At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 244 enrolled
Drug / intervention
Risperidone +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of Growth, Sexual Maturation, and Prolactin-Related Adverse Events in the Pediatric Population Exposed to Atypical Antipsychotic Drugs
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·interventional·Posted Jan 15, 2010·Updated Nov 27, 2012
In Brief
A Phase 4 clinical trial evaluating Risperidone and Other atypical antipsychotic drugs for Schizophrenia and 3 related conditions. Completed, enrolled 244 participants across 28 sites in 6 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia, Bipolar Disorder, Autistic Disorder, Conduct and Other Disruptive Behavior Disorders
CountriesBelgium, Germany, Greece, Netherlands, Poland, United States
Collaborators--
Timeline
Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2009
First PostedJan 2010
Primary CompletionJul 2011
TodayJul 2026
First PostedJan 15, 2010
Enrollment StartOct 1, 2009
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.5 years ago
Interventions
Risperidonedrug
As per local prescribing practices
Other atypical antipsychotic drugsdrug
As per local prescribing practices