Active clinical trials for "Autism Spectrum Disorder"

This study, Physical Exercise and Contributors to Academic Performance among Adolescents with Autism Spectrum Disorders (ASD), aims to expand our understanding of the impact of regular physical exercise on improvement in academic performance. The investigators will focus on the use of affordable, portable, and achievable interventions that can be easily shared and incorporated into other academic and home settings. The study will examine the use a regular vigorous exercise program for helping students with ASD reduce body mass index and improve executive function, motor performance, sensory responsiveness, and mood. The investigators propose a collaborative arrangement with an area school to conduct an 18-month exploratory pilot study of 30 middle- and high-school aged students (12 to 18 years old) with ASD, who are returning participants or are new to participating in the Fit Club at Gateway Academy. The investigators expect that the changes elicited by participation in this type of exercise program will support the formation of adult life skills, impacting on long-term quality of life for individuals with ASD and children with other conditions.

This study is an 8-week open-label trial testing oxytocin nasal spray (Syntocinon) as a treatment for social impairment in adolescents with autism spectrum disorders (ASD). We hypothesize that oxytocin nasal spray will be safe, tolerable, and effective in improving the core symptoms of autism spectrum disorders in adolescents ages 11-17.

Background. Increasing evidence indicates that brain inflammation is important in the pathogenesis of neuropsychiatric disorders, including at least a significant proportion of subjects with Autism spectrum disorder (ASD). Natural flavonoids, such as luteolin and quercetin, exhibit potent antioxidant and anti-inflammatory activities, inhibit the release of inflammatory mediators from human mast cells, and reduce maternal interleukin 6-induced autism-like behavioral deficits related to social interactions in mice. In a case series of 37 children with ASD who took a dietary supplement containing luteolin and quercetin for 4 months reported gains in eye contact, attention and social interaction according to parental reports. Aim. The purpose of this study was to assess the effectiveness and tolerability in white children with ASD of a dietary supplement containing 2 flavonoids, luteolin and quercetin, and the quercetin glycoside rutin. Methods. Fifty children (42 boys and 8 girls) divided into 2 equal age groups (4-6 years old, and 7-10 years) with ASD were enrolled in a 26-week, prospective, open-label trial at the 2nd University Department of Psychiatry at "Attikon" General Hospital, Athens, Greece, the Ethics Committee of which approved the study. The parents of all subjects were informed of the study's aims, including risks versus benefits of participating and not participating as well as the inclusion and exclusion criteria, and they written consent for participation in the study. Participants had already been diagnosed with ASD based on clinical assessments, and this diagnosis was corroborated at the 'Attikon' clinic by meeting the cutoff scores on both the DSM-IV-TR, symptom list and the ADOS algorithm. All children were medication naive. Apart from the diagnostic evaluation, the assessment also included a thorough medical evaluation comprising a physical examination and health history (including a review of allergic and gastrointestinal symptoms, as well as any food allergies or food intolerance). All concurrent interventions were thoroughly noted (type and hours), and the same was done at all visits. After meeting screening criteria, subjects were evaluated at the baseline visit, mid-trial visit at 18 weeks, and final visit at 26 weeks. Children were administered a dietary formulation containing 2 flavonoids, luteolin (100 mg/capsule) and quercetin (70 mg/capsule), and the quercetin glycoside rutin (30 mg/capsule). The dose used was 1 softgel capsule per 10 kg (22 lb) weight per day with food for 26 weeks. The primary outcomes were the age-equivalent scores in the 3 domains of the Vineland Adaptive Behavior Scales (VABS), communication, daily living skills, and socialization. The VABS was chosen because the impact of an agent on adaptive functioning in real life is even more important for obtaining a better quality of life than just alleviation of some symptoms. The raw scores from the interview can be also expressed as an age-equivalent score and a standard score compared with those of the subject's peers. There are also supplementary special norms for individuals with autism. Although standard scores could be more useful in subject characterization, their use as an outcome measure has been proven to be less sensitive due to floor effects and reduced variability, especially in short time periods, and thus these scores underestimate change. Conversely, scores of special norms tend to overestimate change, as a small increase in a raw score can produce a big improvement in special norm percentile rank. Thus, raw scores and age-equivalent scores seem to be the most appropriate for use as outcome measures, with the latter being more easily interpreted as change over time. Secondary outcomes included the Aberrant Behavior Checklist (ABC), the Autism Treatment Evaluation Checklist (ATEC), and the Clinical Global Impression-Improvement score (CGI-I). To explore other possible effects of the formulation not captured from the aforementioned instruments, we chose to record any other benefits observed and reported by the parents during its use. For this, the primary clinician (K.F.) conducted telephone or in-person interviews of the parents, independently of the assessing clinician (A.T.), to discuss the possible gains of the child. CGI-I was also independently coded by the primary clinician with personal assessments as well as with information gathered by parents and, in the majority of cases, by the subjects' trainers. Compliance was monitored by softgel capsule count and the parents' assurance that the capsules had actually been taken at each visit; in case of a capsule count <85% of the prescribed dosage at midterm and at the end of the study, the subject was excluded from the final analysis. Adverse events were systematically recorded on an adverse event form by using scales indicating severity, relationship to the study procedures, action taken, and any therapy required.

