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

• 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.; MedDRA version: 12.1Level: LLTClassification code 10039626Term: Schizophrenia; MedDRA version: 12.1Level: HLGTClassification code 10026753Term: Manic and bipolar mood disorders and disturbances; MedDRA version: 12.1Level: LLTClassification code 10003805Term: Autism

• Registration Number: EUCTR2009-012003-26-GR
• Lead Sponsor: Janssen-Cilag International, NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 350

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - To evaluate the effects of risperidone as compared with other atypical antipsychotic medications on child growth and sexual maturation <br>-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.