Amitriptyline for Repetitive Behaviors in Autism Spectrum Disorders

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Autism Spectrum Disorder, Repetitive Compulsive Behavior

In brief

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.

Key facts

Study ID

NCT04725383

Run by

University of Missouri, Kansas City

People needed

1

Starts

2023-11-01

Expected to finish

2025-05-23

Last updated by the study team

2025-05-30

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• University Health Behavioral Health Canvas Building — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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