Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
841 participants
INTERVENTIONAL
2017-11-20
2020-05-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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PP1M: Transition Phase
Participants who previously have not achieved stability with moderate to higher doses of Paliperidone palmitate 1-month (PP1M) or Paliperidone palmitate 3-month (PP3M) will enter into a transition period of up to 4 months. During transition period participants will receive 1 to 5 injections of PP1M 50 to 100 milligrams equivalent (mg eq.). The participants who achieved stability (stability is defined as at least 3 months of injections with the last 2 doses being the same strength) with PP1M 100 mg eq. will precede from transition phase to maintenance phase.
PP1M
Participants will receive intramuscular injection of PP1M 50 to 150 mg eq.
PP1M/PP3M: Maintenance Phase
All the participants will receive only 1 dose of PP1M 100 or 150 mg eq. or PP3M 350 or 525 mg eq. The participants will precede from maintenance phase to double-blind phase.
PP3M 350 mg eq.
Participants will receive intramuscular injection of PP3M 350 mg eq.
PP3M 525 mg eq.
Participants will receive intramuscular injection of PP3M 525 mg eq.
PP1M
Participants will receive intramuscular injection of PP1M 50 to 150 mg eq.
PP6M or Placebo: Double-Blind Phase
Participants will receive intramuscular injection of PP6M in left gluteal muscle on Day 1 and right gluteal muscle on Day 183 with alternating placebo in right gluteal muscle on Day 92 and left gluteal muscle on Day 274.
PP6M
Participants will receive intramuscular injection of PP6M.
Placebo
Participants will receive matching placebo.
PP3M: Double-Blind Phase
Participants will receive intramuscular injections of PP3M at dose of 350 mg eq. or 525 mg eq. in left gluteal muscle on Day 1 and 274 and right gluteal muscle on Day 92 and 183.
PP3M 350 mg eq.
Participants will receive intramuscular injection of PP3M 350 mg eq.
PP3M 525 mg eq.
Participants will receive intramuscular injection of PP3M 525 mg eq.
Interventions
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PP6M
Participants will receive intramuscular injection of PP6M.
PP3M 350 mg eq.
Participants will receive intramuscular injection of PP3M 350 mg eq.
PP3M 525 mg eq.
Participants will receive intramuscular injection of PP3M 525 mg eq.
PP1M
Participants will receive intramuscular injection of PP1M 50 to 150 mg eq.
Placebo
Participants will receive matching placebo.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must be receiving treatment with paliperidone palmitate (as either the paliperidone palmitate 1-month (PP1M) or paliperidone palmitate 3-month (PP3M) formulation), or injectable risperidone, or any oral antipsychotic
* Must be able, in the opinion of the investigator, to discontinue any antipsychotic medication other than PP1M) or PP3M during the Screening Phase
* Must have a full Positive and Negative Syndrome Scale (PANSS) score of less than (\<) 70 points at screening
* Must have a body mass index (BMI) between 17 and 40 kilogram (kg)/meter (m)\^2 (inclusive) and must have a body weight of at least 47 kg at screening
* Must be willing to receive gluteal injections of medication during the Double-blind Phase
Exclusion Criteria
* Must not have attempted suicide within 12 months before screening and must not be at imminent risk of suicide or violent behavior, as clinically assessed by the investigator at the time of screening
* Must not have a DSM-5 diagnosis of moderate or severe substance use disorder (except for nicotine and caffeine) within 6 months of screening; however, acute or intermittent substance use prior to screening is not exclusionary, depending upon the clinical judgment of the investigator
* Must not have a history of neuroleptic malignant syndrome or tardive dyskinesia
* Must not have a history of intolerability or severe reactions to moderate or higher doses of antipsychotic medications and must not have any other factors that would, in the judgment of the investigator, indicate that treatment with moderate or higher doses of paliperidone palmitate would be intolerable or unsafe
18 Years
70 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Woodland Research Northwest
Rogers, Arkansas, United States
California Pharmaceutical Research Institute, Inc.
