Therapeutic Issues for Autism

NCT03887754 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: Autism Spectrum Disorder
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Autism Spectrum Disorder

Keywords

Autism; Childhood Autism Rating Scale; Hyperbaric oxygen; Risperidone

Outcome Measures

Primary Outcomes (1)

• 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)

  two years

Study Arms (4)

The Hyperbaric oxygen therapy group

ACTIVE COMPARATOR

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

Device: hyperbaric oxygen therapy

The Risperidone group

ACTIVE COMPARATOR

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.

Drug: Risperidone

The HBOT and Risperidone group

ACTIVE COMPARATOR

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

Drug: Risperidone; Device: hyperbaric oxygen therapy

The Control group

PLACEBO COMPARATOR

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

Drug: Non specific Multivitamin

Interventions

Risperidone DRUG

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.

Also known as: Resperidal

The HBOT and Risperidone group; The Risperidone group

hyperbaric oxygen therapy DEVICE

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.

The HBOT and Risperidone group; The Hyperbaric oxygen therapy group

Non specific Multivitamin DRUG

control group received non specific multivitamins as placebo for 8 months.

The Control group

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• age of 5-7 years
• weight of at least 15 kg

You may not qualify if:

• 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

Sponsors & Collaborators

• Minia University: lead

Related Publications (7)

• 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.

  PMID: 25478714 BACKGROUND

• 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.

  PMID: 28301358 BACKGROUND

• Calvert JW, Cahill J, Zhang JH. Hyperbaric oxygen and cerebral physiology. Neurol Res. 2007 Mar;29(2):132-41. doi: 10.1179/016164107X174156.

  PMID: 17439697 BACKGROUND

• 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.

  PMID: 22703610 BACKGROUND

• LeClerc S, Easley D. Pharmacological therapies for autism spectrum disorder: a review. P T. 2015 Jun;40(6):389-97.

  PMID: 26045648 BACKGROUND

• 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.

  PMID: 10956571 BACKGROUND

• 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.

  PMID: 21818676 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Interventions

Risperidone; Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Usama Aly, PhD

  Minia University

  STUDY CHAIR

• Khaled Khaled, Prof.

  Minia University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: Children were divided into four groups.Twenty autistic children in each group. They followed up for 2 years.

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 25, 2019
• Study Start: January 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 25, 2019

Record last verified: 2019-03