A Study of Paliperidone Palmitate 6-Month Formulation

NCT ID: NCT04072575

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-19
• Study Completion Date: 2022-05-03

Brief Summary

The main purpose of this study is to assess the long-term safety and tolerability of paliperidone 6-month PP6M (Dose 1 or Dose 2 [milligram] mg eq.) and to provide access to PP6M in participants with schizophrenia completing the R092670PSY3015 study without relapse.

Conditions

Schizophrenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Paliperidone Palmitate 6 month(PP6M)

Participants who enter the this open-label extension study immediately after completing Double-blind Phase Study R092670PSY3015 (previous study) will receive Paliperidone Palmitate 6 month (PP6M) intramuscular (IM) injections, dose will be selected based on the unblinded dose level ("moderate" or "higher") that the participant received during previous study. Participants in the "moderate" dose level will receive PP6M Dose 1 and "higher" dose level will receive PP6M Dose 2 during the open-label extension. The PP6M dose level may be adjusted (to Dose 1 or Dose 2) for every 6 month at Visits 3, 5, and 7, based on clinical judgment. Participants who enter this open-label extension study later (up to 3 months after they complete previous study) and were on a moderate or higher dose of PP3M (350 or 525 mg eq.) or PP1M (100 or 150 mg eq.) will receive initial dose of PP6M IM injection (Dose 1 or Dose 2) for every 6 months.

Group Type: EXPERIMENTAL

PP6M injection Dose 1

Intervention Type: DRUG

Participants will receive Dose 1 PP6M intramuscular (IM) injection at Visit 1 (Day) then once every 6 month up to 24 months.

PP6M injection Dose 2

Intervention Type: DRUG

Participants will receive Dose 2 PP6M IM injection at Visit 1 (Day) then once every 6 month up to 24 months.

Interventions

PP6M injection Dose 1

Participants will receive Dose 1 PP6M intramuscular (IM) injection at Visit 1 (Day) then once every 6 month up to 24 months.

Intervention Type: DRUG

PP6M injection Dose 2

Participants will receive Dose 2 PP6M IM injection at Visit 1 (Day) then once every 6 month up to 24 months.

Intervention Type: DRUG

Other Intervention Names

R092670; R092670

Eligibility Criteria

Inclusion Criteria

• Completed the Double-blind Phase of Study R092670PSY3015 without relapse and continue to be willing to be treated with paliperidone palmitate 6 month injection (PP6M)
• Must, in the opinion of the investigator, be able to continue treatment at the same dose level (moderate or higher dose) as used during the Double-blind Phase of Study R092670PSY3015 at the time of screening for this study
• A woman of childbearing potential: a) Must have a negative pregnancy test on Day 1; b) Use contraception consistent with local regulations. A man must agree that during the study and for a minimum 12 months after receiving the last dose of the study intervention: a) His female partner(s) will use highly effective method pf contraception
• Sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study; and must be able to provide his or her own consent (that is, consent cannot be provided by a legal representative of the participant)
• In the opinion of the investigator, the patient would be able to participate for the duration of this study

Exclusion Criteria

• Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
• Completed R092670PSY3015 while presenting adverse events deemed clinically relevant by the investigator, and which may interfere with safety and well-being of the participant
• If a man, has plans to father a child while enrolled in this study or within 12 months after the last dose of study intervention. Must not, if a woman, have plans to become pregnant while enrolled in this study or within 12 months after the last dose of study intervention