Anaheim, California, United States
ATP Clinical Research
Costa Mesa, California, United States
Collaborative NeuroScience Network
Garden Grove, California, United States
Synergy East
Lemon Grove, California, United States
Pacific Research Partners
Oakland, California, United States
SF-Care, Inc
San Rafael, California, United States
New Life Medical Research Center, Inc.
Hialeah, Florida, United States
Clintex Research Group
Miami, Florida, United States
Florida Research Center Inc.
Miami, Florida, United States
Olympian Clinical Research
Tampa, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Uptown Research Institute
Chicago, Illinois, United States
Alexian Behavioral Health Hospital
Hoffman Estates, Illinois, United States
Ascension via Christi Research
Wichita, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Cherry Street Services, Inc.
Grand Rapids, Michigan, United States
St. Louis Clinical Trials
St Louis, Missouri, United States
The Zucker Hillside Hospital
Glen Oaks, New York, United States
Clinical Trials of America Inc
Hickory, North Carolina, United States
Wexner Medical Center at the Ohio State University
Columbus, Ohio, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States
Future Search Trials of Dallas
Dallas, Texas, United States
Psychiatric and Behavioral Solutions
Salt Lake City, Utah, United States
Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales
Buenos Aires, , Argentina
CEN
Córdoba, , Argentina
Sanatorio Prof. Leon S. Morra
Córdoba, , Argentina
Instituto de Neurociencias San Agustin
La Plata, , Argentina
Clinica Privada de Salud Mental Santa Teresa de Ávila
La Plata, , Argentina
C I A P Centro de investigacion y Asistencia en Psiquiatria
Rosario, , Argentina
The Lyell McEwin Hospital
Elizabeth Vale, , Australia
Neuro Trials Victoria
Noble Park, , Australia
Trial Tech Tecnologia em Pesquisas com Medicamentos
Curitiba, , Brazil
Instituto Bairral de Psiquiatria
Itapira, , Brazil
Hospital das Clinicas de Porto Alegre
Porto Alegre, , Brazil
Ruschel Medicina e Pesquisa Clínica Ltda
Rio de Janeiro, , Brazil
CPQuali Pesquisa Clinica LTDA ME
São Paulo, , Brazil
SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo
São Paulo, , Brazil
Hospital Das Clinicas Da Faculdade De Medicina Da USP
São Paulo, , Brazil
Mental Health Center Prof. Dr. Ivan Temkov
Burgas, , Bulgaria
State Psychiatric Hospital Pazardzhik
Pazardzhik, , Bulgaria
UMHAT 'Sveti Georgi'-Plovdiv
Plovdiv, , Bulgaria
State Psychiatric HospitalDr.Georgi Kissiov
Radnevo, , Bulgaria
Centre for Mental Health Prof.N.Shipkovenski EOOD
Sofia, , Bulgaria
Medical Center Intermedica, OOD
Sofia, , Bulgaria
Psychiatricka ambulance, MUDr. Marta Holanova
Brno, , Czechia
NeuropsychiatrieHK, s.r.o.
Hradec Kralove-Vekose, , Czechia
A Shine S R O
Pilsen, , Czechia
Pragtis S R O
Prague, , Czechia
Institut Neuropsychiatricke pece
Prague, , Czechia
Psychiatricka ambulance MUDr. Simona Papezova
Prague, , Czechia
C.H.S. Charles Perrens
Bordeaux, , France
CHRU La Colombière
Montpellier, , France
CHU Caremeau
Nîmes, , France
Hopital Sainte Anne
Paris, , France
Hopital Sainte Musse
Toulon, , France
Kwai Chung Hospital
Hong Kong, , Hong Kong
Queen Mary Hospital
Hong Kong, , Hong Kong
Józsefvarosi Szent Kozma Egészségügyi Központ
Budapest, , Hungary
Petz Aladar Megyei Oktato Korhaz
Győr, , Hungary
Bács-Kiskun Megyei Kórház a Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza
Kalocsa, , Hungary
CRU Hungary Kft.
Miskolc, , Hungary
Ratandeep Multispeciality Hospital
Ahmedabad, , India
Sri Ramachandra Medical Centre
Chennai, , India
Asha hospital
Hyderabad, , India
Ahana Hospitals
Madurai, , India
Vinaya Hospital and Research Center
Mangalore, , India
Kasturba Medical College Hospital
Manipal, , India
Jehangir Clinical Development Center Pvt Ltd
Pune, , India
Deva Institute of Health Care and Research Pvt Ltd
Varanasi, , India
Clinica Psichiatrica - Università di Cagliari
Cagliari, , Italy
Dipartimento di Salute Mentale
Lecce, , Italy
Seconda Universita degli Studi di Napoli - Azienda Ospedaliera Universitaria
Napoli, , Italy
Universita degli Studi di Roma 'La Sapienza' - Azienda Ospedaliera Sant Andrea
Roma, , Italy
Hospital Bahagia Ulu Kinta
Ipoh, , Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, , Malaysia
University Malaya Medical Centre
Kuala Lumpur, , Malaysia
Sarawak General Hospital
Kuching, , Malaysia
Gabipros SC
Mexico City, , Mexico
Instituto Neuropsique
Monterrey, , Mexico
Centro de Estudios Clinicos y Especialidades Medicas S C
Monterrey, , Mexico
Infosame/Research
Monterrey, , Mexico
Centro de Atencion e Investigacion Cardiovascular del Potosi S C
San Luis Potosí City, , Mexico
Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk
Bialystok, , Poland
Wlokiennicza MED Specjalistyczna Praktyka Lekarska dr n.med. Tomasz Markowski
Bialystok, , Poland
Zespol Opieki Zdrowotnej w Chelmnie
Chełmno, , Poland
Centrum Badan Klinicznych PI House sp z o o
Gdansk, , Poland
Szpital Specjalistyczny im H Klimontowicza Oddzial Psychiatryczny
Gorlice, , Poland
Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
Leszno, , Poland
Centrum Medyczne Luxmed Sp z o o
Lublin, , Poland
Poradnia Zdrowia Psychicznego 'Syntonia' w Pruszczu Gdanskim
Pruszcz Gdański, , Poland
Mazowieckie Specjalistyczne Centrum Zdrowia im. Prof. Jana Mazurkiewicza w Pruszkowie
Pruszków, , Poland
Wojewodzki Szpital Zespolony im L Rydygiera w Toruniu
Torun, , Poland
Clinical Psychiatric Hospital #3 Named After V.A. Gilyarovsky
Moscow, , Russia
Psychiatric Clinical hospital 1 named after N.A. Alekseev
Moscow, , Russia
Nizny Novgorod clinical psychiatric hospital 1
Nizny Novgorod, , Russia
Psychoneurological Dispensary of Frunzensky District
Saint Petersburg, , Russia
Psychoneurological dispensary 10
Saint Petersburg, , Russia
St-Petersburg Bekhterev Psychoneurological Research Institute
Saint Petersburg, , Russia
Psychoneurological dispensary 1
Saint Petersburg, , Russia
SHI 'Saratov City Clinical Hospital 2 n.a V.I. Razumovsky
Saratov, , Russia
Saratov Regional Psychiatric hospital named after St. Sofia
Saratov, , Russia
Psychoneurological Dispensary #4
St.Peterburg, , Russia
Research Institute of Mental Health
Tomsk, , Russia
Sverdlovsk Regional Clinical Psychiatric Hospital
Yekaterinburg, , Russia
Flexivest 14 Research
Cape Town, , South Africa
Gert Bosch Pretoria South Africa
Pretoria, , South Africa
Juan Schrönen - Western Cape South Africa
Welgemoed, , South Africa
Chonnam National University Hospital
Gwangju, , South Korea
CHA Bundang Medical Center, CHA University
Gyeonggi-do, , South Korea
Chonbuk National Univ Hospital
Jeonju, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Hosp Univ Vall D Hebron
Barcelona, , Spain
Inst. Internac. Neurociencias Aplicadas
Barcelona, , Spain
Hosp. Univ. de Basurto
Bilbao, , Spain
Centro Salud Mental La Corredoria
Oviedo, , Spain
Hosp. El Bierzo
Ponferrada, , Spain
Hosp. Clinico Univ. de Valencia
Valencia, , Spain
Hosp. Prov. de Zamora
Zamora, , Spain
National Cheng Kung University Hospital
Tainan City, , Taiwan
Mackay Memorial Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Abdurrah Yurtarslan Training and Research Hospital
Ankara, , Turkey (Türkiye)
Ankara Numune Research and Training Hospital
Ankara, , Turkey (Türkiye)
Erenkoy Mental Health Hospital
Istanbul, , Turkey (Türkiye)
Selcuk University, Medical School, Department of Psychiatry
Konya, , Turkey (Türkiye)
Sakarya University Medical Faculty Psychiatry Department
Sakarya, , Turkey (Türkiye)
MNCE of Kyiv RC Regional Psychiatric and Narcological Medical Association
Hlevakha, , Ukraine
Mnpe of Kharkiv Regional Council 'Regional Clinical Psychiatric Hospital #3'
Kharkiv, , Ukraine
CNPE'Kherson Regional Institution of Mental Care'of Kherson Regional Council
Kherson, , Ukraine
Kyiv Territorial Medical Incorporation 'Psychiatry'
Kyiv, , Ukraine
Municipal Institution 'Lviv Regional Clinical Psycho-Neurological Dispensary'
Lviv, , Ukraine
CNCE of the Lviv Regional Council 'Lviv Regional Clinical Psychiatric Hospital'
Lviv, , Ukraine
CNCE Odesa regional psychiatric hospital #2 Odesa regional council
Oleksandrivka, , Ukraine
CNCE 'Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council'
Smila, , Ukraine
CNCE 'Vinnytsya RC Psychoneurological Hospital n.a. O.I. Yushchenko Vinnytsya RC'
Vinnytsia, , Ukraine
Countries
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References
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Richarz U, Han J, Bai YM, Yu-Hai Chen E, Chung YC, Jhanwar VG, Kim SW, Sulaiman AH, Knight K, Gopal S. Efficacy and safety of paliperidone palmitate 6-monthly long-acting injectable in reduction of relapses in patients with schizophrenia: An Asian subgroup analysis of phase 3, randomized study. Medicine (Baltimore). 2023 Aug 25;102(34):e34623. doi: 10.1097/MD.0000000000034623.
Najarian D, Turkoz I, Knight RK, Galderisi S, Lamaison HF, Zalitacz P, Aravind S, Richarz U. Long-Term Efficacy and Safety of Paliperidone 6-Month Formulation: An Open-Label 2-Year Extension of a 1-Year Double-Blind Study in Adult Participants With Schizophrenia. Int J Neuropsychopharmacol. 2023 Aug 29;26(8):537-544. doi: 10.1093/ijnp/pyad028.
Najarian D, Sanga P, Wang S, Lim P, Singh A, Robertson MJ, Cohen K, Schotte A, Milz R, Venkatasubramanian R, T'Jollyn H, Walling DP, Galderisi S, Gopal S. A Randomized, Double-Blind, Multicenter, Noninferiority Study Comparing Paliperidone Palmitate 6-Month Versus the 3-Month Long-Acting Injectable in Patients With Schizophrenia. Int J Neuropsychopharmacol. 2022 Mar 17;25(3):238-251. doi: 10.1093/ijnp/pyab071.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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R092670PSY3015
Identifier Type: OTHER
Identifier Source: secondary_id
2017-001941-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR108390
Identifier Type: -
Identifier Source: org_study_id
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