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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

All Individual Drugs Already Approved

Approved for 20 Other Conditions

Pivotal Trial

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 6 and 10

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Repetitive Behavior Scale-revised

Other study objectives

ADI-R Item 16 for social vocalization/chat

Aberrant Behavior Checklist-Irritability subscale

Attention-Deficit-Hyperactivity Disorder Rating Scale-Revised IV

+1 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 20 Other Conditions

This treatment demonstrated efficacy for 20 other conditions.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

0 / 5Eligibility criteria met