Last reviewed · How we verify
NCT03522168: LAPS
Long-term Antipsychotic Pediatric Safety Trial
trial testing Risperidone in Weight, Body in 509 participants. Completed in 21 November 2023.
21 November 2023
Quick facts
| Lead sponsor | Duke University |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 509 |
| Start date | 10 January 2019 |
| Primary completion | 21 November 2023 |
| Estimated completion | 21 November 2023 |
| Sites | 37 locations across United States |
Drugs / interventions tested
- Risperidone (risperidone) — full drug profile →
- Aripiprazole (aripiprazole) — full drug profile →
Conditions studied
- Weight, Body — all drugs for Weight, Body →
Sponsor
Duke University
Who can join
Adults 3 to 18, any sex, with Weight, Body. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03522168
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Risperidone
Trials testing the same drug.
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- NCT07483294 — Cerebellum-based Imaging Neural Markers for Antipsychotic Response · recruiting
- NCT07060872 — the Effect of Formulation on Anxiety in Autist Childre A Randomized Controlled Trial Assesses Spirulina Syrup Plus Rispe · NA · not yet recruiting
- NCT06236451 — Atypical Antipsychotic-induced Mitochondrial Dysfunction in Patients With Schizophrenia · Phase 4 · completed
- NCT06368726 — Result of tDCS in ASD Children With Comorbidities Like PANDAS, Rare Genetic Diseases or Autoimmune Disorders · Phase 1 · enrolling by invitation
Other recruiting trials for Weight, Body
Currently open trials in the same condition.
- NCT06528067 — Mindful Motivation for Reducing Binge Eating · NA · active not recruiting
- NCT05899205 — Patient Recorded Indexing Measurements · recruiting
- NCT04537988 — ECHANGE: EHealth Design to Facilitate Weight Maintenance Following Initial Weight Loss · NA · active not recruiting
Other Duke University trials
Trials by the same sponsor.
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- NCT07216963 — The Community Paramedic Response and Overdose Outreach With Supportive Medical-Legal Services Study · NA · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03522168 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Duke University
- Last refreshed: 7 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03522168.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing