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Intranasal Oxytocin Treatment for Social Deficits in Children With Autism
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Autism is a pervasive developmental disorder characterized by core deficits in social behavior and communication, and the presence of repetitive or stereotyped behaviors. It is one of three recognized disorders in the autism spectrum which affects an estimated 1 in 88 children in the United States. At present, pharmacotherapies target only associated features of autism, with no effective drug treatments for the social impairments. Several lines of evidence now suggest that the neuropeptide oxytocin (OT) may be an effective treatment for the core social deficits in autism. Here we will test the effects of twice daily intranasal OT (24 IU) over a 4-week period for enhancing social deficits in male and female children aged 6-12 years with autism. This research has high potential to lead to the development of more effective treatments and earlier interventions for children with autism.
Stanford is currently not accepting patients for this trial.
For more information, please contact Robin Libove, BS, (650) 736-1235.
Lead Sponsor
Stanford Investigators
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The Role of Vasopressin in the Social Deficits of Autism
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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.
Stanford is currently not accepting patients for this trial.
For more information, please contact Robin A Libove, BS, 650-736-1235.
Lead Sponsor
Stanford Investigators
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A Study of Pregnenolone in the Treatment of Individuals With Autism
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This study will assess the tolerability and effectiveness of pregnenolone in the treatment of behavioral deficits in adults with autism. Pregnenolone is a naturally occurring hormone found in the body which has been shown to help with the function of nerve cells. It is also shown to modulate the activity of certain brain receptors implicated in autism. We hope to examine the tolerability of pregnenolone in adults with autism.
Stanford is currently not accepting patients for this trial.
For more information, please contact Robin Libove, BS, 650-736-1235.
Lead Sponsor
Stanford Investigators
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Transcranial Magnetic Stimulation for Restricted and Repetitive Behavior in ASD
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Investigating the efficacy of a form of TMS called theta-burst stimulation for restricted and repetitive behavior in ASD.
Lead Sponsor
Stanford Investigators
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A Center Based Study of Pivotal Response Treatment for Preschoolers With Autism
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The purpose of this study is to examine the effectiveness of pivotal response training (PRT) in an intensive center-based environment to treat social communication deficits in children with autism spectrum disorder (ASD).
Lead Sponsor
Stanford Investigators
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An Open-Label Study of N-Acetyl Cysteine in Children With Autism
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The purpose of the study is to test the tolerability and efficacy of N-Acetyl Cysteine (NAC) in children with Autism.
Stanford is currently not accepting patients for this trial.
For more information, please contact Robin Libove, 6507361235.
Lead Sponsor
Stanford Investigators
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An Evaluation of a Developmentally-Based Parent Training Program for Children With Autism
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The purpose of this study is to assess the efficacy of a parent training program in the treatment of social and communication deficits in children with autism. Specifically, this study will evaluate a developmentally based parent delivered intervention in the community developed by Pacific Autism Center for Education (PACE).
Stanford is currently not accepting patients for this trial.
For more information, please contact Christina Ardel, MA, 650-736-1235.
Lead Sponsor
Stanford Investigators
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Trial of Zolpidem for Sleep in Children With Autism
Recruiting
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The purpose of this study is to examine the effect of zolpidem on sleep in children and adolescents with Autism Spectrum Disorder (ASD). Zolpidem is a nonbenzodiazepine GABAa receptor agonist drug that acts as a hypnotic. To accomplish this, the investigators will use a randomized double-blind placebo-controlled crossover 8-week study design to examine the effect of zolpidem on sleep physiology as assessed by polysomnography (PSG), actigraphy, circadian rhythm, and clinical measures.
Lead Sponsor
Stanford Investigators
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Natural History Study of Individuals With Autism and Germline Heterozygous PTEN Mutations
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The purpose of this study is to determine cross-sectional and longitudinal medical, behavioral, and cognitive differences between PTEN ASD and other groups, as well as to identify cognitive, neural systems, and molecular biomarkers specific to PTEN ASD. In addition, this study will be creating and maintaining a biorepository and linked phenotypic database for PTEN ASD.
