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A Study of Paliperidone Palmitate 6-Month Formulation

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
PP6M injection Dose 1
PP6M injection Dose 2
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fundación para el Estudio y Tratamiento de las Enfermedades Mentales
  • CEN-Consultorios Especializados en Neurociencias
  • Sanatorio Prof. Leon S. Morra
  • INSA Instituto de Neurociencias San Agustín
  • Clinica Privada de Salud Mental Santa Teresa de Ávila
  • C.I.A.P. (Centro de investigación y Asistencia en Psiquiatría)
  • Queen Mary Hospital
  • Dipartimento di Salute Mentale
  • Seconda Universita degli Studi di Napoli - Azienda Ospedaliera Universitaria
  • Universita degli Studi di Roma 'La Sapienza' - Azienda Ospedaliera Sant Andrea
  • Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk
  • Zespol Opieki Zdrowotnej w Chelmnie
  • Centrum Badań Klinicznych PI-House sp. z o.o.
  • Specjalistyczna Praktyka Lekarska Piotr Zalitacz
  • Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
  • Centrum Medyczne Luxmed Sp z o o
  • Poradnia Zdrowia Psychicznego 'Syntonia' w Pruszczu Gdanskim
  • Sverdlovsk Regional Clinical Psychiatric Hospital
  • Nizny Novgorod clinical psychiatric hospital 1
  • SHI 'Saratov City Clinical Hospital 2 n.a V.I. Razumovsky
  • Saratov Regional Psychiatric hospital named after St. Sofia
  • Research Institute of Mental Health
  • MNCE of Kyiv RC Regional Psychiatric and Narcological Medical Association
  • Mnpe of Kharkiv Regional Council 'Regional Clinical Psychiatric Hospital #3'
  • CNPE'Kherson Regional Institution of Mental Care'of Kherson Regional Council
  • Mnpe of Lviv Regional Council 'Lviv Regional Clinical Psycho-Neurological Dispensary'
  • CNCE of the Lviv Regional Council 'Lviv Regional Clinical Psychiatric Hospital'
  • CNCE Odesa regional psychiatric hospital #2 Odesa regional council
  • CNCE 'Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council'
  • CNCE 'Vinnytsya RC Psychoneurological Hospital n.a. O.I. Yushchenko Vinnytsya RC'

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paliperidone Palmitate 6 month(PP6M)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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).

Full Information

First Posted
August 16, 2019
Last Updated
May 3, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04072575
Brief Title
A Study of Paliperidone Palmitate 6-Month Formulation
Official Title
Single-arm, Open-label Extension to a Double-blind, Randomized, Active-controlled, Parallel-group Study of Paliperidone Palmitate 6-Month Formulation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 19, 2019 (Actual)
Primary Completion Date
May 3, 2022 (Actual)
Study Completion Date
May 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
178 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paliperidone Palmitate 6 month(PP6M)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
PP6M injection Dose 1
Other Intervention Name(s)
R092670
Intervention Description
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
Intervention Name(s)
PP6M injection Dose 2
Other Intervention Name(s)
R092670
Intervention Description
Participants will receive Dose 2 PP6M IM injection at Visit 1 (Day) then once every 6 month up to 24 months.
Primary Outcome Measure Information:
Title
Number of Participants With Relapse
Description
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.
Time Frame
Up to Day 730
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Description
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.
Time Frame
Up to Day 730
Secondary Outcome Measure Information:
Title
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score
Description
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.
Time Frame
Baseline up to Day 730
Title
Change From Baseline in Personal and Social Performance (PSP) Scale Score
Description
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.
Time Frame
Baseline up to Day 730
Title
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
Description
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).
Time Frame
Baseline up to Day 730

