drugset / Trial / NCT04725383

Amitriptyline for Repetitive Behaviors in Autism Spectrum Disorders

NCT04725383

Phase 3 Terminated 1 enrolled University of Missouri, Kansas City
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

EvaluationDrugModalityDoseRoute
Comparator Amitriptyline Small molecule