A Study of Paliperidone Palmitate 6-Month Formulation

NCT03345342 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: CR108390R092670PSY30152017-001941-28
• Study Type: interventional
• Target: 841
• Locations: 21 countries
• Sites: 138

Brief Summary

The purpose of this study is to demonstrate that injection cycles consisting of a single administration of paliperidone palmitate 6-month (PP6M) are not less effective than 2 sequentially administered injections of paliperidone palmitate 3-month PP3M) (350 or 525 mg eq.) for the prevention of relapse in participants with schizophrenia previously stabilized on corresponding doses of paliperidone palmitate 1-month (PP1M) (100 or 150 mg eq.) or PP3M (350 or 525 mg eq.).

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Time to Relapse During the Double-Blind (DB) Phase

  Time to relapse is time between participant randomization in DB Phase and first documentation of relapse event by end of Month 12 of DB phase. Relapse is defined as: a) Psychiatric hospitalization; b) Positive and Negative Syndrome Scale (PANSS) total score: Increase of 25 percentage (%), 10 point increase in PANSS for 2 analysis separated by 3-7 days if score was greater than (\>) 40, less than or equal to (\<=)40; c) Participants inflicted knowing self-injury/shown violent behavior leading to suicide, clinically significant injury to him/herself or other person/property; d) Participants had suicidal/homicidal ideation/violent behavior that was clinically significant as per investigator; e) PANSS items P1- delusions, P2- conceptual disorganization, P3-hallucinatory behavior, P6- suspiciousness/ persecution, P7-hostility, G8-uncooperativeness: score: greater than or equal to (\>=)5, \>=6 for 2 analysis separated by 3-7 days on any items if maximum score for PANSS: \<=3 or 4, respectively.

  Up to 12 months of DB Phase

Secondary Outcomes (19)

• Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score

  Baseline (DB) to 12 Months of DB Phase

• Change From Baseline in the Clinical Global Impression - Severity (CGI-S) Score

  Baseline (DB) to 12 Months of DB Phase

• Change From Baseline in the Personal and Social Performance (PSP) Scale Total Score

  Baseline (DB) to 12 Months of DB Phase

• Percentage of Participants With Symptomatic Remission Based on PANSS Score During DB Phase

  Up to 12 months of DB Phase

• Change From Baseline in the Satisfaction With Participants in Social Roles (SPSR) Score

  Baseline (DB) to 12 Months of DB Phase

Study Arms (4)

PP1M: Transition Phase

EXPERIMENTAL

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.

Drug: PP1M

PP1M/PP3M: Maintenance Phase

EXPERIMENTAL

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.

Drug: PP3M 350 mg eq.; Drug: PP3M 525 mg eq.; Drug: PP1M

PP6M or Placebo: Double-Blind Phase

EXPERIMENTAL

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.

Drug: PP6M; Other: Placebo

PP3M: Double-Blind Phase

EXPERIMENTAL

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.

Drug: PP3M 350 mg eq.; Drug: PP3M 525 mg eq.

Interventions

PP6M DRUG

Participants will receive intramuscular injection of PP6M.

Also known as: R092670

PP6M or Placebo: Double-Blind Phase

PP3M 350 mg eq. DRUG

Participants will receive intramuscular injection of PP3M 350 mg eq.

Also known as: R092670

PP1M/PP3M: Maintenance Phase; PP3M: Double-Blind Phase

PP3M 525 mg eq. DRUG

Participants will receive intramuscular injection of PP3M 525 mg eq.

Also known as: R092670

PP1M/PP3M: Maintenance Phase; PP3M: Double-Blind Phase

PP1M DRUG

Participants will receive intramuscular injection of PP1M 50 to 150 mg eq.

Also known as: R092670

PP1M/PP3M: Maintenance Phase; PP1M: Transition Phase

Placebo OTHER

Participants will receive matching placebo.

PP6M or Placebo: Double-Blind Phase

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must meet the diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5) for at least 6 months before screening
• 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

You may not qualify if:

• Must not be receiving any form of involuntary treatment, such as involuntary psychiatric hospitalization, parole-mandated treatment, or court-mandated treatment
• 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 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (138)

Woodland Research Northwest

Rogers, Arkansas, 72758, United States

Location

California Pharmaceutical Research Institute, Inc.

