A Study of Paliperidone Palmitate 6-Month Formulation

Last updated: April 25, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Completed

Phase

3

Condition

Schizotypal Personality Disorder (Spd)

Tourette's Syndrome

Mood Disorders

Treatment

PP6M injection Dose 2

PP6M injection Dose 1

Clinical Study ID

NCT04072575
CR108605
2018-004532-30
R092670PSY3016
  • Ages 18-70
  • All Genders

Study 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

Inclusion Criteria:

  • Completed the Double-blind Phase of Study R092670PSY3015 without relapse andcontinue 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 samedose level (moderate or higher dose) as used during the Double-blind Phase of StudyR092670PSY3015 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 duringthe study and for a minimum 12 months after receiving the last dose of the studyintervention: a) His female partner(s) will use highly effective method pfcontraception

  • Sign an informed consent form (ICF) indicating that he or she understands thepurpose of, and procedures required for, the study and is willing to participate inthe study; and must be able to provide his or her own consent (that is, consentcannot be provided by a legal representative of the participant)

  • In the opinion of the investigator, the patient would be able to participate for theduration of this study

Exclusion

Exclusion Criteria:

  • Has any condition for which, in the opinion of the investigator, participation wouldnot 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 relevantby the investigator, and which may interfere with safety and well-being of theparticipant

  • If a man, has plans to father a child while enrolled in this study or within 12months after the last dose of study intervention. Must not, if a woman, have plansto become pregnant while enrolled in this study or within 12 months after the lastdose of study intervention

Study Design

Total Participants: 178
Treatment Group(s): 2
Primary Treatment: PP6M injection Dose 2
Phase: 3
Study Start date:
September 19, 2019
Estimated Completion Date:
May 03, 2022

Connect with a study center

  • Fundación para el Estudio y Tratamiento de las Enfermedades Mentales

    Ciudad Autonoma de Buenos Aires, C1425AHQ
    Argentina

    Site Not Available

  • Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales

    Ciudad Autónoma De Buenos Aires, C1133AAH
    Argentina

    Site Not Available

  • Fundación para el Estudio y Tratamiento de las Enfermedades Mentales

    Ciudad Autónoma De Buenos Aires, C1133AAH
    Argentina

    Site Not Available

  • CEN Consultorios Especializados en Neurociencias

    Cordoba, X5004FJF
    Argentina

    Site Not Available

  • CEN-Consultorios Especializados en Neurociencias

    Cordoba, X5004FJF
    Argentina

    Site Not Available

  • Sanatorio Prof. Leon S. Morra

    Cordoba, X5009BIN
    Argentina

    Site Not Available

  • Clinica Privada de Salud Mental Santa Teresa de Ávila

    La Plata, B1904ADM
    Argentina

    Site Not Available

  • INSA Instituto de Neurociencias San Agustín

    La Plata, 1900
    Argentina

    Site Not Available

  • C I A P Centro de investigacion y Asistencia en Psiquiatria

    Rosario, 2000
    Argentina

    Site Not Available

  • C.I.A.P. (Centro de investigación y Asistencia en Psiquiatría)

    Rosario, 2000
    Argentina

    Site Not Available

  • Queen Mary Hospital

    Hong Kong,
    Hong Kong

    Site Not Available

  • Dipartimento di Salute Mentale

    Lecce, 73100
    Italy

    Site Not Available

  • Seconda Universita degli Studi di Napoli - Azienda Ospedaliera Universitaria

    Napoli, 80138
    Italy

    Site Not Available

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

    Roma, 00189
    Italy

    Site Not Available

  • Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk

    Bialystok, 15-404
    Poland

    Site Not Available

  • Zespol Opieki Zdrowotnej w Chelmnie

    Chelmno, 86-200
    Poland

    Site Not Available

  • Centrum Badan Klinicznych PI House sp z o o

    Gdansk, 80 546
    Poland

    Site Not Available

  • Centrum Badań Klinicznych PI-House sp. z o.o.

    Gdansk, 80-546
    Poland

    Site Not Available

  • Centrum Badań Klinicznych PI-House sp. z o.o.

    Gdańsk, 80-546
    Poland

    Site Not Available

  • Specjalistyczna Praktyka Lekarska Piotr Zalitacz

    Gorlice, 38-300
    Poland

    Site Not Available

  • Specjalistyczna Praktyka Lekarska lek. Piotr Zalitacz

    Gorlice, 38-300
    Poland

    Site Not Available

  • Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS

    Leszno, 64-100
    Poland

    Site Not Available

  • Centrum Medyczne Luxmed Sp z o o

    Lublin, 20 109
    Poland

    Site Not Available

  • Poradnia Zdrowia Psychicznego 'Syntonia' w Pruszczu Gdanskim

    Pruszcz Gdanski, 83-000
    Poland

    Site Not Available

  • Sverdlovsk Regional Clinical Psychiatric Hospital

    Ekaterinburg,
    Russian Federation

    Site Not Available

  • Nizny Novgorod clinical psychiatric hospital 1

    Nizny Novgorod, 603155
    Russian Federation

    Site Not Available

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

    Saratov, 410028
    Russian Federation

    Site Not Available

  • Saratov Regional Psychiatric hospital named after St. Sofia

    Saratov, 410060
    Russian Federation

    Site Not Available

  • Research Institute of Mental Health

    Tomsk, 634014
    Russian Federation

    Site Not Available

  • MNCE of Kyiv RC Regional Psychiatric and Narcological Medical Association

    Glevakha, 8630
    Ukraine

    Site Not Available

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

    Kharkiv, 61068
    Ukraine

    Site Not Available

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

    Kherson, 73488
    Ukraine

    Site Not Available

  • Kyiv Territorial Medical Incorporation 'Psychiatry'

    Kyiv, 04080
    Ukraine

    Site Not Available

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

    Lviv, 79021
    Ukraine

    Site Not Available

  • Mnpe of Lviv Regional Council 'Lviv Regional Clinical Psycho-Neurological Dispensary'

    Lviv, 79000
    Ukraine

    Site Not Available

  • CNCE Odesa regional psychiatric hospital #2 Odesa regional council

    Oleksandrivka, 67513
    Ukraine

    Site Not Available

  • CNCE'Odesa regional psychiatric hospital #2" Odesa regional council'

    Oleksandrivka, Kominternivskyi District, 67513
    Ukraine

    Site Not Available

  • CNCE 'Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council'

    Smila, 20708
    Ukraine

    Site Not Available

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

    Vinnytsia, 21005
    Ukraine

    Site Not Available

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