NCT03887754

Therapeutic Issues for Autism

Therapeutic Issues for Autism Spectrum Disorders: a Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Minia University · Academic / Other
• Sex: All
• Age: 5 Years – 7 Years
• Healthy volunteers: Accepted

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.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-01-01
• Completion: 2018-12-01
• First posted: 2019-03-25
• Last updated: 2019-03-25

Regulatory

• FDA-regulated drug study