Active clinical trials for "Autistic Disorder"

Autism Spectrum Disorder (ASD) refers to a group of neurodevelopmental disorders including autism.Despite ongoing studies, the pathogenesis of ASD still remains unclear.The global prevalence of ASD was estimated at 1% in 2015.The diagnostic criteria for ASD are specified in the DSM ( American Psychiatric Association, 2013 ) and serve as guideline for clinicians at the present. However, its early diagnosis value is limited due to a high subjectivities and its low diagnostic sensitivity and specificity.Early detection and early pharmacological and behavioral interventions are critical in improving the symptoms and preventing the disease progression. There are no medications that directly treat the core symptoms present in individuals with ASD, and the effectiveness of interventions remains limited. Therefore, accurate assessment of pharmacological efficacy is necessary for the reatment, and prognostication of individuals with ASD. Magnetic resonance imaging (MRI) is a commonly used imaging tool for clinical disease diagnosis, especially for neurological disorders. Besides, Structural Magnetic Resonance imaging reflects neuropathological and microstructural developmental changes during growth. Radiomics based on the high-dimensional quantitation of medical images, allowing extraction of more detailed characteristics than is possible with conventional visual interpretation. This study aims: (1)To explore an objective diagnostic method through radiomics in children with ASD (2)to provide prognostic estimates of the outcome, based on estimates of an individual patient's prognosis and the efficacy of different drug therapies.

The goal of this research is to explore abilities to learn word meanings from overheard conversations in children with ASD (and, as a control, typically developing children). Specific Aim 2 (Experiment 2): Determine whether children with ASD can learn from addressed and overheard teaching via videoconferencing. The investigators will use a similar procedure to Study 1, except that both overheard and directed teaching will take place on video.

Background: - Some children with autism spectrum disorders (ASD) do not have normal sleep cycles. Some of these children spend very little time in the rapid eye movement (REM) stage of sleep. Some studies suggest that less time in REM sleep can be associated with learning and behavior problems. Donepezil is a medication used to treat Alzheimer s disease. Donepezil can increase REM sleep in some adults with different disorders. A small study showed that Donepezil can also increase REM sleep in children with ASD. Researchers now want to see if Donepezil can improve communication skills and social interaction in children with ASD. They also want to see if any change in symptoms seems to come from changes in REM sleep. Objectives: - To see if a medication, Donepezil, can improve the way communication skills and social interaction develop in young children with autism spectrum disorders. Eligibility: - Children 22 to 44 months of age with ASD. Design: Participants will be screened with a blood test, heart tests, and a sleep study. During the sleep study, children will sleep in a darkened room for 2 nights with electrodes on their body and a tube under their nose. Parents can sleep in the room with their child. A technician will monitor the room all night. Participants will take the study medication once a day. Treatment will be monitored at visits every 3 months. At each visit the participant will take blood tests, heart tests, or behavior tests. Participants will have 2 more sleep studies. Participation will end after 18 months.

This study is working towards gaining a better understanding of the genetic and environmental factors involved in autism spectrum disorders (ASD), which includes autism, pervasive developmental disorder (PDD), and Asperger's syndrome. The investigators hope that information gained from this study will lead to new ways of diagnosing and treating ASDs.

For participants enrolled prior to Version 6 of the protocol: This was a Phase II multi-center, randomized, double-blind, 24-week, 3-arm, parallel group, placebo-controlled study to investigate the efficacy, safety, and pharmacokinetics of balovaptan in children and adolescents aged 5-17 years with ASD who are high functioning (intelligence quotient [IQ] greater than or equal to [>=] 70). For participants enrolled according to Version 6 of the protocol: This was a Phase II multi-center, randomized, double-blind, 24-week, parallel group, placebo-controlled, 2-arm study with participants assigned either to a 10 milligram (mg) or equivalent dose of balovaptan, or placebo. All other study parameters remained as stated above. There are three parts to this study: PK Part (Study part 1) included up to 8 weeks of treatment, Main Treatment Part (Study part 2) included 24 week of treatment, and the Open Label Extension Part (Study part 3) included Week 24 to Week 76 of treatment. All participants that completed the 24-week treatment period were eligible to participate in an optional 52-week open-label extension (OLE) during which they received balovaptan treatment.

The clinical manifestation of autism spectrum disorder (ASD) is complex, with medical and mental health disruptions that occur with the three core behavioral criteria used for diagnosis (social behavior, communication, restricted interests/repetitive behavior). Co-occurring medical conditions, such as gastrointestinal dysfunction (GID), often are overlooked when designing research strategies to understand the mechanisms underlying the expression of ASD. This study was initially a collaboration between Children's Hospital Los Angeles (CHLA) and the Children's Hospital at Vanderbilt University. The current research project proposes to recruit subject at CHLA and the Center for Autism and Developmental Disorders (CAND), a Children's Hospital of Orange County and University of California Irvine (UCI) Health collaborative program. In Aim 1, the investigators will characterize GID in pediatric populations with ASD. Over a 12 month period, subjects will receive standard of care for their GID, typically functional constipation. The study population will be characterized with a standardized instrument for diagnosing functional GI disorders in children, the Questionnaire on Pediatric Gastrointestinal Symptoms, and with the clinical acumen of an experienced pediatric gastroenterologist. Nutritional information also will be collected to determine whether there are patterns of GIDs that correlate with dietary and nutritional status. The in-depth characterization and treatment of GIDs in children with ASD will provide a unique way of determining if ASD symptom and GID symptom improvement are related to each other. In Aim 2, the investigators will do in-depth assessment of each subjects functional status for social communication, emotional regulation, cognitive function, speech-language, sensory integration, and a biomarker of oxidative stress. The latter will be measured in urine samples over the course of one year. There are no direct interventions for autism symptoms in this study. Rather, subjects will receive standard of care for the GID diagnosis and secondary effects on ASD symptoms will be evaluated. Our power calculation shows that the investigators will be adequately powered with the proposed study design and recruitment targets. As part of the study, the investigators have developed a collaboration with investigators in the University of Southern California (USC) School of Engineering, in which the investigators will work with them to develop computational tools to assist in the characterization of videotaped Autism Diagnostic Observation Schedule (ADOS-2) assessments.

There are two phases to the study. The first will examine serum copper and zinc levels and copper/zinc ratio in children (ages 3-8) who have autism and compare them to levels from same sex and age children who are developing typically. The hypothesis is that there is a significant difference in the copper/zinc ratio between young children who have autism and their typically developing peers. The second phase of the study will evaluate the effect of dietary supplementation using zinc and vitamin C for 16 weeks on selected symptoms of autism. Children with autism will be enrolled on the basis of copper/zinc ratios greater than 2.0, and as determined to be statistically higher than typically developing children. Measurements of serum copper, zinc and unbound copper will be obtained prior to, at the mid-point and end of the trial. Those children whose ratios have not fallen below 1.25, the top of the currently recognized range will have the zinc and vitamin C doses adjusted for the duration of the trial. Detailed evaluation of language skills, and a variety of behaviors will be evaluated prior to and after supplementation. The study will be placebo-controlled and double blind. Those children enrolled in the placebo arm will be offered a full trial of supplements at the end of the their participation in the study. The hypothesis to be tested is whether correction of elevated copper to zinc ratios in children with autism can be accomplished by oral supplementation with zinc and vitamin C and if these children show measurable and significant changes in receptive or expressive language or behavioral parameters associated with autism.

The Early start Denver model (Rogers, 2010; Dawson, 2010) is a developmental and behavioral model that aim to enhance socio-comunicative abilities and also global development of children with Autism spectrum disorder (ASD). The purpose of this study is to identify changes in neurocognitive profile of children population with ASD receiving Early Start Denver Model (ESDM) applied 12 hours per week in comparison to children receiving other interventions. That is a study proposed to children with ASD and their families that participate already to a randomized control study called IDEA registered on clinicaltrials.gov NCT02608333. the investigators hypothesized that ESDM would increase social cognition, reduce shifting attention time and increase preference for unpredictable stimuli.

This study explores the effectiveness of chiropractic and neuromuscular reeducation as complementary and alternative medicine treatment approaches for autism. Our investigation maintains the following three hypotheses: Spinal manipulative therapy (SMT) will reduce the presentation of autistic symptoms in children. Spinal manipulative therapy (SMT) in conjunction with neuromuscular reeducation will reduce the presentation of autistic symptoms in children. The presentation of autistic symptoms in children will significantly differ between the treatment groups of spinal manipulative therapy and spinal manipulative therapy in unification with neuromuscular reeducation.

The major objective of this research protocol is to directly compare two parent intervention conditions of Early Social Interaction (ESI) for 9 months on developmental trajectories of infants showing early risk for Autism Spectrum Disorder (ASD). Participants will be randomized to receive an information, education and support group (Group) ESI intervention offered weekly, or a parent-implemented intervention (Individual) ESI intervention offered in twice-weekly, in combination with the Group ESI intervention.