Amitriptyline for Repetitive Behaviors in Autism Spectrum Disorders

• Status: Not yet recruiting
• Trial end date: 2024-12-20
• Target enrollment: 0
• Participant gender: All

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 12 weeks. Rating scales, and eye-tracking will be used to measure outcomes.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Missouri, Kansas City
• Treatments: Amitriptyline; Amitriptyline, perphenazine drug combination

Criteria

Inclusion Criteria:

• males and females

• ages 6-17 years;

• diagnosis of ASD validated by the Autism Diagnostic Interview- Revised (Lord et al. 1994); CGI-S rating of at least Moderate problem CYBOCS-PDD score of at least 8 or more for compulsive behaviors (sum of items 1A, 2, 3 and 5)

• Intellectual Disability if present to be no greater than moderate by history (ie IQ>35).

Exclusion Criteria:

• unable to complete an EKG recording, even with low dose risperidone and alprazolam if needed an hour before, and repeated at the time (if needed), of the procedure,

• QTc on EKG of 440 or more

• absence of a reliable caregiver

• amitriptyline allergy

• previous neuroleptic malignant syndrome

• seizures in the past 3 months

• bipolar mood disorder

• current or past psychosis

• unstable medical illness

• previous adequate trial of amitriptyline

• using other psychotropic medications apart from melatonin for sleep or lorazepam 1mg as needed up to once a day for severe outbursts.