Long-term Antipsychotic Pediatric Safety Trial

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Main LAP01 study: The purpose is to evaluate the long-term pathologic weight changes associated with multi-year risperidone or aripiprazole therapy in 3 - \<18-year-old children, who have varying durations of prior antipsychotic drug exposure from the start of study Month 0 (M0). This is critical because children appear to have greater vulnerability to antipsychotic-associated weight gain than adults, and obesity has significant effects on morbidity and mortality. An additional sub-study (registry sub-study) was added via a protocol amendment. This registry sub-study is optional for participants and only participants who participate in the main study are eligible if they were 6 to less than 18 years of age at the time of the M0 visit. Participants who consent to this registry sub-study will participate in yearly in-person visits and complete monthly assessments remotely over the course of two additional years from the time of their final visit of the main LAP01 study.

About this trial record page

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Public field values for ClinicalTrials.gov record NCT03522168, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.

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Last update posted Apr 6, 2026 · Synced Sep 2, 2026

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