Stanford Investigators
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Trial of Center-Based Vs. In-Home Pivotal Response Treatment (PRT) in Autism
Recruiting
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The aim of this clinical trial is to compare the efficacy of a 16-week center-based Pivotal Response Treatment (PRT-C) versus home-based Pivotal Response Treatment (PRT-H) in targeting social communication deficits in young children with autism spectrum disorder (ASD) with significant language delay. The two groups will also be compared to a control group that consists of children who are receiving treatment as usual (TAU).
Lead Sponsor
Stanford Investigators
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Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children With Autism
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Autism spectrum disorder (ASD) is a very heterogeneous disorder with limited empirically validated behavioral and biological interventions. The goal of this pilot investigation is to apply a biologically-based approach to identify predictors of treatment response in children with ASD who are receiving Pivotal Response Treatment (PRT), an evidence-based behavioral intervention. Specifically, the investigators propose to identify neuroimaging biomarkers of treatment response to a PRT program (PRT-P) targeting language deficits in young children with ASD who will be randomized to either PRT-P or to a delayed treatment group (DTG).
Lead Sponsor
Stanford Investigators
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Sleep Restriction Therapy (SRT) for Sleep Problems in Children With Autism
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The purpose of this open label trial is to examine the acceptability, tolerability, and feasibility and preliminary effectiveness of sleep restriction therapy for sleep problems in children with autism spectrum disorder (ASD). Treatment will be delivered via secure telemedicine platform and consist of parent-training in delivering the intervention.
Lead Sponsor
Stanford Investigators
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A Center Based Early Intervention Program for Preschoolers with Developmental Disorders
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The purpose of this study is to examine the effectiveness of a 12-week early intervention program that will include 12 weekly hours in an intensive center-based preschool environment or in the home to treat social communication deficits in children with developmental disorders. The study will include children with developmental disorders, such as Autism Spectrum Disorder, neurogenetic disorders, or intellectual disability.
Lead Sponsor
Stanford Investigators
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Trial of Suvorexant for Sleep in Children With Autism
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The purpose of this study is to examine the effect of suvorexant on sleep in children and adolescents with Autism Spectrum Disorder (ASD). Suvorexant is a selective, dual orexin receptor antagonist (DORA) used for the treatment of sleep onset difficulties and/or sleep maintenance. To accomplish this, the investigators will use a randomized double-blind placebo-controlled crossover 8-week study design to examine the effect of suvorexant on sleep physiology as assessed by polysomnography (PSG), actigraphy, circadian rhythm, and clinical measures.
Lead Sponsor
Stanford Investigators
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A Study of Esomeprazole in Children with Autism
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Autism is a pervasive developmental disorder characterized by core deficits in social behavior and communication and the presence of repetitive/stereotyped behaviors. The objective of the study is to evaluate the efficacy of Esomeprazole as a treatment for social communication deficits in children with Autism Spectrum Disorder (ASD). This prospective 12 week open-label study will invite 25 children with ASD between the ages of 2 and 6 years of age to participate.
Stanford is currently not accepting patients for this trial.
For more information, please contact Lakshmi Vrittamani, 650-736-1235.
Lead Sponsor
Stanford Investigators
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Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth
Recruiting
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The purpose of this open label trial is to examine the preliminary feasibility, acceptability, and effectiveness of a 12-week behavioral intervention program (1 hour/week) to treat insistence on sameness (e.g., difficulty tolerating changes in routine) in youth with autism spectrum disorder (ASD). Treatment will be delivered via secure telemedicine platform and consist of a combination of parent-training and parent-mediated intervention with the child.
