A Study of Paliperidone Palmitate 6-Month Formulation

NCT04072575 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: CR108605R092670PSY30162018-004532-30
• Study Type: interventional
• Target: 178
• Locations: 6 countries
• Sites: 30

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

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Relapse

  Number of participants with relapse were reported. Relapse is defined as one or more of the following: a) Psychiatric hospitalization for schizophrenia (involuntary or voluntary admission to a psychiatric hospital for decompensation of the participant's schizophrenic symptoms); b) Emergency Department/Room/Ward visit due to a worsening of the participant's symptoms of schizophrenia, but a psychiatric hospitalization does not occur; c) The participant inflicts deliberate self-injury or exhibits violent behaviour resulting in suicide, clinically significant injury to him/herself or another person, or significant property damage; d) The participant has suicidal or homicidal ideation and aggressive behaviour that is clinically significant (in frequency and severity) in the investigator's judgment.

  Up to Day 730

• Number of Participants With Treatment-emergent Adverse Events (TEAEs)

  An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. TEAEs are those events if they started after administration of the first dose and until 183 days after the last dose of study medication.

  Up to Day 730

Secondary Outcomes (3)

• Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score

  Baseline up to Day 730

• Change From Baseline in Personal and Social Performance (PSP) Scale Score

  Baseline up to Day 730

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score

  Baseline up to Day 730

Study Arms (1)

Paliperidone Palmitate 6 month(PP6M)

EXPERIMENTAL

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.

Drug: PP6M injection Dose 1; Drug: PP6M injection Dose 2

Interventions

PP6M injection Dose 1 DRUG

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

Also known as: R092670

Paliperidone Palmitate 6 month(PP6M)

PP6M injection Dose 2 DRUG

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

Also known as: R092670

Paliperidone Palmitate 6 month(PP6M)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (30)

Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales

Buenos Aires, C1133AAH, Argentina

Location

CEN Consultorios Especializados en Neurociencias

Córdoba, X5004FJF, Argentina

Location

Sanatorio Prof. Leon S. Morra

Córdoba, X5009BIN, Argentina

Location

INSA Instituto de Neurociencias San Agustín

La Plata, 1900, Argentina

Location

Clinica Privada de Salud Mental Santa Teresa de Ávila

La Plata, B1904ADM, Argentina

Location

C I A P Centro de investigacion y Asistencia en Psiquiatria

Rosario, 2000, Argentina

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Dipartimento di Salute Mentale

Lecce, 73100, Italy

Location

Seconda Universita degli Studi di Napoli - Azienda Ospedaliera Universitaria

Napoli, 80138, Italy

Location

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

Roma, 00189, Italy

Location

Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk

Bialystok, 15-404, Poland

Location

Zespol Opieki Zdrowotnej w Chelmnie

Chełmno, 86-200, Poland

Location

Centrum Badan Klinicznych PI House sp z o o

Gdansk, 80 546, Poland

Location

Specjalistyczna Praktyka Lekarska Piotr Zalitacz

Gorlice, 38-300, Poland

Location

Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS

Leszno, 64-100, Poland

Location

Centrum Medyczne Luxmed Sp z o o

Lublin, 20 109, Poland

Location

Poradnia Zdrowia Psychicznego 'Syntonia' w Pruszczu Gdanskim

Pruszcz Gdański, 83-000, Poland

Location

Nizny Novgorod clinical psychiatric hospital 1

Nizny Novgorod, 603155, Russia

Location

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

Saratov, 410028, Russia

Location

Saratov Regional Psychiatric hospital named after St. Sofia

Saratov, 410060, Russia

Location

Research Institute of Mental Health

Tomsk, 634014, Russia

Location

Sverdlovsk Regional Clinical Psychiatric Hospital

Yekaterinburg, Russia

Location

MNCE of Kyiv RC Regional Psychiatric and Narcological Medical Association

Hlevakha, 8630, Ukraine

Location

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

Kharkiv, 61068, Ukraine

Location

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

Kherson, 73488, Ukraine

Location

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

Lviv, 79000, Ukraine

Location

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

Lviv, 79021, Ukraine

Location

CNCE Odesa regional psychiatric hospital #2 Odesa regional council

Oleksandrivka, 67513, Ukraine

Location

CNCE 'Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council'

Smila, 20708, Ukraine

Location

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

Vinnytsia, 21005, Ukraine

Location

Related Publications (3)

• 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.

  PMID: 39971605 DERIVED

• 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.

  PMID: 38300235 DERIVED

• 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.

  PMID: 37480362 DERIVED

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Limitations and Caveats

The sponsor identified that the study did not include a control arm reference group. The coronavirus disease-2019 (COVID-19) pandemic placed some restrictions on study face-to-face visits.

Results Point of Contact

• Title: Director Clinical Leader
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: August 16, 2019
• First Posted: August 28, 2019
• Study Start: September 19, 2019
• Primary Completion: May 3, 2022
• Study Completion: May 3, 2022
• Last Updated: April 29, 2025
• Results First Posted: May 31, 2023

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

IT (3); PL (7); AR (6); HK (1); RU (5); UA (8)