Mechanism Study of Sulforaphane in ASD Improvement

NCT07047976 | Withdrawn

• 1 other identifier: LYG20240055
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to find out if sulforaphane (SFN) can improve social skills and behavior in people with Autism Spectrum Disorder (ASD). ASD is a developmental disorder that affects how children and teenagers interact with others. The number of people diagnosed with ASD has been rising, putting a lot of pressure on families and society. The investigators hope this study will lead to new treatments. The main questions the investigators want to answer are: Can sulforaphane help improve social communication in people with ASD? How does sulforaphane affect the balance of certain chemicals in the brain? The investigators will recruit 50 participants aged 12 to 34 diagnosed with ASD and 30 healthy volunteers for comparison. Participants will: Take 3 capsules of sulforaphane each day for 8 weeks. Complete regular psychological tests, undergo brain scans, and have their brain activity monitored to assess the treatment's effectiveness. Through this study, the investigators aim to discover the potential benefits of sulforaphane for individuals with ASD and provide new insights for future treatment options.

Conditions

Autism Spectrum Disorder; Sulforaphane

Outcome Measures

Primary Outcomes (2)

• Social communication changes index

  Assessed by the Social Response Scale (SRS-II). This scale is used to evaluate the severity of social symptoms associated with autism spectrum disorders and includes five subdimensions: social awareness, social cognition, social communication, social motivation, and autism behaviors. The change in social communication scores from baseline to the end of the study period will be the primary outcome of interest. The critical value is 59.5, and the total score is the sum of all entries, with the lowest score of 0 and the highest score of 3 for each entry. The total score of this scale represents the severity of social functioning impairments in the participants, with higher scores indicating greater severity.

  At baseline, week 4, and week 8

• Autism assessment index

  Autism was assessed using the Oregon State University Autism Rating Scale, DSM-5 (OARS-5), which includes the signs and symptoms of autism spectrum disorders described in the DSM-5. The scores include :1; Total number of symptoms. Every symptom that occurs (i.e., 1, 2, or 3 points) is recorded in the symptom count. 2. Weighted average severity. The clinician scored each item on a scale of 0, 1, 2 or 3 based on the parent's description of the particular problem. 3. Damage index. In Section C of OARS-5, after discussion with the child/adolescent's caregiver, the clinician will rate the level of support on a scale of 0(no support) to 3(maximum support). In the OARS-5 scale, higher scores indicate more severe symptoms.

  At baseline, week 4, and week 8

Secondary Outcomes (25)

• Functional E/I Ratio in EEG

  At baseline, week 4, and week 8

• Concentration Ratios of Neurotransmitters in Magnetic Resonance Spectroscopy

  At baseline, week 4, and week 8

• Eye Movement Parameters During Cognitive Tasks

  At baseline, week 4, and week 8

• Performance on the 'Reading the Mind in the Eyes' Test

  At baseline, week 4, and week 8

• Score on the Frith-Happe Animations Task

  At baseline, week 4, and week 8

Other Outcomes (2)

• Plasma metabolite levels assessment

  At baseline, week 4, and week 8

• Safety evaluation SAFTEE indicator

  At baseline, week 4, and week 8

Study Arms (1)

Sulforaphane Intervention Group for Autism Spectrum Disorder

EXPERIMENTAL

Dietary Supplement: Sulforaphane

Interventions

Sulforaphane DIETARY_SUPPLEMENT

This intervention involves the administration of Sulforaphane, a compound derived from glucoraphanin found in cruciferous vegetables. Participants will receive Avmacol® tablets, each containing 30 mg of glucoraphanin (approximately 68 μmol per tablet). They will take 3 tablets daily, resulting in a total daily dosage of approximately 90 μmol of Sulforaphane. The intervention will last for 8 weeks, during which participants will be monitored for clinical and biological outcomes.

Sulforaphane Intervention Group for Autism Spectrum Disorder

Eligibility Criteria

• Age: 12 Years - 34 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age between 12-34 years.
• Diagnosis of Autism Spectrum Disorder (ASD) as per the DSM-V criteria.
• Diagnosis of ASD according to the Autism Diagnostic Interview-Revised (ADI-R).
• Diagnosis of ASD based on the Autism Diagnostic Observation Schedule (ADOS).

You may not qualify if:

• a. Presence of severe physical illnesses or conditions, such as:
• Congenital heart disease
• Thyroid disorders
• Liver or kidney dysfunction
• Visual or hearing impairments b. Severe neurological diseases with a clear family history or potential risk factors, such as:
• a)Traumatic brain injury b) Encephalitis c) Epilepsy d) High fever seizures e) Birth trauma f） Abnormal EEG c. Known or suspected genetic disorders, such as:
• Down syndrome
• Fragile X syndrome d. Diagnosis of other developmental disorders, such as:
• a) Isolated intellectual disability b) Isolated language development disorder c) Selective mutism e. Diagnosis of other major psychiatric disorders, such as:
• Schizophrenia
• Bipolar disorder f. Currently taking other psychiatric or neurological medications.
• Age between 12-34 years.
• No diagnosis of any mental disorders.

Sponsors & Collaborators

• Jian-Jun Ou: lead

Study Sites (1)

Department of Psychiatry, Xiangya Second Hospital, Central South University

Changsha, Hunan, 410000, China

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

sulforaphane

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Jianjun Ou, Doctor

  Central South University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: July 2, 2025
• Study Start: September 20, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: September 4, 2025

Record last verified: 2024-09

Locations

CN (1)