Open-label Study of Flexible-dose Paliperidone ER (Extended Release) to Treat Adolescent Schizophrenia.
Condition: Schizophrenia; Schizophrenic Disorders; Psychotic Disorders; Dementia Praecox
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this open-label study is to evaluate the long-term (6-month) safety and
      tolerability of extended-release paliperidone, an atypical antipsychotic, given in flexible
      dosages to adolescents with schizophrenia.
    

Detailed description: 
      This is a 6-month, open-label study (the patient, investigator, and sponsor know the study
      drug and dosage being taken by the patient) of the safety and tolerability of flexible-dose
      (1.5 to 12mg per day), extended-release (ER) paliperidone in adolescents with a diagnosis of
      schizophrenia. Patients who have completed study R076477PSZ3001 or who discontinued from that
      study because of lack of efficacy but completed a minimum of 21 days of the study may enter
      this study. Patients may also enter this study directly without participating in
      R076477PSZ3001. This study consists of a 21-day screening and washout phase (to discontinue
      and "wash out" any medication not allowed in the study), an open-label treatment phase of up
      to 26 weeks during which all patients will take oral paliperidone ER every day, and a
      post-treatment phase consisting of a follow-up visit completed 1 week after a patient has
      received the final dose of paliperidone ER. The study, including the screening and
      posttreatment phase, will last approximately 30 weeks. Screening and washout may be conducted
      while a patient is either an inpatient or an outpatient. Safety will be assessed by
      laboratory measurements (chemistry, liver function tests, hematology, hormone, lipid
      assessments, prolactin [blinded], urinalysis, and urine drug screens); body weight, height,
      and waist circumference measurements; ECGs; and physical examinations (including Tanner
      staging). The Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale
      (BARS), and Simpson Angus Rating Scale (SAS) will be used to assess extrapyramidal symptoms
      (EPS) and dyskinesias. Adverse events will be monitored including psychiatric adverse events
      of interest (i.e., suicide and related phenomena, homicidal ideation, depressed mood, and
      worsening of psychosis) that may be associated with paliperidone ER in this population. The
      primary aim of this study is to evaluate the long-term (6-month) safety and tolerability of
      paliperidone ER in adolescents with schizophrenia. As exploratory secondary aims, the study
      will assess the effect of paliperidone ER on the long-term symptoms of schizophrenia as
      measured by the changes in the Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
      scores, the global improvement in severity of illness as measured by the Clinical Global
      Impression-Severity (CGI-S) scale, the benefits in psychological, social, and school
      functioning as measured by the Children's Global Assessment Scale (CGAS), the changes in
      multiple domains of cognitive functioning measured by the modified Measurements and Treatment
      Research to Improve Cognition in Schizophrenia (MATRICS) assessment battery, and the effect
      on sleep as measured by the sleep Visual Analog Scale (VAS). Patients begin the study at 6.0
      mg/day of oral paliperidone ER. If a higher dosage is needed, the dosage will be increased
      (in increments of 3 mg/day not more frequently than once every 5 days) to 12 mg/day. If the
      6.0 mg/day dosage is not well tolerated, the dosage may be decreased (not more frequently
      than once every 5 days) to 3.0 mg/day or 1.5 mg/day. Patients will be dosed for up to 6
      months.
    

Intervention name(s): Paliperidone ER
Intervention type(s): Drug
Intervention description(s): 1.5 to 12 mg tablet once daily for 6 months
Intervention MeSH terms: Paliperidone Palmitate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Adolescent; Paliperidone; Antipsychotic agents; Antipsychotic drugs; Psychosis.