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| ID | Type | Description | Link |
|---|---|---|---|
| R092670PSY3011 | Other Identifier | Janssen Research & Development, LLC | |
| 2011-004889-15 | EudraCT Number | ||
| U1111-1135-7054 | Other Identifier | Universal Trial Number |
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The purpose of this study is to demonstrate that a paliperidone palmitate 3 month formulation (PP3M) is as effective as the paliperidone palmitate 1 month formulation (PP1M) in the treatment of patients with schizophrenia who have been stabilized on PP1M.
This is a randomized (the study drug is assigned by chance), double blind (neither physician nor patient knows the treatment that the patient receives), parallel group (each group of patients will be treated at the same time), multicenter non-inferiority (the effect of the new treatment is not worse than that of the comparison treatment) study. A new formulation of paliperidone palmitate with a 3-month injection interval (PP3M) is being tested for use as maintenance treatment for subjects with schizophrenia who have been first stabilized on paliperidone palmitate with a 1-month injection interval (PP1M). The study consists of 3 phases: a screening/washout/tolerability phase (up to 21 days); a 17-week open-label (all people know the identity of the intervention) stabilization phase (referred to as the Open-label Phase) and a 48-week fixed dose, randomized, double-blind controlled phase (referred to as the Double-blind Phase). After completion of the Screening Phase, all patients will receive PP1M in the Open-label Phase. During this time, flexible dosing will occur at Weeks 5 and 9. At Week 13 patients are to receive the dose of PP1M that was administered at Week 9. Patients who are clinically stable at the end of the Open-label Phase will enter the Double-blind Phase and will be randomly assigned in a 1:1 ratio to receive fixed doses of PP3M or PP1M.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paliperidone palmitate 3-month (PP3M) | Experimental | A formulation of paliperidone palmitate with a 3-month injection interval |
|
| Paliperidone palmitate 1-month (PP1M) | Active Comparator | A formulation of paliperidone palmitate with a 1-month injection interval |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PP3M 175 mg eq. | Drug | Type= exact number, unit= mg eq., number= 175, form= injection, route= intramuscular use. One injection every third month for 48 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Without Relapse at Week 48 During the Double-Blind Phase | Relapse defined as: Psychiatric hospitalization;participant had an increase of 25 percent in total PANSS score from randomization for 2 consecutive assessments separated by 3-7 days if score at randomization was greater than (>) 40; had a 10 point increase in total PANSS score from randomization for 2 consecutive assessments separated by 3-7 days if score at randomization was less than or equal to (<=) 40; deliberate self-injury or exhibited violent behavior resulting in suicide, clinically significant injury;suicidal or homicidal ideation and aggressive behavior;For PANSS items-had a score of greater than or equal to (>=) 5 after randomization for 2 consecutive assessments separated by 3-7 days on any of above items if maximum score for these above PANSS items was <=3 at randomization; had a score of >=6 after randomization for 2 consecutive assessments separated by 3-7 days on any of above items if maximum score for these above PANSS items was 4 at randomization. | Up to 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Double-Blind (DB) Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48 | The neuropsychiatric symptoms of schizophrenia were assessed by means of the 30-item Positive and Negative Syndrome Scale (PANSS). The PANSS provides a total score (sum of the scores of all 30 items) ranging from 30 to 210, higher scores indicate more severe neuropsychiatric symptoms of schizophrenia. Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock | Arkansas | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38190077 | Derived | Li X, Ye C, Zhang W, Jia M, Wang G. Factors Associated with Symptom Stabilization that Allow for Successful Transition from Once-Monthly Paliperidone Palmitate to Three-Monthly Paliperidone Palmitate: A Post Hoc Analysis Examined Clinical Characteristics in Chinese Patients with Schizophrenia. CNS Drugs. 2024 Jan;38(1):55-65. doi: 10.1007/s40263-023-01056-x. Epub 2024 Jan 8. | |
| 32184607 |
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1429 participants received at least 1 dose of the study agent in the Open-label Phase, out of which 1016 participants were randomized into the Double blind Phase (Safety population).
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| ID | Title | Description |
|---|---|---|
| FG000 | Open-Label: Paliperidone Palmitate (PP1M) 1-month Formulation | Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a dose of 150 milligram equivalent (mg eq.) on Day 1 and 100 mg eq. on Day 8, both as an injection in the deltoid muscle. The injections at Week 5 (Day 36) and Week 9 (Day 64) given in either the deltoid or gluteal muscle and were flexibly dosed (50, 75, 100, or 150 mg eq.). At Week 13 (Day 92) participants received the same dose of PP1M that was administered at Week 9. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Open Label Phase |
|
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| PP3M 263 mg eq. | Drug | Type= exact number, unit= mg eq., number= 263, form= injection, route= intramuscular use. One injection every third month for 48 weeks. |
|
| PP3M 350 mg eq. | Drug | Type= exact number, unit= mg eq., number= 350, form= injection, route= intramuscular use. One injection every third month for 48 weeks. |
|
| PP3M 525 mg eq. | Drug | Type= exact number, unit= mg eq., number= 525, form= injection, route= intramuscular use. One injection every third month for 48 weeks. |
|
| Placebo (20% Intralipid) | Drug | Form= injection, route= intramuscular use. One injection monthly when not receiving active medication for 48 weeks. |
|
| PP1M 50 mg eq. | Drug | Type= exact number, unit= mg eq., number= 50, form= injection, route= intramuscular use. One injection every month for 48 weeks. |
|
| PP1M 75 mg eq. | Drug | Type= exact number, unit= mg eq., number= 75, form= injection, route= intramuscular use. One injection every month for 48 weeks. |
|
| PP1M 100 mg eq. | Drug | Type= exact number, unit= mg eq., number= 100, form= injection, route= intramuscular use. One injection every month for 48 weeks. |
|
| PP1M 150 mg eq. | Drug | Type= exact number, unit= mg eq., number= 150, form= injection, route= intramuscular use. One injection every month for 48 weeks. |
|
| DB Baseline (Week 17) and 48 week or DB Endpoint |
| Change From DB Baseline in Clinical Global Impression Severity (CGI-S) Scale Score at Week 48 | The Clinical Global Impression Severity (CGI-S) rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening. | DB Baseline (Week 17) and 48 week or DB Endpoint |
| Change From DB Baseline in Personal and Social Performance (PSP) Total Score at Week 48 | The Personal and Social Performance (PSP) scale assesses degree of a participant's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100. Participants with a score of 71 to 100 have 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. | DB Baseline (Week 17) and 48 week or DB Endpoint |
| Percentage of Participants Who Met the Criteria for Symptomatic Remission Based on Andreasen Criteria | Symptomatic remission criterion was defined as having a simultaneous score of mild or less on all selected PANSS items (P1, P2, P3, N1, N4, N6, G5, and G9). Symptomatic remission was defined for the last 6 months of the Double-blind Phase as meeting the remission criterion during the 6 months prior to the End of study visit during the Double-blind Phase, with one excursion allowed. | Weeks 41 to 65 |
| Change From Baseline in Positive and Negative Syndrome Subscales Score at Week 48 | The neuropsychiatric symptoms of schizophrenia were assessed by means of the 30-item Positive and Negative Syndrome Scale (PANSS). The PANSS provides a total score (sum of the scores of all 30 items) ranging from 30 to 210, higher scores indicate more severe neuropsychiatric symptoms of schizophrenia. Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology). | DB Baseline (Week 17) and 48 week or DB Endpoint |
| Change From Baseline in Marder Factor Subscale Score at Week 48 | 5 PANSS Marder factor scores (positive symptoms [range:8 to 56], negative symptoms [range: 7 to 49], disorganized thoughts [range: 7 to 49], uncontrolled hostility/excitement [range: 4 to 28], and anxiety/depression [range: 4 to 28]) were examined to gain insight into the symptoms affected by treatment with the study drug. Negative change from baseline in subscales score for positive symptoms, negative symptoms, disorganized thoughts, uncontrolled hostility/excitement, and anxiety/depression indicates improvement in various symptoms of schizophrenia. | DB Baseline (Week 17) and 48 week or DB Endpoint |
| Glendale |
| California |
| United States |
| Long Beach | California | United States |
| Oakland | California | United States |
| Oceanside | California | United States |
| Orange | California | United States |
| San Diego | California | United States |
| New Britain | Connecticut | United States |
| Bradenton | Florida | United States |
| Kissimmee | Florida | United States |
| Tampa | Florida | United States |
| Wichita | Kansas | United States |
| East Lansing | Michigan | United States |
| St Louis | Missouri | United States |
| Las Vegas | Nevada | United States |
| Jamaica | New York | United States |
| Durham | North Carolina | United States |
| Canton | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Philadelphia | Pennsylvania | United States |
| Charleston | South Carolina | United States |
| Memphis | Tennessee | United States |
| Austin | Texas | United States |
| Bothell | Washington | United States |
| Buenos Aires | Argentina |
| Córdoba | Argentina |
| Rosario | Argentina |
| Elizabeth Vale | Australia |
| Frankston | Australia |
| Innsbruck | Austria |
| Assebroek | Belgium |
| Bertrix | Belgium |
| Dave | Belgium |
| Heusden | Belgium |
| Jette | Belgium |
| Marchienne-au-Pont | Belgium |
| Sint-Denijs-Westrem | Belgium |
| Rio de Janeiro | Brazil |
| Burgas | Bulgaria |
| Kazanlak | Bulgaria |
| Radnevo | Bulgaria |
| Sofia | Bulgaria |
| Calgary | Alberta | Canada |
| Halifax | Ontario | Canada |
| Montreal | Quebec | Canada |
| Burlington | Canada |
| Baoding | China |
| Beijing | China |
| Changsha | China |
| Guangdong | China |
| Guangzhou | China |
| Hangzhou | China |
| Kunming | China |
| Shanghai | China |
| Tianjin | China |
| Wuhan | China |
| Xi'an | China |
| Brno | Czechia |
| Hořovice | Czechia |
| Liberec | Czechia |
| Prague | Czechia |
| Přerov | Czechia |
| Clermont-Ferrand | France |
| Dole | France |
| Montpellier | France |
| Toulon | France |
| Bochum | Germany |
| Gelsenkirchen | Germany |
| Hamburg | Germany |
| Heidelberg | Germany |
| München | Germany |
| Arta | Greece |
| Athens | Greece |
| Katerini | Greece |
| Balassagyarmat | Hungary |
| Budapest | Hungary |
| Gyõr | Hungary |
| Kalocsa | Hungary |
| Sopron | Hungary |
| Aizu-Wakamatsu | Japan |
| Fujioka | Japan |
| Fujisawa | Japan |
| Hadano | Japan |
| Himeji | Japan |
| Hitachi | Japan |
| Ichikawa | Japan |
| Kanuma | Japan |
| Kanzaki | Japan |
| Kashihara | Japan |
| Kashiwara | Japan |
| Kasuya | Japan |
| Kawasaki | Japan |
| Kitagunma | Japan |
| Kochi | Japan |
| Kodaira | Japan |
| Kumagaya | Japan |
| Kumamoto | Japan |
| Kure | Japan |
| Matsusaka | Japan |
| Mitaka | Japan |
| Moriguchi | Japan |
| Nagasaki | Japan |
| Naha | Japan |
| Nirasaki | Japan |
| Ohta | Japan |
| Okayama | Japan |
| Okinawa | Japan |
| Sakai | Japan |
| Shibukawa | Japan |
| Takatsuki | Japan |
| Toki | Japan |
| Tokushima | Japan |
| Tokyo | Japan |
| Toyoake | Japan |
| Ueda | Japan |
| Yatsushiro | Japan |
| Yokkaichi | Japan |
| Yokohama | Japan |
| Guadalajara | Mexico |
| Monterrey | Mexico |
| Tlalnepantla | Mexico |
| Bełchatów | Poland |
| Bydgoszcz | Poland |
| Chełmno | Poland |
| Gdynia Na | Poland |
| Lubin | Poland |
| Lubliniec | Poland |
| Piekary Śląskie | Poland |
| Torun | Poland |
| Ząbki | Poland |
| Almada | Portugal |
| Angra do Heroísmo | Portugal |
| Coimbra | Portugal |
| Lisbon | Portugal |
| Porto | Portugal |
| Brasov | Romania |
| Cluj-Napoca | Romania |
| Arkhangelsk | Russia |
| Gatchina | Russia |
| Krasnodar | Russia |
| Moscow | Russia |
| Nizhny Novgorod | Russia |
| Saint Petersburg | Russia |
| Saratov | Russia |
| Smolensk | Russia |
| Smolensk Region N/A | Russia |
| St-Peterburg | Russia |
| Tomsk Na | Russia |
| Yaroslavl | Russia |
| Yekaterinburg | Russia |
| Bratislava | Slovakia |
| Michalovce | Slovakia |
| Rimavská Sobota | Slovakia |
| Trenčín | Slovakia |
| Busan | South Korea |
| Gwangju | South Korea |
| Gyeonggi-do | South Korea |
| Seoul | South Korea |
| Alicante | Spain |
| Barakaldo | Spain |
| Barcelona | Spain |
| Coslada | Spain |
| Elche | Spain |
| Madrid | Spain |
| Zamora | Spain |
| Uppsala | Sweden |
| Bali Township, Taipei County | Taiwan |
| Kaohsiung City | Taiwan |
| Taoyuan | Taiwan |
| Hlevakha | Ukraine |
| Kharkiv | Ukraine |
| Kiev | Ukraine |
| Odesa | Ukraine |
| Poltava | Ukraine |
| Derived |
| Gopal S, Gogate J, Pungor K, Kim E, Singh A, Mathews M. Improvement of Negative Symptoms in Schizophrenia with Paliperidone Palmitate 1-Month and 3-Month Long-Acting Injectables: Results from a Phase 3 Non-Inferiority Study. Neuropsychiatr Dis Treat. 2020 Mar 6;16:681-690. doi: 10.2147/NDT.S226296. eCollection 2020. |
