Amitriptyline for Repetitive Behaviors in Autism Spectrum Disorders

Description

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.

Conditions

Autism Spectrum Disorder, Repetitive Compulsive Behavior

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Study Overview

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Study Details

Study overview

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.

Amitriptyline for Repetitive Behaviors in Children and Adolescents With Autism Spectrum Disorders

Amitriptyline for Repetitive Behaviors in Autism Spectrum Disorders

Condition
Autism Spectrum Disorder
Intervention / Treatment

-

Contacts and Locations

Kansas City

University Health Behavioral Health Canvas Building, Kansas City, Missouri, United States, 64108

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • * 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.

Ages Eligible for Study

6 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Missouri, Kansas City,

Jessica A. Hellings, MD, PRINCIPAL_INVESTIGATOR, University of Kansas City-Missouri and Truman Behavioral Health

Study Record Dates

2025-05-23