Lead Sponsor
Stanford Investigators
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A Study of N-Acetyl Cysteine in Children With Autism
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The purpose of the study is to test the tolerability and efficacy of N-Acetyl Cysteine (NAC) in children with Autism. NAC is a compound that increases the levels of Glutathione, the body's main antioxidant. Glutathione is a compound in the blood that is part of a natural defense system (the antioxidant system). Anti-oxidants protect the body from damage caused by internal toxins called "free radicals." It is possible that children with Autism tend to have lower levels of glutathione, an important compound in our bodies that helps combat the effects of toxic free radicals.
We hope that by studying the antioxidant system in more detail, we will increase our understanding of the reasons why people develop Autism so that we can design better ways to treat individuals with this condition. This study is meant to test the safety tolerability of NAC and its effectiveness in the treatment of behavioral difficulties in children with autism. It will also examine the possible benefit of this agent in improving the core deficits in autism such as social deficits.
Stanford is currently not accepting patients for this trial.
For more information, please contact Robin Libove, 6507361235.
Lead Sponsor
Stanford Investigators
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Randomized Controlled Study of Donepezil in Fragile X Syndrome
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Fragile X syndrome (FraX) is the most common known heritable cause of human intellectual disability. Though recent research has revealed much about the genetic and neurobiological bases of FraX, knowledge about specific and effective treatments for affected individuals is lacking. Based on information from both human and animal studies, one cause of intellectual disability in FraX may be related to deficits in a particular brain neurotransmitter system (the "cholinergic" system). Thus, the investigators propose to use a specific medication, donepezil, to augment cholinergic system in adolescents affected by FraX. If found to be effective, the knowledge generated by this research may also be relevant to other developmental disorders that share common disease pathways with FraX.
Stanford is currently not accepting patients for this trial.
For more information, please contact Mai K Manchanda, AB, 650-704-9763.
Lead Sponsor
Stanford Investigators
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Intranasal Vasopressin Treatment in Children With Autism
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The purpose of this clinical trial is to investigate the effectiveness of vasopressin nasal spray for treating symptoms associated with autism. Vasopressin is a hormone that is produced naturally within the body and has been implicated in regulating social behaviors. It has been proposed that administration of the hormone may also help improve social functioning in individuals with autism.
Stanford is currently not accepting patients for this trial.
For more information, please contact Briana Hernandez, 650-736-1235.
Lead Sponsor
Stanford Investigators
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Pilot Trial of Pregnenolone in Autism
Recruiting
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This is a research study to examine the tolerability and effectiveness of pregnenolone in individuals with autism. Pregnenolone is a naturally occurring steroid hormone in the brain that has been implicated in treating various psychiatric conditions. The investigators hope to learn the effects and safety of using pregnenolone in reducing irritability and sensitivity to sensory differences and improving social communication in individuals with autism. The investigators hope by studying the effects of pregnenolone in more detail, the investigators can design better ways to treat individuals with autism.
Lead Sponsor
Stanford Investigators
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Study of Pharmacokinetics, Safety, Efficacy, and Tolerability of Memantine in Children With Autism
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The purpose of this study is to investigate the safety and efficacy of memantine extended release, as well as its extent of absorption in pediatric patients with autism.
Stanford is currently not accepting patients for this trial.
For more information, please contact Robin Libove, 6507361235.
Stanford Investigators
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Evaluating Parent Delivered Interventions for Children With Autism
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The investigators will assess the efficacy of parent delivered interventions in the treatment of social and communication deficits in children with autism. By collecting information about parent and child functioning before and after intervention, the investigators will be able to determine whether the intervention is effective in improving child social communication and reducing parent stress.
Stanford is currently not accepting patients for this trial.
For more information, please contact Robin Libove, BS, 650-736-1235.
Lead Sponsor
Stanford Investigators
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Parent-Mediated Intervention Targeting Insistence on Sameness for Autistic Children
Recruiting
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This study will examine the potential effectiveness of a virtually delivered parent-mediated intervention for insistence on sameness behaviors in autism and investigate 1) whether caregivers can learn to deliver the adapted Supportive Parenting for Anxious Childhood emotions (SPACE) intervention for IS via telehealth and 2) whether children will show greater improvement in IS behaviors.