| 30994855 | Derived | Savitz AJ, Xu H, Gopal S, Nuamah I, Mathews M, Soares B. Efficacy and safety of paliperidone palmitate 3-month formulation in Latin American patients with schizophrenia: A subgroup analysis of data from two large phase 3 randomized, double-blind studies. Braz J Psychiatry. 2019 Nov-Dec;41(6):499-510. doi: 10.1590/1516-4446-2018-0153. |
| 30962688 | Derived | Nash AI, Turkoz I, Savitz AJ, Mathews M, Kim E. Predictors of achieving remission in schizophrenia patients treated with paliperidone palmitate 3-month formulation. Neuropsychiatr Dis Treat. 2019 Mar 22;15:731-737. doi: 10.2147/NDT.S194264. eCollection 2019. |
| 29882073 | Derived | Mathews M, Pei H, Savitz A, Nuamah I, Hough D, Alphs L, Gopal S. Paliperidone Palmitate 3-Monthly Versus 1-Monthly Injectable in Patients With Schizophrenia With or Without Prior Exposure to Oral Risperidone or Paliperidone: A Post Hoc, Subgroup Analysis. Clin Drug Investig. 2018 Aug;38(8):695-702. doi: 10.1007/s40261-018-0647-z. |
| 27743205 | Derived | Magnusson MO, Samtani MN, Plan EL, Jonsson EN, Rossenu S, Vermeulen A, Russu A. Population Pharmacokinetics of a Novel Once-Every 3 Months Intramuscular Formulation of Paliperidone Palmitate in Patients with Schizophrenia. Clin Pharmacokinet. 2017 Apr;56(4):421-433. doi: 10.1007/s40262-016-0459-3. |
| 27333588 | Derived | Samtani MN, Nandy P, Ravenstijn P, Remmerie B, Vermeulen A, Russu A, D'hoore P, Baum EZ, Savitz A, Gopal S, Hough D. Prospective dose selection and acceleration of paliperidone palmitate 3-month formulation development using a pharmacometric bridging strategy. Br J Clin Pharmacol. 2016 Nov;82(5):1364-1370. doi: 10.1111/bcp.13050. Epub 2016 Jul 24. |
| FG001 | Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation | Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle. |
| FG002 | Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation | Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle. |
| COMPLETED |
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| NOT COMPLETED |
|
|
| DOUBLE BLIND |
|
|
The safety analysis set included all participants who were randomly assigned to treatment during the Double-blind Phase and received at least 1 dose study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation | Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle. |
| BG001 | Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation | Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Without Relapse at Week 48 During the Double-Blind Phase | Relapse defined as: Psychiatric hospitalization;participant had an increase of 25 percent in total PANSS score from randomization for 2 consecutive assessments separated by 3-7 days if score at randomization was greater than (>) 40; had a 10 point increase in total PANSS score from randomization for 2 consecutive assessments separated by 3-7 days if score at randomization was less than or equal to (<=) 40; deliberate self-injury or exhibited violent behavior resulting in suicide, clinically significant injury;suicidal or homicidal ideation and aggressive behavior;For PANSS items-had a score of greater than or equal to (>=) 5 after randomization for 2 consecutive assessments separated by 3-7 days on any of above items if maximum score for these above PANSS items was <=3 at randomization; had a score of >=6 after randomization for 2 consecutive assessments separated by 3-7 days on any of above items if maximum score for these above PANSS items was 4 at randomization. | Modified intent-to-treat (mITT) analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure. | Posted | Number | Percentage of Participants | Up to 48 weeks |
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| Secondary | Change From Double-Blind (DB) Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48 | The neuropsychiatric symptoms of schizophrenia were assessed by means of the 30-item Positive and Negative Syndrome Scale (PANSS). The PANSS provides a total score (sum of the scores of all 30 items) ranging from 30 to 210, higher scores indicate more severe neuropsychiatric symptoms of schizophrenia. Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology). | mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | DB Baseline (Week 17) and 48 week or DB Endpoint |
| ||||||||||||||||||||||||||||||
| Secondary | Change From DB Baseline in Clinical Global Impression Severity (CGI-S) Scale Score at Week 48 | The Clinical Global Impression Severity (CGI-S) rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening. | mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | DB Baseline (Week 17) and 48 week or DB Endpoint |
