A Double-blind, Placebo-controlled Study of the Safety and Efficacy of Paliperidone Extended Release (ER) in the Treatment of Schizophrenia in Adolescent Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Paliperidone ER; Placebo; Paliperidone ER; Paliperidone ER
Intervention description: 3 mg or 6 mg tablet once daily for 6 weeks; Once daily for 6 weeks; 1.5 mg tablet once daily for 6 weeks; 6 mg or 12 mg tablet once daily for 6 weeks
Intervention MeSH terms: Paliperidone Palmitate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 201.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Schizophrenia; Antipsychotic

Summary:

      The purpose of this study is to evaluate the efficacy, safety, and tolerability of 3
      weight-based, fixed-dose groups of paliperidone extended release (ER) compared with placebo
      in adolescent patients between 12 to 17 years of age, who are diagnosed with schizophrenia.
      Paliperidone ER is an atypical antipsychotic agent approved by the U.S. Food and Drug
      Administration for the treatment of schizophrenia in adults. Patients may be voluntary
      inpatients or outpatients at the time of the screening visit, but should have returned to
      their usual living situation by Day 21 of the double-blind treatment phase. The study
      duration is approximately 10 weeks. Patients who have completed this study or who were
      discontinued from this study due to lack of efficacy but have completed at least 21 days of
      double-blind treatment and are expected to benefit from paliperidone treatment, may enter an
      optional open-label safety study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must meet the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM
             IV) criteria for schizophrenia (295.10, 295.20, 295.30, 295.60, 295.90) for 1 year
             (the diagnosis will be established using the K-SADS-PL, including all supplements)

          -  Must not be a danger to themselves or others, and must have family support available
             to be maintained as an outpatient

          -  Should have had at least 1 adequate treatment with an antipsychotic before
             participation in this study

          -  Must have a PANSS score between 60 and 120, inclusive, at screening and baseline

          -  Weight >=29 kg

        Exclusion Criteria:

          -  Meet the DSM-IV criteria at screening for dissociative disorder, bipolar disorder,
             major depressive disorder, schizoaffective disorder, schizophreniform disorder,
             autistic disorder, or primary substance induced psychotic disorder. Other comorbid
             disorders e.g., attention-deficit hyperactivity disorder (ADHD) are allowed as long as
             the diagnosis of schizophrenia is the primary diagnosis and the comorbid disorders in
             the investigator's judgment do not require medication

          -  Mild, moderate, or severe mental retardation (i.e., documented intelligence quotient
             [IQ] <70) established by previous IQ testing or history

          -  Women who are pregnant (as confirmed by urine pregnancy test performed at screening or
             baseline), planning to become pregnant or are nursing

          -  Have a known or suspected history of seizure disorder, or neuroleptic malignant
             syndrome, encephalopathic syndrome, tardive dyskinesia, or insulin dependent diabetes
             mellitus

          -  Presence of any significant or unstable cardiovascular, respiratory, renal, hepatic,
             hematologic, endocrine, immunologic, or other systemic disease