- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04725383
Amitriptyline for Repetitive Behaviors in Autism Spectrum Disorders
Amitriptyline for Repetitive Behaviors in Children and Adolescents With Autism Spectrum Disorders
Study Overview
Status
Intervention / Treatment
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 EKG and complete rating scales, as well as a pregnancy test (beta-HCG) in sexually active females of childbearing age. Sexually active females of childbearing age must be on a form of birth control during the study, such as the oral contraceptive pill, intrauterine device or Depo Provera shot. A parent or guardian will sign informed consent, as appropriate, and written assent will be obtained from subjects. Blood tests for CBC and diff, CMP, amitriptyline level will be obtained at at baseline (except for amitriptyline) week 6 and 10.
Subjects will be randomized to amitriptyline (AMI) or placebo. Parents and guardians will be instructed to lock up all medications, warned regarding overdose toxicity and this will be documented in writing. Treatment will be low dose AMI or placebo for 12 weeks. Study visits will occur at weeks 0,1, 2, 3, 4, 5, 6, 8, and 10.
Investigators will complete a Clinical Global Impressions scale (CGI), and have the accompanying adult or parent complete rating scales, at each visit, notably the Child Yale Brown Obsessive Compulsive scale modified for Pervasive Developmental Disorder (CYBOCS-PDD), Aberrant Behavior Checklist-Irritability subscale (ABC-I), Repetitive Behavior Scale-Revised (RBS-R), ADHD-RS, adverse events form, ADI-R item 11 for phrase speech, and a concomitant treatment review form, which will also detail for example any over-the-counter medications, supplements or antibiotics taken. Also a gastrointestinal symptom form based on that used by Valicenti-McDermott et al. 2008.
At all interim visits, the PI will perform a follow-up history taking, mental status examination, vital signs, rating scales as above and study drug dispensing. Any unused capsules must be returned at each visit, to monitor compliance as well as to prevent accidental overdose. Parents and caregivers will agree to lock medication up, and will be reminded of overdose toxicity at each study visit, with written documentation.
Flexible dosing, arranged by calling the pharmacy to randomize the subject and then dispense and mail study capsules, according to the psychiatrist's instructions at each visit, to a maximum dose of 100mg/day or 1.5mg/kg/day maximum by subject weight.
Individuals and their parents or guardians will be questioned about suicidal ideation at each visit, and instructed to call study staff if that should arise. At that time the PI will arrange an urgent visit to closely assess risks of remaining in the study. In our experience suicidal ideation has not occurred. Subjects may drop out at any time however, and in the unlikely case, if warranted, be admitted to hospital for close observation.
The study will be double- blind and placebo-controlled. All investigators except a psychiatry co-investigator will be blinded, as will caregivers, families and subjects.
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Jessica A Hellings, MD
- Phone Number: 816-404-6202
- Email: Jessica.Hellings@uhkc.org
Study Contact Backup
- Name: Zamani Ishrath
- Email: ishrath.zamani@umkc.edu
Study Locations
-
-
Missouri
-
Kansas City, Missouri, United States, 64108
- Recruiting
- University Health Behavioral Health Canvas Building
-
Contact:
- Jessica A Hellings, MD
- Phone Number: 816-404-6170
- Email: Jessica.Hellings@uhkc.org
-
Contact:
- Ishrath Zamani
- Email: ishrath.zamani@umkc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion 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).
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: amitriptyline
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.
|
Amitriptyline is a tricyclic antidepressant being studied off-label here for repetitive behaviors in autism spectrum disorders.
Other Names:
|
Placebo Comparator: placebo
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.
|
Amitriptyline is a tricyclic antidepressant being studied off-label here for repetitive behaviors in autism spectrum disorders.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Global Impressions scale-Improvement of Much Improved (2) or Very Much Improved (1)
Time Frame: up to 10 weeks
|
1 Very Much Improved to 7 Very Much Worse
|
up to 10 weeks
|
Child Yale Brown Obsessive Compulsive Scale- Pervasive Developmental Disorders (CYBOCS-PDD)
Time Frame: up to 10 weeks
|
0-20; high scores are more severe
|
up to 10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Repetitive Behavior Scale-revised
Time Frame: up to week 10
|
0-129; high scores are more severe
|
up to week 10
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Social Responsiveness scale-2
Time Frame: Baseline, week 10
|
34-90; high scores are more severe
|
Baseline, week 10
|
Attention-Deficit-Hyperactivity Disorder Rating Scale-Revised IV
Time Frame: up to week 10
|
0-54; high scores are more severe
|
up to week 10
|
Aberrant Behavior Checklist-Irritability subscale
Time Frame: up to week 10
|
0-45; high scores are more severe
|
up to week 10
|
ADI-R Item 16 for social vocalization/chat
Time Frame: baseline, week 6 and 10
|
0-3; highest scores indicate poorest
|
baseline, week 6 and 10
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jessica A. Hellings, MD, University of Kansas City-Missouri and Truman Behavioral Health
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Neurodevelopmental Disorders
- Impulsive Behavior
- Autistic Disorder
- Autism Spectrum Disorder
- Child Development Disorders, Pervasive
- Compulsive Behavior
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Antidepressive Agents, Tricyclic
- Adrenergic Uptake Inhibitors
- Amitriptyline
Other Study ID Numbers
- 2015984
- 17-055 (Truman Medical Center)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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