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A Study of Transition to the Paliperidone Palmitate 3-Month Formulation In Participants With Schizophrenia Previously Stabilized on the Paliperidone Palmitate 1-Month Formulation

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Paliperidone palmitate 3 month formulation (PP3M)
Sponsored by
Janssen-Cilag Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, R092670, Paliperidone Palmitate

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Meets Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) criteria for a diagnosis of schizophrenia
  • 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:

  • His/her psychiatric diagnosis is due to direct pharmacological effects of a substance (example, a drug of abuse or medication) or a general medical condition (example, clinically notable hypothyroidism, organic brain disorder)
  • 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paliperidone palmitate 3 month formulation (PP3M)

Arm Description

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.

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving Symptomatic Remission Based on Positive and Negative Syndrome Scale (PANSS)
The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent), 2 (minimal), 3 (mild), 4 (moderate), 5 (moderately severe), 6 (severe) and 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity. Symptomatic remission is defined as achieving intensity level of mild or moderate on PANSS scale by all 8 items as the determinants for symptomatic remission: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, lack of spontaneity.

Secondary Outcome Measures

Percentage of Participants Achieving Symptomatic Remission Based on Positive and Negative Syndrome Scale (PANSS) at Month 6, 9 and 12
PANSS is a 30-item scale to assess neuropsychiatric symptoms of schizophrenia. PANSS provides a total score and scores for 3 subscales, positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items), each item scored on a scale of 1 (absent), 2 (minimal), 3 (mild), 4 (moderate), 5 (moderately severe), 6 (severe) and 7 (extreme). Total score ranges from 30 to 210 and higher score indicates greater severity. Symptomatic remission is defined as achieving intensity level of mild or moderate on PANSS scale by all 8 items as the determinants for symptomatic remission: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, lack of spontaneity with the achieved intensity level maintained for at least 6 months.
Time to Symptomatic Remission
Time to Symptomatic Remission will be reported. Symptomatic remission is defined as achieving intensity level of mild or moderate on PANSS scale by all 8 items as the determinants for symptomatic remission: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, lack of spontaneity with the achieved intensity level maintained for at least 6 months.
Percentage of Participants who Meet the Remission Severity Criteria
Remission severity criteria that is, a score of mild or less [less than or equal to 3] on all selected PANSS items [P1, P2, P3, N1, N4, N6, G5, and G9]) at each time point.
Non-Inferiority of Change in PANSS Total Score From Baseline to Month 12 last-observation-carried-forward (LOCF)
Maintained efficacy will be investigated using the Schuirmann's test to test the change at last-observation-carried-forward (LOCF) endpoint in total PANSS score at endpoint versus baseline with a non-inferiority margin of 5 points on the PANSS scale.
The proportion of subjects with PANSS response
The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent), 2 (minimal), 3 (mild), 4 (moderate), 5 (moderately severe), 6 (severe) and 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity.

Full Information

First Posted
March 15, 2016
Last Updated
April 17, 2019
Sponsor
Janssen-Cilag Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02713282
Brief Title
A Study of Transition to the Paliperidone Palmitate 3-Month Formulation In Participants With Schizophrenia Previously Stabilized on the Paliperidone Palmitate 1-Month Formulation
Official Title
A 52-Week, Open-Label, Prospective, Multicenter, International Study of a Transition to the Paliperidone Palmitate 3-Month Formulation In Patients With Schizophrenia Previously Stabilized on the Paliperidone Palmitate 1-Month Formulation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 28, 2016 (Actual)
Primary Completion Date
March 26, 2018 (Actual)
Study Completion Date
March 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen-Cilag Ltd.

4. Oversight

Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to estimate the proportion of participants fulfilling criteria for symptomatic remission following a transition to 12 months treatment with flexible-dose paliperidone palmitate 3 month formulation (PP3M) in participants with schizophrenia previously adequately treated with paliperidone palmitate 1 month formulation (PP1M) for at least 4 months.
Detailed Description
This is an international, multicenter (study conducted at multiple sites) study designed to estimate remission rates and assess treatment response, tolerability, and patterns of use of Paliperidone Palmitate 3-Month Formulation (PP3M) in a diverse population of participants with schizophrenia. The study will consist of a screening phase (Day -7 to Day 1), a 52-week, open-label, flexible-dose PP3M treatment phase and a follow up safety assessment 3 months ( +/-14 days ) after the month 12 visit or early discontinuation. Participants' Safety will be monitored throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, R092670, Paliperidone Palmitate

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Paliperidone palmitate 3 month formulation (PP3M)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Paliperidone palmitate 3 month formulation (PP3M)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Symptomatic Remission Based on Positive and Negative Syndrome Scale (PANSS)
Description
The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent), 2 (minimal), 3 (mild), 4 (moderate), 5 (moderately severe), 6 (severe) and 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity. Symptomatic remission is defined as achieving intensity level of mild or moderate on PANSS scale by all 8 items as the determinants for symptomatic remission: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, lack of spontaneity.
Time Frame
Month 12
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving Symptomatic Remission Based on Positive and Negative Syndrome Scale (PANSS) at Month 6, 9 and 12
Description
PANSS is a 30-item scale to assess neuropsychiatric symptoms of schizophrenia. PANSS provides a total score and scores for 3 subscales, positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items), each item scored on a scale of 1 (absent), 2 (minimal), 3 (mild), 4 (moderate), 5 (moderately severe), 6 (severe) and 7 (extreme). Total score ranges from 30 to 210 and higher score indicates greater severity. Symptomatic remission is defined as achieving intensity level of mild or moderate on PANSS scale by all 8 items as the determinants for symptomatic remission: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, lack of spontaneity with the achieved intensity level maintained for at least 6 months.
Time Frame
Month 6, Month 9 , and Month 12
Title
Time to Symptomatic Remission
Description
Time to Symptomatic Remission will be reported. Symptomatic remission is defined as achieving intensity level of mild or moderate on PANSS scale by all 8 items as the determinants for symptomatic remission: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, lack of spontaneity with the achieved intensity level maintained for at least 6 months.
Time Frame
Up to Month 12
Title
Percentage of Participants who Meet the Remission Severity Criteria
Description
Remission severity criteria that is, a score of mild or less [less than or equal to 3] on all selected PANSS items [P1, P2, P3, N1, N4, N6, G5, and G9]) at each time point.
Time Frame
Up to Month 12
Title
Non-Inferiority of Change in PANSS Total Score From Baseline to Month 12 last-observation-carried-forward (LOCF)
Description
Maintained efficacy will be investigated using the Schuirmann's test to test the change at last-observation-carried-forward (LOCF) endpoint in total PANSS score at endpoint versus baseline with a non-inferiority margin of 5 points on the PANSS scale.
Time Frame
Up to Month 12
Title
The proportion of subjects with PANSS response
Description
The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent), 2 (minimal), 3 (mild), 4 (moderate), 5 (moderately severe), 6 (severe) and 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity.
Time Frame
Up to Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meets Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) criteria for a diagnosis of schizophrenia 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: His/her psychiatric diagnosis is due to direct pharmacological effects of a substance (example, a drug of abuse or medication) or a general medical condition (example, clinically notable hypothyroidism, organic brain disorder) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen-Cilag Limited Clinical Trial
Organizational Affiliation
Janssen-Cilag Limited
Official's Role
Study Director
Facility Information:
City
Rijeka
Country
Croatia
City
Zagreb
Country
Croatia
City
Esbjerg
Country
Denmark
City
Clermont Ferrand
Country
France
City
Montpellier
Country
France
City
Paris
Country
France
City
Rennes
Country
France
City
Toulon
Country
France
City
Berlin
Country
Germany
City
Hamburg
Country
Germany
City
Oranienburg
Country
Germany
City
Stralsund
Country
Germany
City
Athens
Country
Greece
City
Heraklion
Country
Greece
City
Nea Kifissia
Country
Greece
City
Thessaloniki
Country
Greece
City
Beer Yaakov
Country
Israel
City
Ramat Gan
Country
Israel
City
Gwangju
Country
Korea, Republic of
City
Jeonju
Country
Korea, Republic of
City
Seongnam
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of
City
Ipoh
Country
Malaysia
City
Johor Bahru
Country
Malaysia
City
Kuala Lumpur
Country
Malaysia
City
Assen
Country
Netherlands
City
Groningen
Country
Netherlands
City
Moscow
Country
Russian Federation
City
St-Petersburg
Country
Russian Federation
City
Jedda
Country
Saudi Arabia
City
Bilbao
Country
Spain
City
Madrid
Country
Spain
City
Oviedo
Country
Spain
City
Sabadell
Country
Spain
City
Torrevieja
Country
Spain
City
Valencia
Country
Spain
City
New Taipei City
Country
Taiwan
City
Tainan
Country
Taiwan
City
Taoyuan
Country
Taiwan
City
Ankara
Country
Turkey
City
Bursa
Country
Turkey
City
Istanbul
Country
Turkey
City
Sakarya
Country
Turkey
City
Derby
Country
United Kingdom
City
Edinburgh
Country
United Kingdom
City
Reading
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
35186258
Citation
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.
Results Reference
derived
Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-004835-10/results
Description
Related Info

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A Study of Transition to the Paliperidone Palmitate 3-Month Formulation In Participants With Schizophrenia Previously Stabilized on the Paliperidone Palmitate 1-Month Formulation

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