- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03887754
Therapeutic Issues for Autism
Therapeutic Issues for Autism Spectrum Disorders: a Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Autism spectrum disorders (ASDs) are clinical disorders with multiple developmental disabilities in skills associated with overall behavior and communication. The term (ASD) includes Autistic Disorder (AD), Pervasive Developmental Disorder-Not Otherwise Specified (PDD-NOS), and Asperger's Disorder .
Hyperbaric oxygen therapy (HBOT) is a treatment in which patients inside a hyperbaric chamber breathe a concentrated oxygen pressurized more than sea level (1 atmosphere absolute) .
It was obvious that autistic children may have some benefits of HBOT by increasing in cerebral perfusion during treatment. Inhalation of more pressurized oxygen might elevate partial pressure of oxygen in the arterial blood, and increased oxygen that reaches the brain . Another mechanism of action of HBOT that it might have anti-inflammatory properties by reduction of pro-inflammatory cytokines, interleukins 1 and 6, interferon-γ, and tumor necrosis factor-α. Furthermore, HBOT might enhance mitochondrial dysfunction, and upregulate the antioxidant enzymes production.
Risperidone is a second generation antipsychotic, approved by the Food and Drug Administration (FDA) for treatment of autism-related irritability. Its approved in 2006 only for children not less than 5 years old . This trial aimed to study the effects of hyperbaric oxygen therapy and/or Risperidone in management symptoms of autism.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age of 5-7 years
- weight of at least 15 kg
Exclusion Criteria:
- Absence of significant medical problems and any other neuropsychiatric disorder requiring drug therapy (e.g., Bipolar disorder, psychosis).
- No concomitant treatment with psychotropic medication was allowed during the study.
- Weight less than 15 kg.
- Other cardiac, liver, gastrointestinal, renal, endocrine, blood and metabolic diseases
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: The Hyperbaric oxygen therapy group
This group consists of twenty autistic children received forty sessions of HBOT, the time of the session is one hour.
The sessions were done at pressure 1.5 ATA (atmosphere absolute) and with 100% oxygen concentration, either in multiplace or monoplace chamber.
The number of sessions per week allowed is five sessions per week, all participants were required to complete forty sessions within two months.
After six months from the last session, another forty sessions would be taken in the same manner
|
Sessions were done at pressure 1.5 ATA (atmosphere absolute) with 100% oxygen concentration, each lasting for one hour either in multiplace chamber or in monoplace chamber.
|
Active Comparator: The Risperidone group
This group consists of twenty autistic children received Risperidone (dose: 0.25 mg per day in children weighing less than (20 kg); 0.5 mg per day in persons weighing more) for eight months. The medication schedule in the initial 2 months was based on the child's weight and clinical response. Adjusting the total daily dose according to response and/or adverse effects, at the end of these eight months of treatment we began the discontinuation phase. In this phase, gradual placebo substitution occurs. The discontinuation reduced the maintenance dose by 25% per week. Thus, the dose was 75% of the last week in the eight months for the first week, followed by 50% of the last week for the second week, 25% of the last week for the third week, and placebo only by the fourth week. |
It is antipsychotic drug used by dose: 0.25 mg per day in children weighing less than (20 kg); 0.5 mg per day in persons weighing more for 8 months.
Other Names:
|
Active Comparator: The HBOT and Risperidone group
This group consists of twenty autistic children received HBOT as the HBOT group in addition to Risperidone as the Risperidone group in the same manner and duration
|
Sessions were done at pressure 1.5 ATA (atmosphere absolute) with 100% oxygen concentration, each lasting for one hour either in multiplace chamber or in monoplace chamber.
It is antipsychotic drug used by dose: 0.25 mg per day in children weighing less than (20 kg); 0.5 mg per day in persons weighing more for 8 months.
Other Names:
|
Placebo Comparator: The Control group
This group consists of twenty autistic children received placebo in the form of multivitamins
|
control group received non specific multivitamins as placebo for 8 months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Childhood Autism Rating Scale version 2 (CARS2)measured after one year and after two years to compare the effect of hyperbaric oxygen therapy, Risperidone, both of them and the placebo effect
Time Frame: two years
|
The CARS is a 15 items behavioral rating scale developed to identify autism as well as to quantitatively describe the severity of the disorder.
The items are as follows: I. Relating to People; II.
Imitation; III.
Emotional Response; IV.
Body Use; V. Object Use; VI.
Adaptation to Change; VII.
Visual Response; VIII.
Listening Response; IX.
Taste; Smell, and Touch Response and Use; X. Fear or Nervousness; XI.
Verbal Communication; XII.
Nonverbal Communication; XIII.
Activity Level; XIV.
Level and Consistency of Intellectual Response; and XV.
General Impressions.
Each item is scored from 1 (no pathology) to 4 (severe pathology) in 0.5 intervals.
A total score of 15-29.5 is considered non-autistic to minimal; a score of 30-36.5 is considered mild to moderate autism; a score of 37-60 is considered severe autism (these are based on raw scores)
|
two years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Usama Aly, PhD, Minia University
- Study Director: Khaled Khaled, Prof., Minia University
Publications and helpful links
General Publications
- Zulauf Logoz M. [The Revision and 5th Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5): Consequences for the Diagnostic Work with Children and Adolescents]. Prax Kinderpsychol Kinderpsychiatr. 2014;63(7):562-76. doi: 10.13109/prkk.2014.63.7.562. German.
- Lam G, Fontaine R, Ross FL, Chiu ES. Hyperbaric Oxygen Therapy: Exploring the Clinical Evidence. Adv Skin Wound Care. 2017 Apr;30(4):181-190. doi: 10.1097/01.ASW.0000513089.75457.22.
- Calvert JW, Cahill J, Zhang JH. Hyperbaric oxygen and cerebral physiology. Neurol Res. 2007 Mar;29(2):132-41. doi: 10.1179/016164107X174156.
- Rossignol DA, Bradstreet JJ, Van Dyke K, Schneider C, Freedenfeld SH, O'Hara N, Cave S, Buckley JA, Mumper EA, Frye RE. Hyperbaric oxygen treatment in autism spectrum disorders. Med Gas Res. 2012 Jun 15;2(1):16. doi: 10.1186/2045-9912-2-16.
- LeClerc S, Easley D. Pharmacological therapies for autism spectrum disorder: a review. P T. 2015 Jun;40(6):389-97.
- Starkstein SE, Vazquez S, Vrancic D, Nanclares V, Manes F, Piven J, Plebst C. SPECT findings in mentally retarded autistic individuals. J Neuropsychiatry Clin Neurosci. 2000 Summer;12(3):370-5. doi: 10.1176/jnp.12.3.370.
- Bent S, Bertoglio K, Ashwood P, Nemeth E, Hendren RL. Brief report: Hyperbaric oxygen therapy (HBOT) in children with autism spectrum disorder: a clinical trial. J Autism Dev Disord. 2012 Jun;42(6):1127-32. doi: 10.1007/s10803-011-1337-3.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
- Mental Disorders
- Neurodevelopmental Disorders
- Child Development Disorders, Pervasive
- Autistic Disorder
- Autism Spectrum Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Dopamine Agents
- Serotonin Antagonists
- Dopamine Antagonists
- Risperidone
Other Study ID Numbers
- autism spectrum disorder
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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