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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

Tracking Information
First Submitted Date  ICMJE March 19, 2019
First Posted Date  ICMJE March 25, 2019
Last Update Posted Date March 25, 2019
Actual Study Start Date  ICMJE January 2016
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2019)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Therapeutic Issues for Autism
Official Title  ICMJE Therapeutic Issues for Autism Spectrum Disorders: a Clinical Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Autism Spectrum Disorder
Intervention  ICMJE
  • 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.
  • Drug: Non specific Multivitamin
    control group received non specific multivitamins as placebo for 8 months.
Study Arms  ICMJE
  • 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
    Intervention: Device: hyperbaric oxygen therapy
  • 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.

    Intervention: Drug: Risperidone
  • 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
    Interventions:
    • Drug: Risperidone
    • Device: hyperbaric oxygen therapy
  • Placebo Comparator: The Control group
    This group consists of twenty autistic children received placebo in the form of multivitamins
    Intervention: Drug: Non specific Multivitamin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 20, 2019)
80
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2018
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 7 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03887754
Other Study ID Numbers  ICMJE Autism Spectrum Disorder
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Asmaa Salah, Minia University
Study Sponsor  ICMJE Minia University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Usama Aly, PhD Minia University
Study Director: Khaled Khaled, Prof. Minia University
PRS Account Minia University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP