TERMINATED

Amitriptyline for Repetitive Behaviors in Autism Spectrum Disorders

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Conditions

Autism Spectrum DisorderRepetitive Compulsive Behavioramitriptylineautismrepetitive behaviors

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-11-01
Study Completion:2025-05-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT04725383

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.

Ages Eligible for Study:6 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * males and females
  2. * ages 6-17 years;
  3. * 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)
  4. * Intellectual Disability if present to be no greater than moderate by history (ie IQ\>35).
  1. * 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,
  2. * QTc on EKG of 440 or more
  3. * absence of a reliable caregiver
  4. * amitriptyline allergy
  5. * previous neuroleptic malignant syndrome
  6. * seizures in the past 3 months
  7. * bipolar mood disorder
  8. * current or past psychosis
  9. * unstable medical illness
  10. * previous adequate trial of amitriptyline
  11. * using other psychotropic medications apart from melatonin for sleep or lorazepam 1mg as needed up to once a day for severe outbursts.

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Missouri, Kansas City

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-01
Study Completion Date2025-05-23

Study Record Updates

Study Start Date2023-11-01
Study Completion Date2025-05-23

Terms related to this study

Keywords Provided by Researchers

  • amitriptyline
  • autism
  • repetitive behaviors

Additional Relevant MeSH Terms

  • Autism Spectrum Disorder
  • Repetitive Compulsive Behavior