Clinical trial NCT04072575: A Study of Paliperidone Palmitate 6-Month Formulation
Official title: Single-arm, Open-label Extension to 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: 2019-08-28
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to assess the long-term safety and tolerability of paliperidone 6-month PP6M (Dose 1 or Dose 2 \[milligram\] mg eq.) and to provide access to PP6M in participants with schizophrenia completing the R092670PSY3015 study without relapse.


Eligibility criteria: Inclusion Criteria:

* Completed the Double-blind Phase of Study R092670PSY3015 without relapse and continue to be willing to be treated with paliperidone palmitate 6 month injection (PP6M)
* Must, in the opinion of the investigator, be able to continue treatment at the same dose level (moderate or higher dose) as used during the Double-blind Phase of Study R092670PSY3015 at the time of screening for this study
* A woman of childbearing potential: a) Must have a negative pregnancy test on Day 1; b) Use contraception consistent with local regulations. A man must agree that during the study and for a minimum 12 months after receiving the last dose of the study intervention: a) His female partner(s) will use highly effective method pf contraception
* Sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study; and must be able to provide his or her own consent (that is, consent cannot be provided by a legal representative of the participant)
* In the opinion of the investigator, the patient would be able to participate for the duration of this study

Exclusion Criteria:

* Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
* Completed R092670PSY3015 while presenting adverse events deemed clinically relevant by the investigator, and which may interfere with safety and well-being of the participant
* If a man, has plans to father a child while enrolled in this study or within 12 months after the last dose of study intervention. Must not, if a woman, have plans to become pregnant while enrolled in this study or within 12 months after the last dose of study intervention

Primary outcomes:
measure: Number of Participants With Relapse
timeFrame: Up to Day 730
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to Day 730
Secondary outcomes:
measure: Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score
timeFrame: Baseline up to Day 730
measure: Change From Baseline in Personal and Social Performance (PSP) Scale Score
timeFrame: Baseline up to Day 730
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
timeFrame: Baseline up to Day 730
Other outcomes:
Locations:
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 Consultorios Especializados en Neurociencias
city: Cordoba
country: Argentina
facility: Sanatorio Prof. Leon S. Morra
city: La Plata
country: Argentina
facility: INSA Instituto de Neurociencias San Agustín
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: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
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: Bialystok
country: Poland
facility: Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk
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: Specjalistyczna Praktyka Lekarska Piotr Zalitacz
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: Ekaterinburg
country: Russian Federation
facility: Sverdlovsk Regional Clinical Psychiatric Hospital
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: Tomsk
country: Russian Federation
facility: Research Institute of Mental Health
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: Lviv
country: Ukraine
facility: Mnpe of Lviv Regional Council '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: