
NCT01529515
Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Patients With Schizophrenia
NCT01515423
Paliperidone Palmitate Flexible Dosing in Schizophrenia
NCT01281527
A Study of Paliperidone Palmitate 6-Month Formulation
NCT04072575
A Study of Paliperidone Palmitate 6-Month Formulation
NCT03345342
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Janssen-Cilag Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Janssen-Cilag Limited Clinical Trial
Role: STUDY_DIRECTOR
Janssen-Cilag Limited
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rijeka, , Croatia
Zagreb, , Croatia
Esbjerg, , Denmark
Clermont-Ferrand, , France
Montpellier, , France
Paris, , France
Rennes, , France
Toulon, , France
Berlin, , Germany
Hamburg, , Germany
Oranienburg, , Germany
Stralsund, , Germany
Athens, , Greece
Heraklion, , Greece
Nea Kifissia, , Greece
Thessaloniki, , Greece
Beer Yaakov, , Israel
Ramat Gan, , Israel
Ipoh, , Malaysia
Johor Bahru, , Malaysia
Kuala Lumpur, , Malaysia
Assen, , Netherlands
Groningen, , Netherlands
Moscow, , Russia
Saint Petersburg, , Russia
Jeddah, , Saudi Arabia
Gwangju, , South Korea
Gyeonggi-do, , South Korea
Jeonju, , South Korea
Seoul, , South Korea
Bilbao, , Spain
Madrid, , Spain
Oviedo, , Spain
Sabadell, , Spain
Torrevieja, , Spain
Valencia, , Spain
New Taipei City, , Taiwan
Tainan City, , Taiwan
Taoyuan District, , Taiwan
Ankara, , Turkey (Türkiye)
Bursa, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Sakarya, , Turkey (Türkiye)
Derby, , United Kingdom
Edinburgh, , United Kingdom
Reading, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015-004835-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
R092670SCH3015
Identifier Type: OTHER
Identifier Source: secondary_id
CR108121
Identifier Type: -
Identifier Source: org_study_id
NCT02772393
Identifier Type: -
Identifier Source: nct_alias
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.