Phase 2 Randomized Placebo-controlled, Double-blind, Parallel Study to Assess the Safety and Efficacy of an Oral Marijuana-Based Investigational Medical Product to Treat Anxiety in Adults With Autism Spectrum Disorder (ASD)

The goal of this clinical trial is to learn if drug ABC works to treat severe asthma in adults. It will also learn about the safety of drug ABC. The main questions it aims to answer are:
Will a marijuana-based drug help anxiety in autistic adults?
Anxiety can make socializing and working more difficult for people. Researchers will compare a marijuana based drug (that is mostly CBD with a small amount of THC) to a placebo (a look-alike substance that contains no drug) to see if the drug makes symptoms of anxiety better.
Participants will take the drug (or a placebo) every day for 8 weeks and keep a diary to record the time they took the drug, and their feelings each day. The drug is taken orally in drops once or twice a day. The study staff will speak to the participants weekly either over the phone or in the clinic. Clinic visits once every 2 weeks for checkups and tests. The researchers will make sure participants are healthy and see if there are any changes in anxiety.

开始日期2024-10-01

申办/合作机构

Southwest Autism Research & Resource Center

NCT06577623 / RecruitingN/AIIT

In-Person Mindfulness-based Intervention for Adolescents with Autism Spectrum Disorder and Their Caregivers

Adolescents with ASD often have co-occurring mental health symptoms like stress, anxiety, and depression. The investigators are conducting this research study to develop interventions for adolescents with ASD that will improve co-occurring mental health symptoms.

开始日期2024-08-14

申办/合作机构

Southwest Autism Research & Resource Center

NCT04322734 / Not yet recruitingN/AIIT

Transgenerational Metabolic-Immune Biomarkers of Neurological and Neurodevelopmental Disorders

Researchers in the Neurodevelopmental Division at Phoenix Children's Hospital are conducting a study about mitochondrial function in children with autism spectrum disorder (ASD). The study involves up to 5 visits to Phoenix Children's Hospital with fasting blood draws, behavioral assessments, and/or questionnaires. Other samples may be collected when appropriate.
This study is currently recruiting.
There is no cost for visits or study-related exams.

开始日期2024-07-01

申办/合作机构

Southwest Autism Research & Resource Center

[+1]

100 项与 Southwest Autism Research & Resource Center 相关的临床结果

登录后查看更多信息

0 项与 Southwest Autism Research & Resource Center 相关的专利（医药）

登录后查看更多信息

项与 Southwest Autism Research & Resource Center 相关的文献（医药）

2024-11-01·Journal of Autism and Developmental Disorders

Validation of an Enhanced Telehealth Platform for Toddlers at Increased Likelihood for a Diagnosis of Autism Spectrum Disorder (ASD)

Article

作者: Lord, Catherine ; Krishnan, Ashwin V ; Rice, Catherine E ; Kassem, Sara ; Oberleitner, Ron ; Platner, Amanda ; Ousley, Opal Y ; Smith, Christopher J ; Schwartz, Allison J ; Morrier, Michael J

Use of telehealth assessments for toddlers at increased likelihood of autism spectrum disorder (ASD) began prior to the global COVID-19 pandemic; however, the value of telehealth assessments as an alternative to in-person assessment (IPA) became clearer during the pandemic. The Naturalistic Observation Diagnosis Assessment (NODA™), previously demonstrated as a valid and reliable tool to evaluate asynchronous behaviors for early diagnosis, was enhanced to add synchronous collection of behaviors to assist clinicians in making a differential diagnosis of ASD. This study was conducted to validate the information gathered through NODA-Enhanced (NODA-E™) as compared to a gold standard IPA. Forty-nine toddlers aged 16.0-32.1 months of age, recruited through community pediatric offices and a tertiary ASD clinic, participated in both NODA-E and IPA assessments. There was high agreement between the two assessment protocols for overall diagnosis (46 of 49 cases; 93.6%; κ = .878), specific diagnostic criteria for social communication and social interaction (SCI; range 95.9-98%; κ = .918-.959), and for two of four criteria specified for restricted and repetitive behaviors (RRB; range 87.8-98%; κ = .755 and .959). There was lower agreement for two subcategories of RRBs (range 65.3-67.3%; κ = .306 and .347). NODA-E is a tool that can assist clinicians in making reliable and valid early ASD diagnoses using both asynchronous and synchronous information gathered via telehealth and offers an additional tool within a clinician's assessment toolbox.

