A Study of Transition to the Paliperidone Palmitate 3-Month Formulation In Participants With Schizophrenia Previously Stabilized on the Paliperidone Palmitate 1-Month Formulation

Last updated: May 11, 2016
Sponsor: Janssen-Cilag Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Tourette's Syndrome

Schizotypal Personality Disorder (Spd)

Mood Disorders

Treatment

N/A

Clinical Study ID

NCT02772393
CR108121
2015-004835-10
R092670SCH3015
  • Ages 18-50
  • Both

Study Summary

The purpose of this study is to estimate the proportion of participants fulfilling criteria for symptomatic remission following a transition to 12 months treatment with flexible-dose paliperidone palmitate 3 month formulation (PP3M) in participants with schizophrenia previously adequately treated with paliperidone palmitate 1 month formulation (PP1M) for at least 4 months.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Meets Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5)criteria for a diagnosis of schizophrenia

  • Able to read, understand, and sign the informed consent form (ICF) indicating that heor she understands the purpose of and procedures required for the study and arewilling to participate in the study

  • Willing and able to fill out self-administered questionnaires

  • Willing and able to adhere to the prohibitions and restrictions specified in theprotocol

  • A woman of childbearing potential must have a negative urine pregnancy test atScreening and baseline

  • A woman must agree not to donate eggs (ova, oocytes) for the purposes of assistedreproduction during the study and for 6 months after receiving the last dose of studydrug

Exclusion

Exclusion Criteria:

  • His/her psychiatric diagnosis is due to direct pharmacological effects of a substance (example, a drug of abuse or medication) or a general medical condition (example,clinically notable hypothyroidism, organic brain disorder)

  • Experienced intolerable side effects during treatment with paliperidone palmitate 1-month formulation (PP1M)

  • Has a known hypersensitivity to paliperidone or risperidone

  • Has received any other long-acting injectable antipsychotic medication other thanPP1M within the last 4 months before the first injection of the study drugpaliperidone palmitate 3-month formulation (PP3M)

  • Has received clozapine during the last 3 months before the Screening visit

  • Is considered to be at imminent risk of suicide, even after clinical intervention

  • Has a serious unstable medical condition, including recent and present clinicallyrelevant laboratory abnormalities

  • Has a history or current symptoms of tardive dyskinesia or neuroleptic malignantsyndrome

  • Is a woman who is pregnant or breast-feeding, or planning to become pregnant whileenrolled in this study or within 6 months after the last dose of PP3M

  • Has participated in an investigational drug trial in the 30 days prior to theScreening visit or is currently enrolled in an investigational study

  • Has a current DSM-5 diagnosis of dissociative disorder, bipolar disorder, majordepressive disorder, schizoaffective disorder, autistic disorder, or intellectualdisabilities and/or meets the DSM-5 definition of severe substance use disorder (except for nicotine and caffeine) within 6 months prior to screening; however,participants with mild or moderate substance use disorder, with the exception ofintravenous drug use, will be eligible for enrollment

Study Design

Total Participants: 300
Study Start date:
April 01, 2016
Estimated Completion Date:
March 31, 2018

Study Description

This is an international, multicenter (study conducted at multiple sites) study designed to estimate remission rates and assess treatment response, tolerability, and patterns of use of Paliperidone Palmitate 3-Month Formulation (PP3M) in a diverse population of participants with schizophrenia. The study will consist of a screening phase (Day -7 to Day 1), a 52-week, open-label, flexible-dose PP3M treatment phase and a follow up safety assessment 3 months (+/-14 days) after the month 12 visit or early discontinuation. Participants' Safety will be monitored throughout the study.

Connect with a study center

  • Rijeka,
    Croatia

    Site Not Available

  • Split,
    Croatia

    Site Not Available

  • Zagreb,
    Croatia

    Site Not Available

  • Esbjerg,
    Denmark

    Site Not Available

  • Middelfart,
    Denmark

    Site Not Available

  • Clermont Ferrand,
    France

    Site Not Available

  • Montpellier,
    France

    Site Not Available

  • Paris,
    France

    Site Not Available

  • Rennes,
    France

    Site Not Available

  • Toulon,
    France

    Site Not Available

  • Berlin,
    Germany

    Site Not Available

  • Hamburg,
    Germany

    Site Not Available

  • Stralsund,
    Germany

    Site Not Available

  • Beer Yaakov,
    Israel

    Site Not Available

  • Emek Hefer,
    Israel

    Site Not Available

  • Ness Ziona,
    Israel

    Site Not Available

  • Petach Tikva,
    Israel

    Site Not Available

  • Ramat Gan,
    Israel

    Site Not Available

  • Gwangju,
    Korea, Republic of

    Site Not Available

  • Jeonju,
    Korea, Republic of

    Site Not Available

  • Seongnam,
    Korea, Republic of

    Site Not Available

  • Seoul,
    Korea, Republic of

    Site Not Available

  • Ipoh,
    Malaysia

    Site Not Available

  • Johor Bahru,
    Malaysia

    Site Not Available

  • Kuala Lumpur,
    Malaysia

    Site Not Available

  • Assen,
    Netherlands

    Site Not Available

  • Groningen,
    Netherlands

    Site Not Available

  • Moscow,
    Russian Federation

    Site Not Available

  • St-Petersburg,
    Russian Federation

    Site Not Available

  • Barcelona,
    Spain

    Site Not Available

  • Bilbao,
    Spain

    Site Not Available

  • Burgos,
    Spain

    Site Not Available

  • Madrid,
    Spain

    Active - Recruiting

  • Oviedo,
    Spain

    Site Not Available

  • Sabadell,
    Spain

    Site Not Available

  • Valencia,
    Spain

    Active - Recruiting

  • New Taipei City,
    Taiwan

    Site Not Available

  • Tainan,
    Taiwan

    Site Not Available

  • Taoyuan,
    Taiwan

    Site Not Available

  • Ankara,
    Turkey

    Site Not Available

  • Bursa,
    Turkey

    Site Not Available

  • Istanbul,
    Turkey

    Site Not Available

  • Sakarya,
    Turkey

    Site Not Available

  • Derby,
    United Kingdom

    Site Not Available

  • Edinburgh,
    United Kingdom

    Site Not Available

  • Reading,
    United Kingdom

    Site Not Available

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