An Efficacy and Safety Study of Extended-Release (ER) Paliperidone in Adolescent Participants With Schizophrenia

Last updated: June 20, 2013
Sponsor: Janssen Research & Development, LLC
Overall Status: Completed

Phase

3

Condition

Tourette's Syndrome

Schizotypal Personality Disorder (Spd)

Psychosis

Treatment

N/A

Clinical Study ID

NCT01009047
CR016675
R076477PSZ3003
  • Ages 12-17
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy and safety of extended-release (ER) paliperidone compared to aripiprazole (atypical antipsychotic) in symptomatic (having symptoms) adolescent participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations [imagining things], and withdrawal into the self) .

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants must currently meet the Diagnostic and Statistical Manual of MentalDisorders Fourth Edition (DSM-IV) criteria for schizophrenia and have experiencedsymptoms of the illness for at least 1 year, and they should have had at leasttreatment with 1 antipsychotic before participation in this study

  • Participants having a Positive and Negative Syndromes Scale (PANSS) score between 60and 120 inclusive at Screening

  • Female participants must be incapable of pregnancy, or if heterosexually active andcapable of pregnancy, have been using an acceptable method of contraception for atleast 1 month before study entry and agree to continue use contraception methods forthe duration of the study, or if sexually abstinent (not having sexual intercourse)and capable of pregnancy, must agree to continue abstinence or to use an acceptablemethod of birth control

  • Participants must not be a danger to themselves or others, and must have familysupport available to be maintained as out-patients

  • Participants with a weight of equal to or greater than 29 kilogram

Exclusion

Exclusion Criteria:

  • Participants with mild (not serious), moderate (medium level of seriousness), orsevere (very serious, life threatening) mental retardation

  • Participants with a known or suspected history of substance dependence (includingalcohol, but excluding nicotine or caffeine) as per the DSM-IV criteria in the 3months before Screening

  • Participants with a history of certain neurological (pertaining to the nervous system)disorders or insulin-dependent diabetes mellitus (disorder in which there is decreasedinsulin in the body or the body's insulin is not effective, resulting in high bloodsugar, increased thirst and urine, and many other side effects)

  • Participants who have received a depot injectable antipsychotic within 2 treatmentcycles before the Screening visit

  • Participants who have received clozapine in 2 months before the Baseline visit (Day 1of Week 1)

Study Design

Total Participants: 228
Study Start date:
December 01, 2009
Estimated Completion Date:
June 30, 2012

Study Description

This is a multi-center (conducted in more than 1 center), double-blind (neither physician nor participant knows the name of the assigned drug), randomized (study drug is assigned by chance), active-controlled (paliperidone ER is compared to aripiprazole), parallel-group (a medical research study comparing the response in 2 or more groups of participants receiving different treatments), flexible-dose (the physician has the freedom to give different doses to the participant depending on how they respond to treatment) study designed to determine the efficacy and safety of paliperidone ER in symptomatic adolescents (12 to 17 years of age) with schizophrenia. The total duration of the study will be approximately 29 weeks. The study consists of 3 phases: a Screening phase up to 3 weeks (with a possible overlapping washout period), a Double-blind acute phase of 8 weeks, and a Double-blind maintenance phase of 18 weeks. Participants will be randomly assigned to 1 of the 2 treatment groups (paliperidone ER or aripiprazole flexible oral doses). Dosage will be adjusted at the scheduled visits. Efficacy of the participants will primarily be evaluated through Positive and Negative Syndromes Scale (PANSS). Participants' safety will be monitored throughout the study.

Connect with a study center

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    Brno,
    Czech Republic

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    Praha 10,
    Czech Republic

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    Praha 5 N/A,
    Czech Republic

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    Calicut,
    India

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  • Jaipur,
    India

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  • Kanpur Uttarpradeh,
    India

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  • Lucknow Gpo,
    India

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  • Mangalore,
    India

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  • Varanasi,
    India

    Site Not Available

  • Bucharest,
    Romania

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  • Chelyabinsk,
    Russian Federation

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    Ekaterinburg,
    Russian Federation

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  • Ekaterinburg Na,
    Russian Federation

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    Kemerovo,
    Russian Federation

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  • Krasnodar N/A,
    Russian Federation

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    Moscow,
    Russian Federation

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  • Moscow N/A,
    Russian Federation

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  • Moscow Russia,
    Russian Federation

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  • Nizhniy Novgorod,
    Russian Federation

    Site Not Available

  • Novosibirsk,
    Russian Federation

    Site Not Available

  • Saint Petersburg,
    Russian Federation

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  • Samara,
    Russian Federation

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  • Saratov,
    Russian Federation

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  • Smolensk Region N/A,
    Russian Federation

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  • St Petersburg,
    Russian Federation

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  • St-Petersburg,
    Russian Federation

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  • Tomsk Na,
    Russian Federation

    Site Not Available

  • Yaroslavl N/A,
    Russian Federation

    Site Not Available

  • Bratislava,
    Slovakia

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    Kosice,
    Slovakia

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    Martin,
    Slovakia

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  • Badajoz,
    Spain

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  • Esplugues De Llobregat,
    Spain

    Site Not Available

  • Madrid,
    Spain

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  • Paterna,
    Spain

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  • Sabadell,
    Spain

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  • Sevilla,
    Spain

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  • Valladolid,
    Spain

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    Zaragoza,
    Spain

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    Dnepropetrovsk,
    Ukraine

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  • Donetsk,
    Ukraine

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  • Glevakha,
    Ukraine

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  • Ivano-Frankivsk,
    Ukraine

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  • Ivano-Frankovsk,
    Ukraine

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  • Kharkiv,
    Ukraine

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  • Kherson,
    Ukraine

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  • Kiev,
    Ukraine

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    Odessa,
    Ukraine

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  • Poltava,
    Ukraine

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  • Simferopol,
    Ukraine

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    Vinnitsa,
    Ukraine

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  • Dothan, Alabama
    United States

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  • Santa Ana, California
    United States

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    Washington, District of Columbia
    United States

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  • Atlanta, Georgia
    United States

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  • Smyrna, Georgia
    United States

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    Hoffman Estates, Illinois
    United States

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  • Lake Charles, Louisiana
    United States

    Site Not Available

  • Shreveport, Louisiana
    United States

    Site Not Available

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    Portsmount, Virginia
    United States

    Site Not Available

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