Double-blind Randomized Placebo-controlled Trail
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ashiya University
- Enrollment
- 13
- Primary Endpoint
- Aberrant Behavior Checklist-community (ABC)
Study Overview
Brief Summary
In a double-blind, placebo-controlled 16-week trial investigators administered daily doses of either youths with autism spectrum disorders.ARA and DHA supplementation significantly improved communication as well as social withdrawal symptoms. This pilot study provides the first evidence that supplementation with larger ARA doses added to DHA improve impaired social interaction in youths with Autism Spectrum Disorders (ASD).
Detailed Description
We recruited 13 individuals who met the DSM-IV criteria for a diagnosis of high functioning autistic disorder (n=1) or Asperger's Disorder (n=12),corroborated by the Autism Diagnostic Interview-Revised. Participants were free of any medical or comorbid psychiatric disorders. Other inclusion criteria included weigh of at least 16 kg, either a verbal or performance intelligence quotient (IQ) above 80, and a score greater than 10 on the social withdrawal subscale of the Aberrant Behavior Checklist-Community.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 6 Years to 29 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical diagnosis of high functioning autistic disorder or Asperger's Disorder. Free of any medical or comorbid psychiatric disorders.
Exclusion Criteria
- •Any medical treatment for other psychiatric disorders
Outcomes
Primary Outcomes
Aberrant Behavior Checklist-community (ABC)
Time Frame: Pretreatment and at 4 weeks after intervention for 16-weeks trial
ABC is used to estimate abnormal behavior, including 5 subscales, irritability, social withdrawal, stereotypy, hyperactivity, and inappropriate speech
Secondary Outcomes
- Social Responsiveness Scale (SRS)(pretreatment and at 4 weeks after intervention for 16-weeks trial)