drugset / Trial / NCT01731119
Study of Lurasidone in Treating Antipsychotic Naive or Quasi-Naive Children and Adolescents
Phase 2
Completed
9 enrolled
University of North Carolina, Chapel Hill
Foundation of Hope, North Carolina · collab
NaSingle-groupOpen-labelTreatment
Summary
The overarching purpose of this pilot study is to collect preliminary data regarding the variability of weight gain associated with lurasidone (Latuda©) treatment of antipsychotic naive children and adolescents in order to inform decisions about including a lurasidone arm in a future large scale trial of different approaches to minimize antipsychotic associated weight gain in the pediatric population. In adults, lurasidone appears to cause minimal weight gain. The participants will be 6-19 years old with psychotic spectrum, mood spectrum, or autism spectrum disorders. They will have 4 weeks or less of lifetime antipsychotic exposure.
Timeline
- Start
- 2012-12
- Primary completion
- 2014-08
- Completion
- 2014-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lurasidone | Small molecule | 20 mg | — |
| Subject | Lurasidone | Small molecule | 40 mg | — |
| Subject | Lurasidone | Small molecule | 160 mg | — |