A Study of Paliperidone Palmitate 6-Month Formulation

Single-arm, Open-label Extension to a Double-blind, Randomized, Active-controlled, Parallel-group Study of Paliperidone Palmitate 6-Month Formulation

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: PP6M injection Dose 1; Drug: PP6M injection Dose 2

• Study Type: Interventional
• Enrollment (Actual): 178
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autónoma De Buenos Aires, Argentina, C1133AAH
    • Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales
  • Cordoba, Argentina, X5009BIN
    • Sanatorio Prof. Leon S. Morra
  • Cordoba, Argentina, X5004FJF
    • CEN-Consultorios Especializados en Neurociencias
  • La Plata, Argentina, 1900
    • INSA Instituto de Neurociencias San Agustín
  • La Plata, Argentina, B1904ADM
    • Clinica Privada de Salud Mental Santa Teresa de Avila
  • Rosario, Argentina, 2000
    • C.I.A.P. (Centro de investigación y Asistencia en Psiquiatría)
• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital
• Italy
  • Lecce, Italy, 73100
    • Dipartimento di Salute Mentale
  • Napoli, Italy, 80138
    • Seconda Universita degli Studi di Napoli - Azienda Ospedaliera Universitaria
  • Roma, Italy, 00189
    • Universita degli Studi di Roma 'La Sapienza' - Azienda Ospedaliera Sant Andrea
• Poland
  • Bialystok, Poland, 15-404
    • Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk
  • Chelmno, Poland, 86-200
    • Zespol Opieki Zdrowotnej w Chelmnie
  • Gdansk, Poland, 80-546
    • Centrum Badan Klinicznych PI-House sp. z o.o.
  • Gorlice, Poland, 38-300
    • Specjalistyczna Praktyka Lekarska Piotr Zalitacz
  • Leszno, Poland, 64-100
    • Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
  • Lublin, Poland, 20-109
    • Centrum Medyczne Luxmed Sp z o o
  • Pruszcz Gdanski, Poland, 83-000
    • Poradnia Zdrowia Psychicznego 'Syntonia' w Pruszczu Gdanskim
• Russian Federation
  • Ekaterinburg, Russian Federation
    • Sverdlovsk Regional Clinical Psychiatric Hospital
  • Nizny Novgorod, Russian Federation, 603155
    • Nizny Novgorod clinical psychiatric hospital 1
  • Saratov, Russian Federation, 410028
    • SHI 'Saratov City Clinical Hospital 2 n.a V.I. Razumovsky
  • Saratov, Russian Federation, 410060
    • Saratov Regional Psychiatric hospital named after St. Sofia
  • Tomsk, Russian Federation, 634014
    • Research Institute of Mental Health
• Ukraine
  • Glevakha, Ukraine, 8630
    • MNCE of Kyiv RC Regional Psychiatric and Narcological Medical Association
  • Kharkiv, Ukraine, 61068
    • Mnpe of Kharkiv Regional Council 'Regional Clinical Psychiatric Hospital #3'
  • Kherson, Ukraine, 73488
    • CNPE'Kherson Regional Institution of Mental Care'of Kherson Regional Council
  • Lviv, Ukraine, 79021
    • CNCE of the Lviv Regional Council 'Lviv Regional Clinical Psychiatric Hospital'
  • Lviv, Ukraine, 79000
    • Mnpe of Lviv Regional Council 'Lviv Regional Clinical Psycho-Neurological Dispensary'
  • Oleksandrivka, Ukraine, 67513
    • CNCE Odesa regional psychiatric hospital #2 Odesa regional council
  • Smila, Ukraine, 20708
    • CNCE 'Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council'
  • Vinnytsia, Ukraine, 21005
    • CNCE 'Vinnytsya RC Psychoneurological Hospital n.a. O.I. Yushchenko Vinnytsya RC'

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Drug: 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.; Other Names: R092670; 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.; Other Names: R092670

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score	Change from baseline in CGI-S scale score was reported. CGI-S is defined as clinician-rated scale that assesses the severity of mental illness on a scale of 0 to 7. Considering total clinical experience, a participant was assessed on severity of mental illness at the time of rating according to:1: normal, not at all ill; 2: borderline mentally ill; 3: mildly ill; 4: moderately ill; 5: markedly ill; 6: severely ill; 7: among the most extremely ill participants. A higher score implies a more severe condition.	Baseline up to Day 730
Change From Baseline in Personal and Social Performance (PSP) Scale Score	Change from baseline in PSP scale score was reported. The PSP scale assesses degree of a participant's dysfunction within 4 domains of behavior: 1) socially useful activities, 2) personal and social relationships, 3) self-care, and 4) disturbing and aggressive behavior. Each domain was assessed on a 6-point scale, from 1 (absent) to 6 (very severe) (1 = absent, 2 = mild, 3 = manifest, 4 = marked, 5 = severe, and 6 = very severe). PSP total score was calculated as sum of all the domain scores and ranges from 1 to 100. Participants with score of 71 to 100 had mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision. Higher score indicates better performance.	Baseline up to Day 730
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score	Change from baseline in PANSS total score were reported. The neuropsychiatric symptoms of schizophrenia were assessed using the 30-item PANSS scale, which provides a total score (sum of the scores for all 30 items) and scores for 3 subscales: the 7-item positive-symptom (P) subscale, the 7-item negative-symptom (N) subscale, and the 16-item general-psychopathology symptom (G) subscale. Each item is rated on a scale of 1 (absent) to 7 (extreme). The PANSS total score ranges from 30 (absent disease)-210 (more severe neuropsychiatric symptoms of schizophrenia).	Baseline up to Day 730

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2019
• Primary Completion (Actual): May 3, 2022
• Study Completion (Actual): May 3, 2022

Study Registration Dates

• First Submitted: August 16, 2019
• First Submitted That Met QC Criteria: August 27, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 3, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: CR108605; R092670PSY3016 (Other Identifier: Janssen Research & Development, LLC); 2018-004532-30 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes