Clinical trial NCT03345342: A Study of Paliperidone Palmitate 6-Month Formulation
Official title: A Double-blind, Randomized, Active-controlled, Parallel-group Study of Paliperidone Palmitate 6-Month Formulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2017-11-17
Enrollment: 841
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.).

Detailed description: The primary hypothesis of this study is that the efficacy of PP6M is non-inferior to PP3M for preventing relapse in participants with schizophrenia who were previously stabilized on corresponding doses of PP1M or PP3M. The study consists of mainly 3 phases: a screening phase (up to 28 days), a maintenance phase (of 1 or 3 months), and a double-blind phase (of 12 months \[neither the researchers nor the participants know what treatment the participant is receiving\]). Additional/conditional phases include a transition phase (before maintenance phase). Study evaluations include efficacy, pharmacokinetics, pharmacodynamics, and safety. The study duration will vary from approximately 13 months to 19 months.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria

* 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 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

Primary outcomes:
measure: Time to Relapse During the Double-Blind (DB) Phase
timeFrame: Up to 12 months of DB Phase
Secondary outcomes:
measure: Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score
timeFrame: Baseline (DB) to 12 Months of DB Phase
measure: Change From Baseline in the Clinical Global Impression - Severity (CGI-S) Score
timeFrame: Baseline (DB) to 12 Months of DB Phase
measure: Change From Baseline in the Personal and Social Performance (PSP) Scale Total Score
timeFrame: Baseline (DB) to 12 Months of DB Phase
measure: Percentage of Participants With Symptomatic Remission Based on PANSS Score During DB Phase
timeFrame: Up to 12 months of DB Phase
measure: Change From Baseline in the Satisfaction With Participants in Social Roles (SPSR) Score
timeFrame: Baseline (DB) to 12 Months of DB Phase
measure: Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM-9) Total Score
timeFrame: Baseline (DB) to 12 Months of DB Phase
measure: Change From Baseline in the Simpson-Angus Rating Scale (SAS) Total Score
timeFrame: Baseline (DB) to 12 Months of DB Phase
measure: Number of Participants With Symptoms of Akathisia Assessed Using Barnes Akathisia Rating Scale (BARS) Score
timeFrame: Up to 12 Months of DB Phase
measure: Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) Total Score
timeFrame: Baseline (DB) to 12 Months of DB Phase
measure: Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score
timeFrame: Baseline and endpoint (12 Months of DB Phase)
measure: Number of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Values During DB Phase
timeFrame: Baseline (DB) to 12 Months of DB Phase
measure: Change From Baseline in the Body Mass Index (BMI) During DB Phase
timeFrame: Baseline (DB) to 12 Months of DB Phase
measure: Change From Baseline in the Waist Circumference During DB Phase
timeFrame: Baseline (DB) to 12 Months of DB Phase
measure: Change From Baseline in the Body Weight During DB Phase
timeFrame: Baseline (DB) to 12 Months of DB Phase
measure: Change From Baseline in the Vital Signs (Pulse Rate) During DB Phase
timeFrame: Baseline (DB) to 12 Months of DB Phase
measure: Change From Baseline in the Vital Signs (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP]) During DB Phase
timeFrame: Baseline (DB) to 12 Months of DB Phase
measure: Change From Baseline in Positive and Syndrome Scale (PANSS) Subscales Score During DB Phase
timeFrame: Baseline (DB) to 12 Months of DB Phase
measure: Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase
timeFrame: Up to 12 Months of DB Phase
measure: Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase
timeFrame: Up to 12 Months of DB Phase
Other outcomes:
Locations:
city: Rogers
country: United States
facility: Woodland Research Northwest
state: Arkansas
city: Anaheim
country: United States
facility: California Pharmaceutical Research Institute, Inc.
state: California
city: Costa Mesa
country: United States
facility: ATP Clinical Research
state: California
city: Garden Grove
country: United States
facility: Collaborative NeuroScience Network
state: California
city: Lemon Grove
country: United States
facility: Synergy East
state: California
city: Oakland
country: United States
facility: Pacific Research Partners
state: California
city: San Rafael
country: United States
facility: SF-Care, Inc
state: California
city: Hialeah
country: United States
facility: New Life Medical Research Center, Inc.
state: Florida
city: Miami
country: United States
facility: Clintex Research Group
state: Florida
city: Miami
country: United States
facility: Florida Research Center Inc.
state: Florida
city: Tampa
country: United States
facility: Olympian Clinical Research
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Chicago
country: United States
facility: Uptown Research Institute
state: Illinois
city: Hoffman Estates
country: United States
facility: Alexian Behavioral Health Hospital
state: Illinois
city: Wichita
country: United States
facility: Ascension via Christi Research
state: Kansas
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Grand Rapids
country: United States
facility: Cherry Street Services, Inc.
state: Michigan
city: Saint Louis
country: United States
facility: St. Louis Clinical Trials
state: Missouri
city: Glen Oaks
country: United States
facility: The Zucker Hillside Hospital
state: New York
city: Hickory
country: United States
facility: Clinical Trials of America Inc
state: North Carolina
city: Columbus
country: United States
facility: Wexner Medical Center at the Ohio State University
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania Medical Center
state: Pennsylvania
city: Dallas
country: United States
facility: Future Search Trials of Dallas
state: Texas
city: Salt Lake City
country: United States
facility: Psychiatric and Behavioral Solutions
state: Utah
city: Ciudad Autónoma De Buenos Aires
country: Argentina
facility: Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales
city: Cordoba
country: Argentina
facility: CEN
city: Cordoba
country: Argentina
facility: Sanatorio Prof. Leon S. Morra
city: La Plata
country: Argentina
facility: Instituto de Neurociencias San Agustin
city: La Plata
country: Argentina
facility: Clinica Privada de Salud Mental Santa Teresa de Ávila
city: Rosario
country: Argentina
facility: C I A P Centro de investigacion y Asistencia en Psiquiatria
city: Elizabeth Vale
country: Australia
facility: The Lyell McEwin Hospital
city: Noble Park
country: Australia
facility: Neuro Trials Victoria
city: Curitiba
country: Brazil
facility: Trial Tech Tecnologia em Pesquisas com Medicamentos
city: Itapira
country: Brazil
facility: Instituto Bairral de Psiquiatria
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas de Porto Alegre
city: Rio de Janeiro
country: Brazil
facility: Ruschel Medicina e Pesquisa Clínica Ltda
city: Sao Paulo
country: Brazil
facility: SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo
city: São Paulo
country: Brazil
facility: CPQuali Pesquisa Clinica LTDA ME
city: São Paulo
country: Brazil
facility: Hospital Das Clinicas Da Faculdade De Medicina Da USP
city: Bourgas
country: Bulgaria
facility: Mental Health Center Prof. Dr. Ivan Temkov
city: Pazardzhik
country: Bulgaria
facility: State Psychiatric Hospital Pazardzhik
city: Plovdiv
country: Bulgaria
facility: UMHAT 'Sveti Georgi'-Plovdiv
city: Radnevo
country: Bulgaria
facility: State Psychiatric HospitalDr.Georgi Kissiov
city: Sofia
country: Bulgaria
facility: Centre for Mental Health Prof.N.Shipkovenski EOOD
city: Sofia
country: Bulgaria
facility: Medical Center Intermedica, OOD
city: Brno
country: Czechia
facility: Psychiatricka ambulance, MUDr. Marta Holanova
city: Hradec Kralove-Vekose
country: Czechia
facility: NeuropsychiatrieHK, s.r.o.
city: Plzen
country: Czechia
facility: A Shine S R O
city: Prague
country: Czechia
facility: Institut Neuropsychiatricke pece
city: Prague
country: Czechia
facility: Psychiatricka ambulance MUDr. Simona Papezova
city: Praha 2
country: Czechia
facility: Pragtis S R O
city: Bordeaux
country: France
facility: C.H.S. Charles Perrens
city: Montpellier
country: France
facility: CHRU La Colombière
city: Nimes Cedex 9
country: France
facility: CHU Caremeau
city: Paris
country: France
facility: Hopital Sainte Anne
city: Toulon Cedex
country: France
facility: Hopital Sainte Musse
city: Hong Kong
country: Hong Kong
facility: Kwai Chung Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Budapest
country: Hungary
facility: Józsefvarosi Szent Kozma Egészségügyi Központ
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz
city: Kalocsa
country: Hungary
facility: Bács-Kiskun Megyei Kórház a Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza
city: Miskolc
country: Hungary
facility: CRU Hungary Kft.
