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Tricyclic Antidepressant

Amitriptyline for Autism

Phase 3
Recruiting
Led By Jessica A. Hellings, MD
Research Sponsored by University of Missouri, Kansas City
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages 6-17 years
Be younger than 18 years old
Must not have
Seizures in the past 3 months
Previous adequate trial of amitriptyline
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 6 and 10
Awards & highlights

Summary

This trial will study the effects of amitriptyline and placebo on 30 children/adolescents with Autism Spectrum Disorder and serious repetitive behaviors. Outcomes will be measured with rating scales.

Who is the study for?
This trial is for children and adolescents aged 6-17 with Autism Spectrum Disorder (ASD) who exhibit significant repetitive behaviors. Participants must have a confirmed diagnosis of ASD, a moderate problem rating on the CGI-S scale, and score at least an 8 on the CYBOCS-PDD for compulsive behaviors. They should not have severe intellectual disability, bipolar disorder, past psychosis, certain heart issues (QTc of 440+), or recent seizures.Check my eligibility
What is being tested?
The study tests amitriptyline against a placebo in managing repetitive behaviors in ASD patients over ten weeks. The drug's dose will be adjusted based on response and side effects but won't exceed 100mg/day or 1.5mg/kg/day. Outcomes are measured using rating scales to track changes in behavior.See study design
What are the potential side effects?
Amitriptyline may cause drowsiness, dry mouth, blurred vision, constipation, weight gain and urinary retention. It can also affect heart rhythms which is why participants with certain EKG results are excluded from the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 6 and 17 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had seizures in the last 3 months.
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I have previously tried amitriptyline without success.
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I only use melatonin for sleep or lorazepam 1mg once a day for severe outbursts.
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I have been diagnosed with bipolar disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 6 and 10
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 6 and 10 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Child Yale Brown Obsessive Compulsive Scale- Pervasive Developmental Disorders (CYBOCS-PDD)
Clinical Global Impressions scale-Improvement of Much Improved (2) or Very Much Improved (1)
Secondary outcome measures
Repetitive Behavior Scale-revised
Other outcome measures
ADI-R Item 16 for social vocalization/chat
Aberrant Behavior Checklist-Irritability subscale
Attention-Deficit-Hyperactivity Disorder Rating Scale-Revised IV
+1 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: amitriptylineActive Control1 Intervention
Subjects will receive active amitriptyline compounded into look-alike capsules to resemble placebo capsules. Dosing will be as tolerated, up to tid and maximum of 100mg/day or 1.5mg/kg/day, for 10 weeks.
Group II: placeboPlacebo Group1 Intervention
Subjects in this arm will receive placebo compounded into capsules that resemble the compounded amitriptyline capsules, up to 4 capsules a day (1 qam, 1 q4pm and 2 capsules qhs), for 10 weeks.

Find a Location

Who is running the clinical trial?

University of Missouri, Kansas CityLead Sponsor
69 Previous Clinical Trials
32,590 Total Patients Enrolled
Jessica A. Hellings, MDPrincipal InvestigatorUniversity of Kansas City-Missouri and Truman Behavioral Health
~16 spots leftby Jun 2025
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