| ||||||||||||||||||||||||||||||
| Secondary | Change From DB Baseline in Personal and Social Performance (PSP) Total Score at Week 48 | The Personal and Social Performance (PSP) scale assesses degree of a participant's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100. Participants with a score of 71 to 100 have 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. | mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | DB Baseline (Week 17) and 48 week or DB Endpoint |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Met the Criteria for Symptomatic Remission Based on Andreasen Criteria | Symptomatic remission criterion was defined as having a simultaneous score of mild or less on all selected PANSS items (P1, P2, P3, N1, N4, N6, G5, and G9). Symptomatic remission was defined for the last 6 months of the Double-blind Phase as meeting the remission criterion during the 6 months prior to the End of study visit during the Double-blind Phase, with one excursion allowed. | mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure. | Posted | Number | Percentage of Participants | Weeks 41 to 65 |
| |||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Positive and Negative Syndrome Subscales Score at Week 48 | The neuropsychiatric symptoms of schizophrenia were assessed by means of the 30-item Positive and Negative Syndrome Scale (PANSS). The PANSS provides a total score (sum of the scores of all 30 items) ranging from 30 to 210, higher scores indicate more severe neuropsychiatric symptoms of schizophrenia. Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology). | mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | DB Baseline (Week 17) and 48 week or DB Endpoint |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Marder Factor Subscale Score at Week 48 | 5 PANSS Marder factor scores (positive symptoms [range:8 to 56], negative symptoms [range: 7 to 49], disorganized thoughts [range: 7 to 49], uncontrolled hostility/excitement [range: 4 to 28], and anxiety/depression [range: 4 to 28]) were examined to gain insight into the symptoms affected by treatment with the study drug. Negative change from baseline in subscales score for positive symptoms, negative symptoms, disorganized thoughts, uncontrolled hostility/excitement, and anxiety/depression indicates improvement in various symptoms of schizophrenia. | mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | DB Baseline (Week 17) and 48 week or DB Endpoint |
|
From signing of informed consent form up to Follow-Up Visit (4 or 12 Weeks after study drug administration)
For Double-blind (DB) phase, safety analysis set included all participants who were randomly assigned to treatment during DB Phase and received at least 1 dose of DB study drug. For Open-label Phase, all participants who received at least 1 dose of open-label study drug and were included in summary of safety assessments for that phase.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open-Label: Paliperidone Palmitate (PP1M) 1-month Formulation | Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a dose of 150 milligram equivalent (mg eq.) on Day 1 and 100 mg eq. on Day 8, both as an injection in the deltoid muscle. The injections at Week 5 (Day 36) and Week 9 (Day 64) given in either the deltoid or gluteal muscle and were flexibly dosed (50, 75, 100, or 150 mg eq.). At Week 13 (Day 92) participants received the same dose of PP1M that was administered at Week 9. | 101 | 1,429 | 457 | 1,429 | ||
| EG001 | Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation | Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle. | 26 | 504 | 212 | 504 | ||
| EG002 | Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation | Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle. | 37 | 512 | 208 | 512 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Gastrointestinal Disorder | Gastrointestinal disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Pancreatitis Acute | Gastrointestinal disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Drug Ineffective | General disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Drug Withdrawal Syndrome | General disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Meningitis Bacterial | Infections and infestations | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Pyelonephritis Acute | Infections and infestations | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Alcohol