Therapeutic Issues for Autism
Autism Spectrum Disorder
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
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
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
The Hyperbaric oxygen therapy group
The Risperidone group
The HBOT and Risperidone group
The Control 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
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