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

Completed · Phase 4

Conditions studied: Schizophrenia, Bipolar Disorder, Autistic Disorder, Conduct and Other Disruptive Behavior Disorders

In brief

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.

Key facts

Study ID

NCT01050582

Run by

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

People needed

244

Starts

2009-10-01

Expected to finish

2011-07-01

Last updated by the study team

2012-11-27

Who can join

Age: 8 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Study site — San Francisco, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Altamonte Springs, Florida, United States
• Study site — Gainesville, Florida, United States
• Study site — Smyrna, Georgia, United States
• Study site — Naperville, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Valparaiso, Indiana, United States
• Study site — Boston, Massachusetts, United States
• Study site — Cambridge, Massachusetts, United States
• Study site — Glen Oaks, New York, United States
• Study site — Cleveland, Ohio, United States
• Study site — Columbus, Ohio, United States
• Study site — Antwerp, Belgium
• Study site — Freiburg im Breisgau, Germany
• Study site — Jena, Germany
• Study site — Mannheim, Germany
• Study site — München, Germany
• Study site — Tübingen, Germany
• Study site — Ulm, Germany
• Study site — Würzburg, Germany
• Study site — Athens, Greece
• Study site — Nijmegen, Netherlands
• Study site — Gdansk, Poland
• Study site — Kielce, Poland

Full record on ClinicalTrials.gov

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