Poisoning | Injury, poisoning and procedural complications | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Head Injury | Injury, poisoning and procedural complications | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Meniscus Injury | Injury, poisoning and procedural complications | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Toxicity to Various Agents | Injury, poisoning and procedural complications | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Diabetic Ketoacidosis | Metabolism and nutrition disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Muscle Rigidity | Musculoskeletal and connective tissue disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Hepatocellular Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Neoplasm Prostate | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Akathisia | Nervous system disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Stupor | Nervous system disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Acute Psychosis | Psychiatric disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Adjustment Disorder | Psychiatric disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Alcohol Abuse | Psychiatric disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Anxiety Disorder | Psychiatric disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Delusion | Psychiatric disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Depressed Mood | Psychiatric disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Hallucination, Auditory | Psychiatric disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Hostility | Psychiatric disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Hypomania | Psychiatric disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Neurosis | Psychiatric disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Persecutory Delusion | Psychiatric disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Psychiatric Symptom | Psychiatric disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Psychotic Disorder | Psychiatric disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Schizophrenia, Paranoid Type | Psychiatric disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Self Injurious Behaviour | Psychiatric disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Substance-Induced Psychotic Disorder | Psychiatric disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Suicidal Ideation | Psychiatric disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Suicide Attempt | Psychiatric disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Tension | Psychiatric disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Calculus Ureteric | Renal and urinary disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Menstrual Disorder | Reproductive system and breast disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Peripheral Artery Thrombosis | Vascular disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA Version 17.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Induration | General disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Injection Site Pain | General disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Weight Increased | Investigations | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Akathisia | Nervous system disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 17.1 | Non-systematic Assessment |
|
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director Clinical Research | Janssen Research & Development, LLC | ClinicalTrialDisclosure@its.jnj.com |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C545823 | soybean oil, phospholipid emulsion |
Not provided
Not provided
Not provided
| Lost to Follow-up |
|
| Pregnancy |
|
| Withdrawal by Subject |
|
| Other |
|
| Blind broken by investigator |
|
| Male |
|
| Russian Federation |
|
| Japan |
|
| United States |
|
| Ukraine |
|
| Czech Republic |
|
| Hungary |
|
| Poland |
|
| Argentina |
|
| Bulgaria |
|
| Brazil |
|
| Spain |
|
| Slovakia |
|
| Portugal |
|
| Mexico |
|
| Taiwan |
|
| Romania |
|
| Germany |
|
| South Korea |
|
| Belgium |
|
| Greece |
|
| Canada |
|
| Australia |
|
| France |
|
| Austria |
|
| Double Blind: Paliperidone Palmitate 1 Month Formulation |
Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle. |
|
|
|
|
|
|
|
|
| Double Blind: Paliperidone Palmitate 1 Month Formulation |
Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle. |
|
|
Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle. |
|
|