Mechanism Study of Sulforaphane in ASD Improvement

NCT ID: NCT07047976

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-20
• Study Completion Date: 2026-07-01

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.

Detailed Description

This study aims to investigate the mechanisms by which sulforaphane (SFN) ameliorates the excitatory/inhibitory imbalance in patients with Autism Spectrum Disorder (ASD). ASD is a pervasive developmental disorder characterized by impairments in social communication, interaction, and stereotyped behaviors. In recent years, the prevalence of ASD has been rising, imposing a significant burden on families and society. Although current primary interventions focus on educational training, there is a lack of effective biological treatments. Preliminary studies have demonstrated that sulforaphane can safely and effectively improve core clinical symptoms in Chinese patients with ASD, showing significant associations with metabolites related to excitatory/inhibitory balance, such as taurine and phosphatidylserine.

This open-label study will recruit 50 ASD patients aged 12-34 years and 30 healthy controls for an 8-week clinical trial. The study will employ psychological and behavioral assessments, electroencephalography (EEG), and magnetic resonance imaging (MRI) to comprehensively evaluate changes in clinical phenotype and neurotransmitter levels in ASD patients. The primary outcome measure will be improvements in social communication, while secondary measures will include changes in other clinical symptoms and neurophysiological characteristics.

Through this study, the investigators aim to gain a deeper understanding of the effects of sulforaphane on ASD patients, providing a new theoretical foundation and clinical evidence for the precise treatment of ASD.

Conditions

Autism Spectrum Disorder; Sulforaphane

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sulforaphane Intervention Group for Autism Spectrum Disorder

Group Type: EXPERIMENTAL

Sulforaphane

Intervention Type: 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.

Interventions

Sulforaphane

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Age between 12-34 years.

2. Diagnosis of Autism Spectrum Disorder (ASD) as per the DSM-V criteria.

3. Diagnosis of ASD according to the Autism Diagnostic Interview-Revised (ADI-R).

4. Diagnosis of ASD based on the Autism Diagnostic Observation Schedule (ADOS).

1. Age between 12-34 years.

2. No diagnosis of any mental disorders.

Exclusion Criteria

a. Presence of severe physical illnesses or conditions, such as:

1. Congenital heart disease

2. Thyroid disorders

3. Liver or kidney dysfunction

4. 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:

1. Down syndrome

2. 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:

1. Schizophrenia

2. Bipolar disorder f. Currently taking other psychiatric or neurological medications.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 34 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jian-Jun Ou

OTHER

Sponsor Role: lead

Responsible Party

Jian-Jun Ou

Principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jianjun Ou, Doctor

Role: STUDY_CHAIR

Central South University

Locations

Department of Psychiatry, Xiangya Second Hospital, Central South University

Changsha, Hunan, China

Countries

China

Other Identifiers

LYG20240055

Identifier Type: -

Identifier Source: org_study_id