Status:
TERMINATED
Amitriptyline for Repetitive Behaviors in Autism Spectrum Disorders
Lead Sponsor:
University of Missouri, Kansas City
Conditions:
Autism Spectrum Disorder
Repetitive Compulsive Behavior
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
Brief 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 t...
Detailed Description
At the screening visit, investigators will perform a full history-taking, mental status examination, physical and neurological examinations, the ADI-R with a caregiver or parent to confirm autism, an ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2025
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04725383
Start Date
November 1 2023
End Date
May 23 2025
Last Update
May 30 2025
Active Locations (1)
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1
University Health Behavioral Health Canvas Building
Kansas City, Missouri, United States, 64108