Evaluation of Growth, Sexual Maturation, and Prolactin-Related Adverse Events in the Pediatric Population Exposed to Atypical Antipsychotic Drugs

Janssen-Cilag International, NV0 sites350 target enrollmentJanuary 11, 2011

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: ong-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.
Sponsor: Janssen-Cilag International, NV
Enrollment: 350
Status: Active, not recruiting
Last Updated: 14 years ago

No summary available.

Registry

who.int

Start Date

January 11, 2011

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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

•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.