An Efficacy and Safety Study of Extended-Release (ER) Paliperidone in Adolescent Participants With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Paliperidone extended release (ER); Aripiprazole
Intervention description: Paliperidone ER will be administered as oral capsule at a dose of 6 mg for 1 week and then will be administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.; Aripiprazole will be administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4, 10 mg Days 5, 6 and 7; and then will be administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
Intervention MeSH terms: Aripiprazole; Paliperidone Palmitate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 228.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Schizophrenia; Paliperidone; Aripiprazole

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 Criteria:

          -  Participants must currently meet the Diagnostic and Statistical Manual of Mental
             Disorders Fourth Edition (DSM-IV) criteria for schizophrenia and have experienced
             symptoms of the illness for at least 1 year, and they should have had at least
             treatment with 1 antipsychotic before participation in this study

          -  Participants having a Positive and Negative Syndromes Scale (PANSS) score between 60
             and 120 inclusive at Screening

          -  Female participants must be incapable of pregnancy, or if heterosexually active and
             capable of pregnancy, have been using an acceptable method of contraception for at
             least 1 month before study entry and agree to continue use contraception methods for
             the 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 acceptable
             method of birth control

          -  Participants must not be a danger to themselves or others, and must have family
             support available to be maintained as out-patients

          -  Participants with a weight of equal to or greater than 29 kilogram

        Exclusion Criteria:

          -  Participants with mild (not serious), moderate (medium level of seriousness), or
             severe (very serious, life threatening) mental retardation

          -  Participants with a known or suspected history of substance dependence (including
             alcohol, but excluding nicotine or caffeine) as per the DSM-IV criteria in the 3
             months 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 decreased
             insulin in the body or the body's insulin is not effective, resulting in high blood
             sugar, increased thirst and urine, and many other side effects)

          -  Participants who have received a depot injectable antipsychotic within 2 treatment
             cycles before the Screening visit

          -  Participants who have received clozapine in 2 months before the Baseline visit (Day 1
             of Week 1)