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Fundación para el Estudio y Tratamiento de las Enfermedades Mentales
City
Ciudad Autónoma De Buenos Aires
ZIP/Postal Code
C1133AAH
Country
Argentina
Facility Name
CEN-Consultorios Especializados en Neurociencias
City
Cordoba
ZIP/Postal Code
X5004FJF
Country
Argentina
Facility Name
Sanatorio Prof. Leon S. Morra
City
Cordoba
ZIP/Postal Code
X5009BIN
Country
Argentina
Facility Name
INSA Instituto de Neurociencias San Agustín
City
La Plata
ZIP/Postal Code
1900
Country
Argentina
Facility Name
Clinica Privada de Salud Mental Santa Teresa de Ávila
City
La Plata
ZIP/Postal Code
B1904ADM
Country
Argentina
Facility Name
C.I.A.P. (Centro de investigación y Asistencia en Psiquiatría)
City
Rosario
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Dipartimento di Salute Mentale
City
Lecce
ZIP/Postal Code
73100
Country
Italy
Facility Name
Seconda Universita degli Studi di Napoli - Azienda Ospedaliera Universitaria
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Facility Name
Universita degli Studi di Roma 'La Sapienza' - Azienda Ospedaliera Sant Andrea
City
Roma
ZIP/Postal Code
00189
Country
Italy
Facility Name
Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk
City
Bialystok
ZIP/Postal Code
15-404
Country
Poland
Facility Name
Zespol Opieki Zdrowotnej w Chelmnie
City
Chelmno
ZIP/Postal Code
86-200
Country
Poland
Facility Name
Centrum Badań Klinicznych PI-House sp. z o.o.
City
Gdansk
ZIP/Postal Code
80-546
Country
Poland
Facility Name
Specjalistyczna Praktyka Lekarska Piotr Zalitacz
City
Gorlice
ZIP/Postal Code
38-300
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
City
Leszno
ZIP/Postal Code
64-100
Country
Poland
Facility Name
Centrum Medyczne Luxmed Sp z o o
City
Lublin
ZIP/Postal Code
20-109
Country
Poland
Facility Name
Poradnia Zdrowia Psychicznego 'Syntonia' w Pruszczu Gdanskim
City
Pruszcz Gdanski
ZIP/Postal Code
83-000
Country
Poland
Facility Name
Sverdlovsk Regional Clinical Psychiatric Hospital
City
Ekaterinburg
Country
Russian Federation
Facility Name
Nizny Novgorod clinical psychiatric hospital 1
City
Nizny Novgorod
ZIP/Postal Code
603155
Country
Russian Federation
Facility Name
SHI 'Saratov City Clinical Hospital 2 n.a V.I. Razumovsky
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Facility Name
Saratov Regional Psychiatric hospital named after St. Sofia
City
Saratov
ZIP/Postal Code
410060
Country
Russian Federation
Facility Name
Research Institute of Mental Health
City
Tomsk
ZIP/Postal Code
634014
Country
Russian Federation
Facility Name
MNCE of Kyiv RC Regional Psychiatric and Narcological Medical Association
City
Glevakha
ZIP/Postal Code
8630
Country
Ukraine
Facility Name
Mnpe of Kharkiv Regional Council 'Regional Clinical Psychiatric Hospital #3'
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
CNPE'Kherson Regional Institution of Mental Care'of Kherson Regional Council
City
Kherson
ZIP/Postal Code
73488
Country
Ukraine
Facility Name
Mnpe of Lviv Regional Council 'Lviv Regional Clinical Psycho-Neurological Dispensary'
City
Lviv
ZIP/Postal Code
79000
Country
Ukraine
Facility Name
CNCE of the Lviv Regional Council 'Lviv Regional Clinical Psychiatric Hospital'
City
Lviv
ZIP/Postal Code
79021
Country
Ukraine
Facility Name
CNCE Odesa regional psychiatric hospital #2 Odesa regional council
City
Oleksandrivka
ZIP/Postal Code
67513
Country
Ukraine
Facility Name
CNCE 'Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council'
City
Smila
ZIP/Postal Code
20708
Country
Ukraine
Facility Name
CNCE 'Vinnytsya RC Psychoneurological Hospital n.a. O.I. Yushchenko Vinnytsya RC'
City
Vinnytsia
ZIP/Postal Code
21005
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

A Study of Paliperidone Palmitate 6-Month Formulation

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