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales

Buenos Aires, , Argentina

CEN Consultorios Especializados en Neurociencias

Córdoba, , Argentina

Sanatorio Prof. Leon S. Morra

Córdoba, , Argentina

INSA Instituto de Neurociencias San Agustín

La Plata, , Argentina

Clinica Privada de Salud Mental Santa Teresa de Ávila

La Plata, , Argentina

C I A P Centro de investigacion y Asistencia en Psiquiatria

Rosario, , Argentina

Queen Mary Hospital

Hong Kong, , Hong Kong

Dipartimento di Salute Mentale

Lecce, , Italy

Seconda Universita degli Studi di Napoli - Azienda Ospedaliera Universitaria

Napoli, , Italy

Universita degli Studi di Roma 'La Sapienza' - Azienda Ospedaliera Sant Andrea

Roma, , Italy

Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk

Bialystok, , Poland

Zespol Opieki Zdrowotnej w Chelmnie

Chełmno, , Poland

Centrum Badan Klinicznych PI House sp z o o

Gdansk, , Poland

Specjalistyczna Praktyka Lekarska Piotr Zalitacz

Gorlice, , Poland

Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS

Leszno, , Poland

Centrum Medyczne Luxmed Sp z o o

Lublin, , Poland

Poradnia Zdrowia Psychicznego 'Syntonia' w Pruszczu Gdanskim

Pruszcz Gdański, , Poland

Nizny Novgorod clinical psychiatric hospital 1

Nizny Novgorod, , Russia

SHI 'Saratov City Clinical Hospital 2 n.a V.I. Razumovsky

Saratov, , Russia

Saratov Regional Psychiatric hospital named after St. Sofia

Saratov, , Russia

Research Institute of Mental Health

Tomsk, , Russia

Sverdlovsk Regional Clinical Psychiatric Hospital

Yekaterinburg, , Russia

MNCE of Kyiv RC Regional Psychiatric and Narcological Medical Association

Hlevakha, , Ukraine

Mnpe of Kharkiv Regional Council 'Regional Clinical Psychiatric Hospital #3'

Kharkiv, , Ukraine

CNPE'Kherson Regional Institution of Mental Care'of Kherson Regional Council

Kherson, , Ukraine

Mnpe of Lviv Regional Council 'Lviv Regional Clinical Psycho-Neurological Dispensary'

Lviv, , Ukraine

CNCE of the Lviv Regional Council 'Lviv Regional Clinical Psychiatric Hospital'

Lviv, , Ukraine

CNCE Odesa regional psychiatric hospital #2 Odesa regional council

Oleksandrivka, , Ukraine

CNCE 'Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council'

Smila, , Ukraine

CNCE 'Vinnytsya RC Psychoneurological Hospital n.a. O.I. Yushchenko Vinnytsya RC'

Vinnytsia, , Ukraine

Countries

Argentina; Hong Kong; Italy; Poland; Russia; Ukraine

References

LaRoche JK, Lanier J, Alvarenga R, Collins M, Costelloe T, Chiau A, Whetherly H, De Soete W, Faludi J, Rens K. Climate footprint of industry-sponsored in-human clinical trials: life cycle assessments of clinical trials spanning multiple phases and disease areas. BMJ Open. 2025 Feb 19;15(2):e085364. doi: 10.1136/bmjopen-2024-085364.

Reference Type: DERIVED

PMID: 39971605 (View on PubMed)

Turkoz I, Daskiran M, Siddiqui U, Knight RK, Johnston KL, Correll CU. Relapse Rates With Paliperidone Palmitate in Adult Patients With Schizophrenia: Results for the 6-Month Formulation From an Open-label Extension Study Compared to Real-World Data for the 1-Month and 3-Month Formulations. Int J Neuropsychopharmacol. 2024 Feb 1;27(2):pyad067. doi: 10.1093/ijnp/pyad067.

Reference Type: DERIVED

PMID: 38300235 (View on PubMed)

Najarian D, Turkoz I, Knight RK, Galderisi S, Lamaison HF, Zalitacz P, Aravind S, Richarz U. Long-Term Efficacy and Safety of Paliperidone 6-Month Formulation: An Open-Label 2-Year Extension of a 1-Year Double-Blind Study in Adult Participants With Schizophrenia. Int J Neuropsychopharmacol. 2023 Aug 29;26(8):537-544. doi: 10.1093/ijnp/pyad028.

Reference Type: DERIVED

PMID: 37480362 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

R092670PSY3016

Identifier Type: OTHER

Identifier Source: secondary_id

2018-004532-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR108605

Identifier Type: -

Identifier Source: org_study_id