Researchers at the Stanford University School of Medicine are seeking participants for a study examining the effectiveness of vasopressin, a neuropeptide, in treating children with autism spectrum disorder. Difficulty with social interactions is characteristic of people with autism, who often have problems interpreting facial expressions or maintaining eye contact while talking with someone. There are currently no effective medicines available to treat social problems in individuals with autism. Neuropeptides, such as vasopressin and oxytocin, are molecules used by neurons in the brain to communicate with one another. Vasopressin is closely related to oxytocin, which is currently being tested as a treatment for autism, and has been shown to enhance social functioning in animals. Animal studies have shown that when the proper functioning of vasopressin is experimentally altered, animals develop a variety of social deficits, including impaired memory for peers and a reduced interest in social interaction. Researchers found that when vasopressin was administered to mice with a genetically induced form of autism, their social functioning improved. Vasopressin is already approved by the Food and Drug Administration for use in humans, and has proved to be a successful treatment for some common pediatric conditions, including bedwetting. Similar to oxytocin, it also has been shown to improve social cognition and memory in people who do not have autism. The researchers will test the effects of vasopressin on social impairments in 50 boys and girls with autism, ages 6 to 12 years old. The study will last four weeks for each participant. Participants will receive either vasopressin or a placebo nasal spray. At the end of this phase of the study, those who received the placebo will have the option of participating in a four-week trial during which they will be given vasopressin. Stanford is the only site for the study. Participants do not need to live locally but will need to come to the Stanford University Department of Psychiatry and Behavioral Sciences for study visits.

In this protocol we aim to use rTMS to better characterize STS role in normal and abnormal social cognition. With that purpose, we will measure the effect of inhibitory and excitatory rTMS on the fixation time on social scenes (using eye-tracking methodology) or on the ability to recognize human voice/sounds.

Autism Spectrum Disorder (ASD) is a developmental disorder characterized by abnormalities in speech and communication, impaired social functioning and repetitive behaviors and restricted interests. Oxytocin (OT) is peptide that is known for its peripheral effects on facilitating uterine contractions and milk let-down; however, studies, mainly with rodents and non-human primates, has found that OT is involved in affiliative behaviors, including sexual behavior, mother-infant and adult-adult pair-bond formation, separation distress, and other aspects of social attachment. Moreover, OT is known to play an important role in repetitive behaviors and stress reactivity. Given that repetitive behaviors and deficits in social interaction are core symptom domains of autism, and that OT is involved in the regulation of repetitive and affiliative behaviors, it is believed that OT may play a role in the etiology of autism. Moreover, preliminary data obtained by Hollander and colleagues suggests that OT may be of value in treating core autism symptoms. Specifically, synthetic oxytocin administered via intravenous infusion to adults with autism spectrum disorders (ASD) produced significant reductions in repetitive behaviors and facilitated social cognition/memory in a double-blind, placebo-controlled cross-over laboratory challenge. Encouraged by these findings, the primary aim of this study is to investigate the safety and therapeutic efficacy of intranasal OT in treating repetitive behaviors and social functioning/cognitive deficits in adults with ASD. This research embraces a translational approach to develop a novel treatment for core ASD symptoms; given that there are currently no Food and Drug Administration (FDA) approved medication treatments for core ASD symptoms, this research addresses an important unmet need in the field. The goal of this study is to evaluate the safety and efficacy of repeated Intranasal Oxytocin Treatment (INOT)administration in adults with ASD.

Fragile X syndrome (FXS) is the most common inherited form of developmental disability. FXS is inherited from the carrier parent, most often the mothers. FXS is associated with severe interfering behavioral symptoms which include anxiety related symptoms, attention deficit hyperactivity, and aggressive behaviors. Approximately 25-33% of individuals with FXS also meet criteria for autistic disorder. The hypothesis of this study is that treatment with acamprosate will reduce inattention/hyperactivity, language impairment, irritability, social deficits, and cognitive delay in youth with FXS. The purpose of this study is to investigate the effectiveness and tolerability of acamprosate in youth with Fragile X Syndrome and to assess the potential psychophysiological differences between FXS and autism spectrum disorders.

The proposed study is an internet-based, randomized, double-blind, placebo-controlled trial which will assess changes in hyperactivity in children ages five through eight with an autism spectrum disorders (ASD) and elevated levels of hyperactivity. In order to answer this question, this study will assess changes in hyperactivity as measured by the Aberrant Behavior Checklist (ABC) in children with ASD and elevated baseline levels of hyperactivity who are randomly assigned to use 1.3 grams of omega-3 fatty acids daily compared to placebo. The overwhelming majority of study procedures, including recruitment, informed consent, assessment of inclusion and exclusion criteria, and collection of baseline and outcome measures will take place over the internet.

The purpose of this study is to determine if adults with autism spectrum disorder and with normal intelligence improve from 36 sessions (1 calendar year) of group treatment with Cognitive Behavioural Therapy or recreational activity in groups with 6-8 participants.

The purpose of this study is examine emotional regulation and reflective functioning in parents of children with Autism Spectrum Disorders (ASD) before and after an educational training (four sessions of group workshops). Our experimental aims are the following: 1) examine parental emotion regulation and reflective functioning in daily life, 2) examine child emotion regulation in their daily life 3)Learn about the training efficacy for ASD parents. This research study will help to formulate innovative treatment methods to reinforce positive emotion regulation and reflective functioning in both ASD children and their parents.