Schizophrenia Clinical Trial
Official title:
Evaluation of Growth, Sexual Maturation, and Prolactin-Related Adverse Events in the Pediatric Population Exposed to Atypical Antipsychotic Drugs
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.
Status | Completed |
Enrollment | 244 |
Est. completion date | July 2011 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 8 Years to 16 Years |
Eligibility |
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 |
Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
United States, Belgium, Germany, Greece, Netherlands, Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Height (cm) Z-score at Study Visit | Height (cm) measured at the study visit was converted to a Z-score based on the US Center for Disease Control 2000 growth charts for US subjects and European growth charts for ex-US subjects. A z-score indicates how many standard deviations a subject is away from the expected height for the subject's age and gender. | One single study visit, approximately one week after informed consent has been obtained | Yes |
Secondary | Age (Years) at Current Tanner Stage | Tanner stage is an evaluation of pubertal development with values ranging from 1 (pre-pubertal) to 5 (adult). A standardized, validated tool containing standardized pictures and written descriptions of the stages of pubic hair development, breast development for girls, and genital development for boys was used by physicians to make their assessment. | One single study visit, approximately one week after informed consent has been obtained | Yes |
Secondary | Number of Participants With Retrospectively Reported Potentially Prolactin-Related Adverse Events | Previous potentially prolactin-related adverse events, including hyperprolactinemia, were reviewed and abstracted from participants' medical records. Potentially prolactin-related adverse events include breast symptoms, menstrual disorders, hyperprolactinemia, and prolactinoma. | Retrospectively during the time of exposure for up to 2 years prior to the study visit | Yes |
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