A Study to Evaluate the Safety and the Effects of Risperidone Compared With Other Atypical Antipsychotic Drugs on the Growth and Sexual Maturation in Children
Condition: Schizophrenia; Bipolar Disorder; Autistic Disorder; Conduct and Other Disruptive Behavior Disorders
MeSH terms: Schizophrenia; Bipolar Disorder; Autistic Disorder; Mental Disorders; Problem Behavior; Attention Deficit and Disruptive Behavior Disorders
Intervention: Risperidone; Other atypical antipsychotic drugs
Intervention description: As per local prescribing practices; As per local prescribing practices
Intervention MeSH terms: Risperidone; Antipsychotic Agents
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 244.0
Sex: All
Minimum age: 8 Years
Maximum age: 16 Years
Healthy volunteers: No
Keywords: Schizophrenia; Bipolar Disorder; Autistic Disorder; Conduct and Other Disruptive Behavior Disorders; Risperidone; RISPERDAL; Antipsychotic Agents; Prolactin; Pediatrics

Summary:

      The purpose of this study is to evaluate the effects of risperidone compared with other
      atypical antipsychotic drugs on the physical maturity, growth and development of children,
      and the risk of prolactin-related adverse events (side effects) associated to these drugs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  One or both parents (according to local regulations) or a guardian must have signed an
             informed consent document indicating that they understand the purpose of and
             procedures required for the study and are willing to participate in the study (If
             appropriate according to local regulations, the patient must also assent)

          -  Treated for schizophrenia, bipolar mania, autistic disorder, or conduct and other
             disruptive behavior disorders

          -  Had at least 6 months of exposure for an atypical antipsychotic drug within 24 months
             before the study visit (patients may or may not be taking the atypical antipsychotics
             at the time of actual enrollment, eligible patients can have exposure to multiple
             atypical antipsychotics, however, they cannot concomitantly be exposed to more than 1
             atypical antipsychotic for a period of greater than 30 days)

          -  Had medical records or automated data available for at least 1 year prior to the start
             of exposure

          -  Height and weight were recorded at least once within 1 year before the start of
             exposure, and if available at any time points after the start of exposure in the
             medical records or electronic databases (not mandatory)

        Exclusion Criteria:

          -  Have at least 1 medical record, at any time before the start of exposure, consistent
             with malignancy (other than non-melanoma skin cancer), pregnancy, or a developmental
             delay or abnormality associated with growth or sexual maturation delays not related to
             the specified indications

          -  Had exposure to prolactin elevating medications other than atypical antipsychotics and
             selective serotonin reuptake inhibitors (SSRIs)

          -  Had exposure to Paliperidone

          -  Cannot comply with study procedures