Anaheim, California, 92804, United States

Location

ATP Clinical Research

Costa Mesa, California, 92626, United States

Location

Collaborative NeuroScience Network

Garden Grove, California, 92845, United States

Location

Synergy East

Lemon Grove, California, 91945, United States

Location

Pacific Research Partners

Oakland, California, 94607, United States

Location

SF-Care, Inc

San Rafael, California, 94901, United States

Location

New Life Medical Research Center, Inc.

Hialeah, Florida, 33012, United States

Location

Clintex Research Group

Miami, Florida, 33135, United States

Location

Florida Research Center Inc.

Miami, Florida, 33174, United States

Location

Olympian Clinical Research

Tampa, Florida, 33614, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

Uptown Research Institute

Chicago, Illinois, 60640, United States

Location

Alexian Behavioral Health Hospital

Hoffman Estates, Illinois, 60169, United States

Location

Ascension via Christi Research

Wichita, Kansas, 67214, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Cherry Street Services, Inc.

Grand Rapids, Michigan, 49503, United States

Location

St. Louis Clinical Trials

St Louis, Missouri, 63141, United States

Location

The Zucker Hillside Hospital

Glen Oaks, New York, 11004, United States

Location

Clinical Trials of America Inc

Hickory, North Carolina, 28601, United States

Location

Wexner Medical Center at the Ohio State University

Columbus, Ohio, 43210, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Future Search Trials of Dallas

Dallas, Texas, 75231, United States

Location

Psychiatric and Behavioral Solutions

Salt Lake City, Utah, 84105-2425, United States

Location

Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales

Buenos Aires, C1133AAH, Argentina

Location

CEN

Córdoba, X5004FJF, Argentina

Location

Sanatorio Prof. Leon S. Morra

Córdoba, X5009BIN, Argentina

Location

Instituto de Neurociencias San Agustin

La Plata, 1900, Argentina

Location

Clinica Privada de Salud Mental Santa Teresa de Ávila

La Plata, B1904ADM, Argentina

Location

C I A P Centro de investigacion y Asistencia en Psiquiatria

Rosario, 2000, Argentina

Location

The Lyell McEwin Hospital

Elizabeth Vale, 5112, Australia

Location

Neuro Trials Victoria

Noble Park, 3174, Australia

Location

Trial Tech Tecnologia em Pesquisas com Medicamentos

Curitiba, 80240-280, Brazil

Location

Instituto Bairral de Psiquiatria

Itapira, 13970-905, Brazil

Location

Hospital das Clinicas de Porto Alegre

Porto Alegre, 90035-903, Brazil

Location

Ruschel Medicina e Pesquisa Clínica Ltda

Rio de Janeiro, 22270 060, Brazil

Location

CPQuali Pesquisa Clinica LTDA ME

São Paulo, 01228-900, Brazil

Location

SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo

São Paulo, 04020-060, Brazil

Location

Hospital Das Clinicas Da Faculdade De Medicina Da USP

São Paulo, 05403-903, Brazil

Location

Mental Health Center Prof. Dr. Ivan Temkov

Burgas, 8001, Bulgaria

Location

State Psychiatric Hospital Pazardzhik

Pazardzhik, 4400, Bulgaria

Location

UMHAT 'Sveti Georgi'-Plovdiv

Plovdiv, 4002, Bulgaria

Location

State Psychiatric HospitalDr.Georgi Kissiov

Radnevo, 6260, Bulgaria

Location

Centre for Mental Health Prof.N.Shipkovenski EOOD

Sofia, 1377, Bulgaria

Location

Medical Center Intermedica, OOD

Sofia, 1680, Bulgaria

Location

Psychiatricka ambulance, MUDr. Marta Holanova

Brno, 61500, Czechia

Location

NeuropsychiatrieHK, s.r.o.

Hradec Kralove-Vekose, 50341, Czechia

Location

A Shine S R O

Pilsen, 31200, Czechia

Location

Pragtis S R O

Prague, 12000, Czechia

Location

Institut Neuropsychiatricke pece

Prague, 18600, Czechia

Location

Psychiatricka ambulance MUDr. Simona Papezova

Prague, 19000, Czechia

Location

C.H.S. Charles Perrens

Bordeaux, 33076, France

Location

CHRU La Colombière

Montpellier, 34090, France

Location

CHU Caremeau

Nîmes, 30029, France

Location

Hopital Sainte Anne

Paris, 75674, France

Location

Hopital Sainte Musse

Toulon, 83000, France

Location

Kwai Chung Hospital

Hong Kong, Hong Kong

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Józsefvarosi Szent Kozma Egészségügyi Központ

Budapest, 1084, Hungary

Location

Petz Aladar Megyei Oktato Korhaz

Győr, 9023, Hungary

Location

Bács-Kiskun Megyei Kórház a Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza

Kalocsa, 6300, Hungary

Location

CRU Hungary Kft.

Miskolc, 3529, Hungary

Location

Ratandeep Multispeciality Hospital

Ahmedabad, 380008, India

Location

Sri Ramachandra Medical Centre

Chennai, 600116, India

Location

Asha hospital

Hyderabad, 500034, India

Location

Ahana Hospitals

Madurai, 625020, India

Location

Vinaya Hospital and Research Center

Mangalore, 575003, India

Location

Kasturba Medical College Hospital

Manipal, 576104, India

Location

Jehangir Clinical Development Center Pvt Ltd

Pune, 411001, India

Location

Deva Institute of Health Care and Research Pvt Ltd

Varanasi, 221005, India

Location

Clinica Psichiatrica - Università di Cagliari

Cagliari, 09127, Italy

Location

Dipartimento di Salute Mentale

Lecce, 73100, Italy

Location

Seconda Universita degli Studi di Napoli - Azienda Ospedaliera Universitaria

Napoli, 80138, Italy

Location

Universita degli Studi di Roma 'La Sapienza' - Azienda Ospedaliera Sant Andrea

Roma, 00189, Italy

Location

Hospital Bahagia Ulu Kinta

Ipoh, 31250, Malaysia

Location

Hospital Kuala Lumpur

Kuala Lumpur, 50586, Malaysia

Location

University Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location

Sarawak General Hospital

Kuching, 93586, Malaysia

Location

Gabipros SC

Mexico City, 07810, Mexico

Location

Instituto Neuropsique

Monterrey, 64610, Mexico

Location

Centro de Estudios Clinicos y Especialidades Medicas S C

Monterrey, 64620, Mexico

Location

Infosame/Research

Monterrey, 64710, Mexico

Location

Centro de Atencion e Investigacion Cardiovascular del Potosi S C

San Luis Potosí City, 78200, Mexico

Location

Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk

Bialystok, 15-404, Poland

Location

Wlokiennicza MED Specjalistyczna Praktyka Lekarska dr n.med. Tomasz Markowski

Bialystok, 15-464, Poland

Location

Zespol Opieki Zdrowotnej w Chelmnie

Chełmno, 86-200, Poland

Location

Centrum Badan Klinicznych PI House sp z o o

Gdansk, 80 546, Poland

Location

Szpital Specjalistyczny im H Klimontowicza Oddzial Psychiatryczny

Gorlice, 38-300, Poland

Location

Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS

Leszno, 64-100, Poland

Location

Centrum Medyczne Luxmed Sp z o o

Lublin, 20 109, Poland

Location

Poradnia Zdrowia Psychicznego 'Syntonia' w Pruszczu Gdanskim

Pruszcz Gdański, 83-000, Poland

Location

Mazowieckie Specjalistyczne Centrum Zdrowia im. Prof. Jana Mazurkiewicza w Pruszkowie

Pruszków, 05-802, Poland

Location

Wojewodzki Szpital Zespolony im L Rydygiera w Toruniu

Torun, 87 100, Poland

Location

Clinical Psychiatric Hospital #3 Named After V.A. Gilyarovsky

Moscow, 107076, Russia

Location

Psychiatric Clinical hospital 1 named after N.A. Alekseev

Moscow, 117152, Russia

Location

Nizny Novgorod clinical psychiatric hospital 1

Nizny Novgorod, 603155, Russia

Location

Psychoneurological Dispensary of Frunzensky District

Saint Petersburg, 190013, Russia

Location

Psychoneurological dispensary 10

Saint Petersburg, 190121, Russia

Location

St-Petersburg Bekhterev Psychoneurological Research Institute

Saint Petersburg, 192109, Russia

Location

Psychoneurological dispensary 1

Saint Petersburg, 199178, Russia

Location

SHI 'Saratov City Clinical Hospital 2 n.a V.I. Razumovsky

Saratov, 410028, Russia

Location

Saratov Regional Psychiatric hospital named after St. Sofia

Saratov, 410060, Russia

Location

Psychoneurological Dispensary #4

St.Peterburg, 197110, Russia

Location

Research Institute of Mental Health

Tomsk, 634014, Russia

Location

Sverdlovsk Regional Clinical Psychiatric Hospital

Yekaterinburg, Russia

Location

Flexivest 14 Research

Cape Town, 7550, South Africa

Location

Gert Bosch Pretoria South Africa

Pretoria, 0042, South Africa

Location

Juan Schrönen - Western Cape South Africa

Welgemoed, 7530, South Africa

Location

Chonnam National University Hospital

Gwangju, 61469, South Korea

Location

CHA Bundang Medical Center, CHA University

Gyeonggi-do, 13496, South Korea

Location

Chonbuk National Univ Hospital

Jeonju, 54907, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Hosp Univ Vall D Hebron

Barcelona, 08035, Spain

Location

Inst. Internac. Neurociencias Aplicadas

Barcelona, 8006, Spain

Location

Hosp. Univ. de Basurto

Bilbao, 48013, Spain

Location

Centro Salud Mental La Corredoria

Oviedo, 33011, Spain

Location

Hosp. El Bierzo

Ponferrada, 24404, Spain

Location

Hosp. Clinico Univ. de Valencia

Valencia, 46010, Spain

Location

Hosp. Prov. de Zamora

Zamora, 49021, Spain

Location

National Cheng Kung University Hospital

Tainan, 70403, Taiwan

Location

Mackay Memorial Hospital

Taipei, 10449, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

Abdurrah Yurtarslan Training and Research Hospital

Ankara, 6200, Turkey (Türkiye)

Location

Ankara Numune Research and Training Hospital

Ankara, 6800, Turkey (Türkiye)

Location

Erenkoy Mental Health Hospital

Istanbul, 34736, Turkey (Türkiye)

Location

Selcuk University, Medical School, Department of Psychiatry

Konya, 42130, Turkey (Türkiye)

Location

Sakarya University Medical Faculty Psychiatry Department

Sakarya, 54187, Turkey (Türkiye)

Location

MNCE of Kyiv RC Regional Psychiatric and Narcological Medical Association

Hlevakha, 8630, Ukraine

Location

Mnpe of Kharkiv Regional Council 'Regional Clinical Psychiatric Hospital #3'

Kharkiv, 61068, Ukraine

Location

CNPE'Kherson Regional Institution of Mental Care'of Kherson Regional Council

Kherson, 73488, Ukraine

Location

Kyiv Territorial Medical Incorporation 'Psychiatry'

Kyiv, 04080, Ukraine

Location

Municipal Institution 'Lviv Regional Clinical Psycho-Neurological Dispensary'

Lviv, 79017, Ukraine

Location

CNCE of the Lviv Regional Council 'Lviv Regional Clinical Psychiatric Hospital'

Lviv, 79021, Ukraine

Location

CNCE Odesa regional psychiatric hospital #2 Odesa regional council

Oleksandrivka, 67513, Ukraine

Location

CNCE 'Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council'

Smila, 20708, Ukraine

Location

CNCE 'Vinnytsya RC Psychoneurological Hospital n.a. O.I. Yushchenko Vinnytsya RC'

Vinnytsia, 21005, Ukraine

Location

Related Publications (3)

• 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.

  PMID: 37653768 DERIVED

• 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.

  PMID: 37480362 DERIVED

• 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.

  PMID: 34791283 DERIVED

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Limitations and Caveats

The non-inferiority design was based on the principle of enrichment; that is, criteria of clinical stability were applied prior to entry into the Double-blind Phase. Hence, the ITT (DB) analysis set does not reflect the overall sample of participants who were initially enrolled in Study PSY3015 (ClinicalTrials.gov Identifier: NCT03345342) for treatment with PP3M/PP6M. Therefore, results may not reflect true efficacy for prevention of relapses in the overall population.

Results Point of Contact

• Title: Compound Development Team Leader
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: November 17, 2017
• Study Start: November 20, 2017
• Primary Completion: May 8, 2020
• Study Completion: May 8, 2020
• Last Updated: April 29, 2025
• Results First Posted: December 9, 2021

Record last verified: 2025-04

Locations

AR (6); CZ (6); HU (4); MY (4); IT (4); FR (5); US (25); BR (7); TW (4); AU (2); ZA (3); UA (9); PL (10); TU (5); BU (6); HK (2); RU (12); ME (5); KR (4); ES (7); IN (8)