Long-term safety data in children and adolescents will be collected from a population of patients with a diagnosis of schizophrenia, bipolar mania, autistic disorder or conduct and other disruptive disorders undergoing routine standard of care treatment. MedDRA version: 12.1 Level: LLT Classification code 10039626 Term: Schizophrenia MedDRA version: 12.1 Level: HLGT Classification code 10026753 Term: Manic and bipolar mood disorders and disturbances MedDRA version: 12.1 Level: LLT Classificat
Conditions
Interventions
Trade Name: RISPERDAL
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: RISPERIDONE
CAS Number: 106266-06-2
Current Sponsor code: R064766
Other descriptive name: RISPERIDONE
Concentration u
Sponsors
Janssen-Cilag International, NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Boys and girls 8 to 16 years of age. 2.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 subject must also assent. 3.Treated for schizophrenia, bipolar mania, autistic disorder, or conduct and other disruptive behavior disorders. 4.Had at least 6 months of exposure for an atypical antipsychotic drug within 24 months before the study visit; subjects may or may not be taking the atypical antipsychotics at the time of actual enrollment; eligible subjects can have exposure to multiple atypical antipsychotics. However, they cannot concomitantly be exposed to more than one atypical antipsychotic for a period of >30days (to allow for cross-taper) (Section12.2.). 5.Had medical records or automated data available for at least 1 year prior to the start of exposure. 6.Height and weight were recorded at least once within one 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). Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Have at least 1medical 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 (Section12.3.). 2.Had exposure to prolactin elevating medications (Section 12.1.2.) other than atypical antipsychotics and selective serotonin reuptake inhibitors (SSRIs). 3.Had exposure to Paliperidone. 4.Cannot comply with study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To evaluate the effects of risperidone as compared with other atypical antipsychotic medications on child growth and sexual maturation -To evaluate the risk of other prolactin-related adverse events associated with risperidone as compared with other atypical antipsychotic medications in a pediatric population;Secondary Objective: The secondary objective is to assess the prolactin value and risk of hyperprolactinemia associated with risperidone as compared with other atypical antipsychotic medications in a pediatric population. ;Primary end point(s): To evaluate the effects of Risperidone as compared with other atypical antipsychotic medications on child growth through the collection of data on height, weight and tanner stage. | — |
Countries
Greece, Netherlands
Outcome results
None listed