city: Ahmedabad
country: India
facility: Ratandeep Multispeciality Hospital
city: Chennai
country: India
facility: Sri Ramachandra Medical Centre
city: Hyderabad
country: India
facility: Asha hospital
city: Madurai
country: India
facility: Ahana Hospitals
city: Mangalore
country: India
facility: Vinaya Hospital and Research Center
city: Manipal
country: India
facility: Kasturba Medical College Hospital
city: Pune
country: India
facility: Jehangir Clinical Development Center Pvt Ltd
city: Varanasi
country: India
facility: Deva Institute of Health Care and Research Pvt Ltd
city: Cagliari
country: Italy
facility: Clinica Psichiatrica - Università di Cagliari
city: Lecce
country: Italy
facility: Dipartimento di Salute Mentale
city: Napoli
country: Italy
facility: Seconda Universita degli Studi di Napoli - Azienda Ospedaliera Universitaria
city: Roma
country: Italy
facility: Universita degli Studi di Roma 'La Sapienza' - Azienda Ospedaliera Sant Andrea
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National Univ Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Ipoh
country: Malaysia
facility: Hospital Bahagia Ulu Kinta
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Kuching
country: Malaysia
facility: Sarawak General Hospital
city: Mexico City
country: Mexico
facility: Gabipros SC
city: Monterrey
country: Mexico
facility: Instituto Neuropsique
city: Monterrey
country: Mexico
facility: Centro de Estudios Clinicos y Especialidades Medicas S C
city: Monterrey
country: Mexico
facility: Infosame/Research
city: San Luis Potosí
country: Mexico
facility: Centro de Atencion e Investigacion Cardiovascular del Potosi S C
city: Bialystok
country: Poland
facility: Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk
city: Bialystok
country: Poland
facility: Wlokiennicza MED Specjalistyczna Praktyka Lekarska dr n.med. Tomasz Markowski
city: Chelmno
country: Poland
facility: Zespol Opieki Zdrowotnej w Chelmnie
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI House sp z o o
city: Gorlice
country: Poland
facility: Szpital Specjalistyczny im H Klimontowicza Oddzial Psychiatryczny
city: Leszno
country: Poland
facility: Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
city: Lublin
country: Poland
facility: Centrum Medyczne Luxmed Sp z o o
city: Pruszcz Gdanski
country: Poland
facility: Poradnia Zdrowia Psychicznego 'Syntonia' w Pruszczu Gdanskim
city: Pruszkow
country: Poland
facility: Mazowieckie Specjalistyczne Centrum Zdrowia im. Prof. Jana Mazurkiewicza w Pruszkowie
city: Torun
country: Poland
facility: Wojewodzki Szpital Zespolony im L Rydygiera w Toruniu
city: Ekaterinburg
country: Russian Federation
facility: Sverdlovsk Regional Clinical Psychiatric Hospital
city: Moscow
country: Russian Federation
facility: Clinical Psychiatric Hospital #3 Named After V.A. Gilyarovsky
city: Moscow
country: Russian Federation
facility: Psychiatric Clinical hospital 1 named after N.A. Alekseev
city: Nizny Novgorod
country: Russian Federation
facility: Nizny Novgorod clinical psychiatric hospital 1
city: Saratov
country: Russian Federation
facility: SHI 'Saratov City Clinical Hospital 2 n.a V.I. Razumovsky
city: Saratov
country: Russian Federation
facility: Saratov Regional Psychiatric hospital named after St. Sofia
city: St-Petersburg
country: Russian Federation
facility: Psychoneurological Dispensary of Frunzensky District
city: St-Petersburg
country: Russian Federation
facility: Psychoneurological dispensary 10
city: St-Petersburg
country: Russian Federation
facility: St-Petersburg Bekhterev Psychoneurological Research Institute
city: St-Petersburg
country: Russian Federation
facility: Psychoneurological dispensary 1
city: St.Peterburg
country: Russian Federation
facility: Psychoneurological Dispensary #4
city: Tomsk
country: Russian Federation
facility: Research Institute of Mental Health
city: Cape Town
country: South Africa
facility: Flexivest 14 Research
city: Pretoria
country: South Africa
facility: Gert Bosch Pretoria South Africa
city: Welgemoed
country: South Africa
facility: Juan Schrönen - Western Cape South Africa
city: Barcelona
country: Spain
facility: Hosp Univ Vall D Hebron
city: Barcelona
country: Spain
facility: Inst. Internac. Neurociencias Aplicadas
city: Bilbao
country: Spain
facility: Hosp. Univ. de Basurto
city: Oviedo
country: Spain
facility: Centro Salud Mental La Corredoria
city: Ponferrada
country: Spain
facility: Hosp. El Bierzo
city: Valencia
country: Spain
facility: Hosp. Clinico Univ. de Valencia
city: Zamora
country: Spain
facility: Hosp. Prov. de Zamora
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
city: Ankara
country: Turkey
facility: Abdurrah Yurtarslan Training and Research Hospital
city: Ankara
country: Turkey
facility: Ankara Numune Research and Training Hospital
city: Istanbul
country: Turkey
facility: Erenkoy Mental Health Hospital
city: Konya
country: Turkey
facility: Selcuk University, Medical School, Department of Psychiatry
city: Sakarya
country: Turkey
facility: Sakarya University Medical Faculty Psychiatry Department
city: Glevakha
country: Ukraine
facility: MNCE of Kyiv RC Regional Psychiatric and Narcological Medical Association
city: Kharkiv
country: Ukraine
facility: Mnpe of Kharkiv Regional Council 'Regional Clinical Psychiatric Hospital #3'
city: Kherson
country: Ukraine
facility: CNPE'Kherson Regional Institution of Mental Care'of Kherson Regional Council
city: Kyiv
country: Ukraine
facility: Kyiv Territorial Medical Incorporation 'Psychiatry'
city: Lviv
country: Ukraine
facility: Municipal Institution 'Lviv Regional Clinical Psycho-Neurological Dispensary'
city: Lviv
country: Ukraine
facility: CNCE of the Lviv Regional Council 'Lviv Regional Clinical Psychiatric Hospital'
city: Oleksandrivka
country: Ukraine
facility: CNCE Odesa regional psychiatric hospital #2 Odesa regional council
city: Smila
country: Ukraine
facility: CNCE 'Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council'
city: Vinnytsia
country: Ukraine
facility: CNCE 'Vinnytsya RC Psychoneurological Hospital n.a. O.I. Yushchenko Vinnytsya RC'
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.