Therapeutic Issues for Autism

Minia University

Status and phase: Completed; Phase 2

Conditions: Autism Spectrum Disorder

Treatments: Drug: Non specific Multivitamin; Drug: Risperidone; Device: hyperbaric oxygen therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03887754

Autism Spectrum Disorder

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 5 to 7 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 4 patient groups, including a placebo group

The Hyperbaric oxygen therapy group

Active Comparator group

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

Treatment:

Device: hyperbaric oxygen therapy

The Risperidone group

Active Comparator group

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.

Treatment:

Drug: Risperidone

The HBOT and Risperidone group

Active Comparator group

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

Treatment:

Device: hyperbaric oxygen therapy

Drug: Risperidone

The Control group

Placebo Comparator group

Description:

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

Treatment:

Drug: Non specific Multivitamin