2024-07-01·Neurobiology of Disease

Biomarkers of mitochondrial dysfunction in autism spectrum disorder: A systematic review and meta-analysis

Review

作者: Rincon, Nicole ; Frye, Richard E ; Scheck, Adrienne C ; Rossignol, Daniel A ; McCarty, Patrick J ; Brister, Danielle

Autism spectrum disorder (ASD) is a neurodevelopmental disorder affecting 1 in 36 children and is associated with physiological abnormalities, most notably mitochondrial dysfunction, at least in a subset of individuals. This systematic review and meta-analysis discovered 204 relevant articles which evaluated biomarkers of mitochondrial dysfunction in ASD individuals. Significant elevations (all p < 0.01) in the prevalence of lactate (17%), pyruvate (41%), alanine (15%) and creatine kinase (9%) were found in ASD. Individuals with ASD had significant differences (all p < 0.01) with moderate to large effect sizes (Cohen's d' ≥ 0.6) compared to controls in mean pyruvate, lactate-to-pyruvate ratio, ATP, and creatine kinase. Some studies found abnormal TCA cycle metabolites associated with ASD. Thirteen controlled studies reported mitochondrial DNA (mtDNA) deletions or variations in the ASD group in blood, peripheral blood mononuclear cells, lymphocytes, leucocytes, granulocytes, and brain. Meta-analyses discovered significant differences (p < 0.01) in copy number of mtDNA overall and in ND1, ND4 and CytB genes. Four studies linked specific mtDNA haplogroups to ASD. A series of studies found a subgroup of ASD with elevated mitochondrial respiration which was associated with increased sensitivity of the mitochondria to physiological stressors and neurodevelopmental regression. Lactate, pyruvate, lactate-to-pyruvate ratio, carnitine, and acyl-carnitines were associated with clinical features such as delays in language, social interaction, cognition, motor skills, and with repetitive behaviors and gastrointestinal symptoms, although not all studies found an association. Lactate, carnitine, acyl-carnitines, ATP, CoQ10, as well as mtDNA variants, heteroplasmy, haplogroups and copy number were associated with ASD severity. Variability was found across biomarker studies primarily due to differences in collection and processing techniques as well as the intrinsic heterogeneity of the ASD population. Several studies reported alterations in mitochondrial metabolism in mothers of children with ASD and in neonates who develop ASD. Treatments targeting mitochondria, particularly carnitine and ubiquinol, appear beneficial in ASD. The link between mitochondrial dysfunction in ASD and common physiological abnormalities in individuals with ASD including gastrointestinal disorders, oxidative stress, and immune dysfunction is outlined. Several subtypes of mitochondrial dysfunction in ASD are discussed, including one related to neurodevelopmental regression, another related to alterations in microbiome metabolites, and another related to elevations in acyl-carnitines. Mechanisms linking abnormal mitochondrial function with alterations in prenatal brain development and postnatal brain function are outlined. Given the multisystem complexity of some individuals with ASD, this review presents evidence for the mitochondria being central to ASD by contributing to abnormalities in brain development, cognition, and comorbidities such as immune and gastrointestinal dysfunction as well as neurodevelopmental regression. A diagnostic approach to identify mitochondrial dysfunction in ASD is outlined. From this evidence, it is clear that many individuals with ASD have alterations in mitochondrial function which may need to be addressed in order to achieve optimal clinical outcomes. The fact that alterations in mitochondrial metabolism may be found during pregnancy and early in the life of individuals who eventually develop ASD provides promise for early life predictive biomarkers of ASD. Further studies may improve the understanding of the role of the mitochondria in ASD by better defining subgroups and understanding the molecular mechanisms driving some of the unique changes found in mitochondrial function in those with ASD.

2024-06-01·Journal of Autism and Developmental Disorders

Examination of Clinical and Assessment Type Differences Between Toddlers with ASD from Multiplex and Simplex Families

Article

作者: Matthews, Nicole ; Ariff, Afzal ; Anbar, Joshua ; Smith, Christopher J ; Pierce, Karen ; James, Stephen

Few studies have examined differences in autism spectrum disorder (ASD) phenotype between children from multiplex and simplex families at the time of diagnosis. The present study used an age- and gender-matched, community-based sample (n = 105) from the southwestern United States to examine differences in ASD symptom severity, cognitive development, and adaptive functioning. No significant differences between children from multiplex and simplex families were observed. Exploratory analysis revealed that parents underreported receptive and expressive language and fine motor skills compared to professional observation, especially among children from multiplex families. These findings suggest that diagnosticians may need to consider family structure when choosing and interpreting assessments of receptive language, expressive language, and fine motor skills.

100 项与 Southwest Autism Research & Resource Center 相关的药物交易

登录后查看更多信息

100 项与 Southwest Autism Research & Resource Center 相关的转化医学

登录后查看更多信息