drugset / Trial / NCT04725383
Amitriptyline for Repetitive Behaviors in Autism Spectrum Disorders
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The investigators will recruit 30 children and adolescents (15 per group x 2 groups) aged 6 to 17 years with ASD and significant repetitive behaviors that cause problems to them and to others around them. Subjects will be randomized to either amitriptyline (AMI), dosed flexibly according to response and tolerability with a maximum dose of 100mg per day or 1.5mg/kg/day, in divided doses to minimize side effects, or placebo in look-alike capsules, for 10 weeks. Rating scales will be used to measure outcomes.
Timeline
- Start
- 2023-11-01
- Primary completion
- 2025-05-23
- Completion
- 2025-05-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amitriptyline | Small molecule | — | — |