Lead Sponsor
Stanford Investigators
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Pivotal Response Group Treatment for Parents of Young Children With Autism
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This is a research study examining the effectiveness of pivotal response treatment group (PRTG) in targeting language skills in young children with autism. Research has demonstrated that behavioral interventions, such as Pivotal Response Training (PRT), lead to improvements in the core symptoms of autism. The purpose of this study is to further examine the effectiveness of teaching pivotal response treatment to parents of children with autism in a group format. To determine the effectiveness of pivotal response training group (PRTG) it will be compared to another parent education group by conducting a randomized controlled 12-week trial.
Stanford is currently not accepting patients for this trial.
For more information, please contact Antonio Hardan, MD, .
Lead Sponsor
Stanford Investigators
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Trial of Diphenhydramine for Sleep in Children With Autism
Recruiting
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The purpose of this study is to examine the effect of diphenhydramine on sleep in children and adolescents with Autism Spectrum Disorder (ASD). Diphenhydramine is an anti-histaminergic agent with strong hypnotic properties. To accomplish this, the investigators will use a randomized double-blind placebo-controlled crossover 8-week study design to examine the effect of diphenhydramine on sleep physiology as assessed by polysomnography (PSG), actigraphy, circadian rhythm, and clinical measures.
Lead Sponsor
Stanford Investigators
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Pivotal Response Treatment for Individuals With Intellectual Disabilities
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The investigators will assess the efficacy of Pivotal Response Treatment (PRT) in the treatment of communication deficits in children with intellectual disabilities. By collecting information about parent and child functioning before and after PRT, The investigators will be able to determine whether the intervention is effective in improving child communication and reducing parent stress.
Stanford is currently not accepting patients for this trial.
For more information, please contact Rachel Schuck, MA, 650-736-1235.
Lead Sponsor
Stanford Investigators
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Pivotal Response Treatment Package for Young Children With Autism
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This is a research study examining the effectiveness of a pivotal response treatment package (PRT-P) in targeting language skills in young children with autism.
Stanford is currently not accepting patients for this trial.
For more information, please contact Rachel Schuck, BA, 650-736-1235.
Lead Sponsor
Stanford Investigators
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A Study of RG7314 to Investigate Efficacy and Safety in Individuals With Autism Spectrum Disorders (ASD)
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This multi-center, randomized, double-blind, parallel group, placebo-controlled, proof of concept study will investigate the efficacy and safety of RG7314 in adult participants with ASD. In Stage I of the study, participants will be randomized in 2:1 to receive daily oral doses of 1.5 milligrams (mg) RG7314 or placebo for 12 weeks. After an independent safety review, the study may proceed to Stage II. In Stage II of the study, additional participants will be randomized in 2:1 to receive daily oral doses of 4 mg RG7314 or placebo for 12 weeks. After an independent safety review, Stage III will be started wherein additional participants will be randomized in 2:1 to receive daily oral doses of 10 mg RG7314 or placebo for 12 weeks. During Stage III, safety will be reviewed by independent safety review twice and if no safety signal is observed, then additional participants will be randomized in 1:1:1 either to receive 1.5 milligrams per day (mg/day) or 10 mg/day RG7314 orally or placebo for 12 weeks in Stage IV.
Stanford is currently not accepting patients for this trial.
For more information, please contact SPECTRUM, .
Stanford Investigators
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A Study of Esomeprazole in Children With Autism
Not Recruiting
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Autism is a pervasive developmental disorder characterized by core deficits in social
behavior and communication and the presence of repetitive/stereotyped behaviors. The
objective of the study is to evaluate the efficacy of Esomeprazole as a treatment for social
communication deficits in children with Autism Spectrum Disorder (ASD). This prospective 12
week open-label study will invite 25 children with ASD between the ages of 2 and 6 years of
age to participate.
Stanford is currently not accepting patients for this trial.
For more information, please contact Robin Libove, (650)736-1235.
Lead Sponsor
Stanford Investigators
View full details
