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Therapeutic Issues for Autism

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Risperidone
hyperbaric oxygen therapy
Non specific Multivitamin
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism, Childhood Autism Rating Scale, Hyperbaric oxygen, Risperidone

Eligibility Criteria

5 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    The Hyperbaric oxygen therapy group

    The Risperidone group

    The HBOT and Risperidone group

    The Control group

    Arm Description

    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

    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.

    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

    This group consists of twenty autistic children received placebo in the form of multivitamins

    Outcomes

    Primary Outcome Measures

    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
    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)

    Secondary Outcome Measures

    Full Information

    First Posted
    March 19, 2019
    Last Updated
    March 20, 2019
    Sponsor
    Minia University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03887754
    Brief Title
    Therapeutic Issues for Autism
    Official Title
    Therapeutic Issues for Autism Spectrum Disorders: a Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2016 (Actual)
    Primary Completion Date
    January 2018 (Actual)
    Study Completion Date
    December 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Minia University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autism Spectrum Disorder
    Keywords
    Autism, Childhood Autism Rating Scale, Hyperbaric oxygen, Risperidone

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    Children were divided into four groups.Twenty autistic children in each group. They followed up for 2 years.
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    The Hyperbaric oxygen therapy group
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    The Risperidone group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    The HBOT and Risperidone group
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    The Control group
    Arm Type
    Placebo Comparator
    Arm Description
    This group consists of twenty autistic children received placebo in the form of multivitamins
    Intervention Type
    Drug
    Intervention Name(s)
    Risperidone
    Other Intervention Name(s)
    Resperidal
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    hyperbaric oxygen therapy
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Non specific Multivitamin
    Intervention Description
    control group received non specific multivitamins as placebo for 8 months.
    Primary Outcome Measure Information:
    Title
    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
    Description
    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)
    Time Frame
    two years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    7 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Usama Aly, PhD
    Organizational Affiliation
    Minia University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Khaled Khaled, Prof.
    Organizational Affiliation
    Minia University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25478714
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    28301358
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    17439697
    Citation
    Calvert JW, Cahill J, Zhang JH. Hyperbaric oxygen and cerebral physiology. Neurol Res. 2007 Mar;29(2):132-41. doi: 10.1179/016164107X174156.
    Results Reference
    background
    PubMed Identifier
    22703610
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26045648
    Citation
    LeClerc S, Easley D. Pharmacological therapies for autism spectrum disorder: a review. P T. 2015 Jun;40(6):389-97.
    Results Reference
    background
    PubMed Identifier
    10956571
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    21818676
    Citation
    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.
    Results Reference
    background

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