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Therapeutic Issues for Autism

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ClinicalTrials.gov Identifier: NCT03887754
Recruitment Status : Completed
First Posted : March 25, 2019
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Asmaa Salah, Minia University

Brief Summary:
This study aimed to show the effects of hyperbaric oxygen therapy and/or Risperidone in improving symptoms of autism

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Drug: Risperidone Device: hyperbaric oxygen therapy Drug: Non specific Multivitamin Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Children were divided into four groups.Twenty autistic children in each group. They followed up for 2 years.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Therapeutic Issues for Autism Spectrum Disorders: a Clinical Trial
Actual Study Start Date : January 2016
Actual Primary Completion Date : January 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Risperidone

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
Device: hyperbaric oxygen therapy
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.

Drug: Risperidone
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 Name: Resperidal

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
Drug: Risperidone
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 Name: Resperidal

Device: hyperbaric oxygen therapy
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.

Placebo Comparator: The Control group
This group consists of twenty autistic children received placebo in the form of multivitamins
Drug: Non specific Multivitamin
control group received non specific multivitamins as placebo for 8 months.




Primary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   5 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03887754


Sponsors and Collaborators
Minia University
Investigators
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Study Chair: Usama Aly, PhD Minia University
Study Director: Khaled Khaled, Prof. Minia University

Publications:
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Responsible Party: Asmaa Salah, principal investigator, Minia University
ClinicalTrials.gov Identifier: NCT03887754     History of Changes
Other Study ID Numbers: Autism Spectrum Disorder
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Asmaa Salah, Minia University:
Autism
Childhood Autism Rating Scale
Hyperbaric oxygen
Risperidone

Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents