A Study on the Mechanisms of Sulforaphane in Improving Autism Spectrum Disorder
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Social communication changes index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 34 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for ASD Group:
- •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).
排除标准
- •for ASD Group:
- •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.
- •Inclusion Criteria for Healthy Control Group:
- •Age between 12-34 years.
- •No diagnosis of any mental disorders.
- •Exclusion Criteria for Healthy Control Group:Exclusion criteria are the same as those for the ASD group.
结局指标
主要结局
Social communication changes index
时间窗: At baseline, week 4, and week 8
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.
Autism assessment index
时间窗: At baseline, week 4, and week 8
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.
Social communication changes index
时间窗: At baseline, week 4, and week 8
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.
Autism assessment index
时间窗: At baseline, week 4, and week 8
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.
次要结局
- Performance on the 'Reading the Mind in the Eyes' Test(At baseline, week 4, and week 8)
- 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)
- Adult executive functioning assessment index(At baseline, week 4, and week 8)
- Cross-Cutting symptom assessment index(At baseline, week 4, and week 8)
- Borderline symptom severity index(At baseline, week 4, and week 8)
- Autism spectrum traits assessment index(At baseline, week 4, and week 8)
- Adult Self-Report (ASR) psychopathology index(At baseline, week 4, and week 8)
- Eye Movement Parameters During Cognitive Tasks(At baseline, week 4, and week 8)
- Score on the Frith-Happe Animations Task(At baseline, week 4, and week 8)
- Assessment of treatment outcomes in autism spectrum disorder(At baseline, week 4, and week 8)
- Adult ADHD symptom assessment index(At baseline, week 4, and week 8)
- Depressive symptoms assessment index(At baseline, week 4, and week 8)
- Score on the Strange Stories Task(At baseline, week 4, and week 8)
- Camouflaging behavior assessment index(At baseline, week 4, and week 8)
- Behavioral inhibition and activation systems index(At baseline, week 4, and week 8)
- Clinical global impression assessment index(At baseline, week 4, and week 8)
- Systemizing cognitive style index(At baseline, week 4, and week 8)
- Anxiety symptoms assessment index(At baseline, week 4, and week 8)
- Manic symptoms assessment index(At baseline, week 4, and week 8)
- Empathy differentiation index(At baseline, week 4, and week 8)
- Callous-Unemotional traits assessment index(At baseline, week 4, and week 8)
- Athens insomnia evaluation index(At baseline, week 4, and week 8)
- Empathic ability assessment index(At baseline, week 4, and week 8)
- Sensory sensitivity assessment scale(At baseline, week 4, and week 8)
- 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)
- Score on the Strange Stories Task(At baseline, week 4, and week 8)
- Clinical global impression assessment index(At baseline, week 4, and week 8)
- Assessment of treatment outcomes in autism spectrum disorder(At baseline, week 4, and week 8)
- Adult ADHD symptom assessment index(At baseline, week 4, and week 8)
- Adult executive functioning assessment index(At baseline, week 4, and week 8)
- Depressive symptoms assessment index(At baseline, week 4, and week 8)
- Manic symptoms assessment index(At baseline, week 4, and week 8)
- Cross-Cutting symptom assessment index(At baseline, week 4, and week 8)
- Camouflaging behavior assessment index(At baseline, week 4, and week 8)
- Borderline symptom severity index(At baseline, week 4, and week 8)
- Empathy differentiation index(At baseline, week 4, and week 8)
- Callous-Unemotional traits assessment index(At baseline, week 4, and week 8)
- Athens insomnia evaluation index(At baseline, week 4, and week 8)
- Autism spectrum traits assessment index(At baseline, week 4, and week 8)
- Empathic ability assessment index(At baseline, week 4, and week 8)
- Systemizing cognitive style index(At baseline, week 4, and week 8)
- Sensory sensitivity assessment scale(At baseline, week 4, and week 8)
- Behavioral inhibition and activation systems index(At baseline, week 4, and week 8)
- Adult Self-Report (ASR) psychopathology index(At baseline, week 4, and week 8)
研究者
Jian-Jun Ou
Principal investigator
Central South University