Treatment Trials

763 Clinical Trials for Various Conditions

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ACTIVE_NOT_RECRUITING
Mitochondrial Dysfunction in Autism Spectrum Disorder
Description

Researchers at Arkansas Children's Hospital Research Institute are conducting a study about mitochondrial function in children. The study involves up to 5 visits to Arkansas Children's Hospital with fasting blood draws, behavioral assessments, and/or questionnaires. This study is not currently recruiting, but continues to follow those who were enrolled. There is no cost for visits or study-related exams. For further information, please contact the program manager, Leanna Delhey, at ldelhey@uams.edu or 501-364-4519

COMPLETED
Cognitive-Behavioral Therapy for Irritability in Adolescents With High Functioning Autism Spectrum Disorder
Description

In addition to the core symptoms, children and adolescents with Autism Spectrum Disorder (ASD) often exhibit disruptive behavior problems including irritability, tantrums, noncompliance, and aggression. This is a pilot study of Cognitive-Behavioral Therapy, also known as Anger Control Training, in adolescents with high-functioning ASD. CBT teaches children to recognize antecedents and consequences of problem behavior and to use emotion regulation and problem-solving skills to reduce irritability, aggression and noncompliance. This form of CBT has been well-studied in typically developing children with disruptive behavior and we are investigating if this treatment can be feasible and helpful, with appropriate modifications, for irritability and disruptive behavior in ASD.

COMPLETED
An Open-Label Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
Description

The purpose of this study is to evaluate the safety and tolerability of memantine in pediatric (6-12 years old) patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) and to identify responders for participation in a follow-up randomized withdrawal study.

TERMINATED
Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
Description

The objective of this study is to evaluate the long-term safety and tolerability of memantine in the treatment of pediatric patients with autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).

COMPLETED
Withdrawal Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified Previously Treated With Memantine
Description

The purpose of this randomized withdrawal study is to evaluate the safety, tolerability, and efficacy of memantine compared with placebo in pediatric patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).

COMPLETED
Guanfacine for the Treatment of Hyperactivity in Pervasive Developmental Disorder
Description

The purpose of this study is to determine whether guanfacine (trade name Intuniv) by itself or in combination with methylphenidate (also known as Ritalin) is helpful for treating hyperactivity in children and adolescents with a Pervasive Developmental Disorders (PDDs).

ACTIVE_NOT_RECRUITING
Genetic Contributions to Autism Spectrum Disorders
Description

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.

COMPLETED
D-Cycloserine and Social Skills Training in Autism Spectrum Disorders
Description

The purpose of this study is to determine the effectiveness of D-cycloserine for improving social impairment in child with pervasive developmental disorders (PDD).

TERMINATED
Memantine in Adult Autism Spectrum Disorder
Description

The purpose of this study is to see if memantine is helpful in managing problematic symptoms in adults with autism, Asperger's disorder, or Pervasive Developmental Disorder not otherwise specified (NOS).

COMPLETED
Study of Aripiprazole in the Treatment of Pervasive Developmental Disorders
Description

The purpose of this study is to develop a better tolerated and more effective pharmacologic treatment with individuals with Pervasive Developmental Disorder. This is a double-blind, placebo-controlled study of aripiprazole in the management of the maladaptive behaviors of Pervasive Developmental Disorder. The investigators hypothesize that aripiprazole will be more effective than placebo for reducing aggression, tantrum and self-injurious behavior in children with Pervasive Developmental Disorder.

COMPLETED
Autism Spectrum Disorders (ASD) Characterization Study
Description

The overarching aim of the study is to characterize children and adults with ASDs, and compare them with age-matched controls in relation to their functioning in family, academic, employment, and social spheres. Subjects will be comprehensively assessed in multiple non-overlapping domains of functioning, using psychiatric, cognitive, and psychosocial instruments.

COMPLETED
A Study of Oral N-Acetylcysteine in Children With Autism Spectrum Disorders
Description

The purpose of this study is to determine whether treatment with oral N-acetylcysteine (NAC) will improve behavior problems often associated with autism spectrum disorders.

COMPLETED
Services to Enhance Social Functioning in Adults With Autism Spectrum Disorders
Description

The purpose of this study is to test a novel, three-part cognitive behavioral treatment strategy to improve social functioning in adults with autism spectrum disorder. The treatment, named TUNE In (Training to Understand and Navigate Emotions and Interactions), includes components to address the many behavioral domains involved in social functioning, including social motivation, social anxiety, social cognition, social skills, and generalization of the skills to community settings. The Investigators will test the efficacy of TUNE In to improve social functioning in adults with autism spectrum disorder (ASD), using a randomized controlled trial using the SRS-2 as the primary outcome measure.

COMPLETED
Confirmatory Efficacy Trial of Cognitive Enhancement Therapy for Adult Autism Spectrum Disorder
Description

This study will investigate and confirm the efficacy of two psychological treatments for adults with autism spectrum disorder. Cognitive Enhancement Therapy (CET) is a cognitive remediation intervention that aims to help adults with problems in thinking, planning, and socialization. Enriched Supportive Therapy (EST) is an individual supportive therapy that aims to help adults learn about their condition, manage their emotions and stress, improve their social skills, and cope with everyday problems.

COMPLETED
A Study of Oxytocin for the Treatment of Social Impairment in Individuals With High Functioning Autism Spectrum Disorder
Description

This study is an 8-week pilot trial with oxytocin nasal spray (Syntocinon) as a treatment for social impairment in children and adults with high functioning autism spectrum disorders (ASD). The investigators hypothesize that oxytocin will be safe, tolerable, and effective in improving social deficits in individuals with ASD.

COMPLETED
Sulforaphane for the Treatment of Young Men With Autism Spectrum Disorder
Description

The aim of this randomized controlled trial is to determine if a nutritional supplement containing broccoli sprout and seed extracts, a rich source of sulforaphane, is effective in reducing core symptoms of autism spectrum disorder (ASD). The study will also explore the safety and tolerability of a sulforaphane supplement in young men with ASD, as well as its effects on challenging neuropsychiatric symptoms that are commonly associated with ASD, such as hyperactivity, irritability, and repetitive movements.

COMPLETED
Social Skills in Children With Autism Spectrum Disorders
Description

To evaluate whether a structured social skills program, called Social Skills Development,is superior to a wait list control group on measures of interpersonal interaction. The Social Skills Development (SSD) is a 16-week, group intervention that uses activities and peer tutors to promote interpersonal skills in children 8 to 11 years of age with Autism Spectrum Disorders.Following a diagnostic and social skills assessment,children are randomly assigned to SSD or wait list for 16 weeks. Children who were randomized to the wait list are offered SSD at Week 16. Children randomized to SSD are followed for 9 months to assess the durability of gains during the first 16 weeks.

COMPLETED
Psychotherapy for Anxiety in Children With Autism Spectrum Disorder
Description

Anxiety disorders affect 40 to 50% of children with autism spectrum disorders (ASD), contributing to substantial distress and impairment. The goal of this study is to examine the effectiveness of a personalized type of psychotherapy against standard-care psychotherapy for addressing anxiety in youth with ASD.

COMPLETED
An Open-Label Trial of Oxytocin in Adolescents With Autism Spectrum Disorders
Description

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.

COMPLETED
An Open-Label Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders
Description

The main objective of this exploratory 8-week pilot study is to evaluate the safety and efficacy of buspirone for the treatment of anxiety in youth (ages 6-17 years) with autism spectrum disorders. The study results will be used to generate hypothesis for a larger randomized controlled clinical trials with explicit hypotheses and sufficient statistical power.

TERMINATED
Open Label Extension Study of STX209 (Arbaclofen) in Autism Spectrum Disorders
Description

This is an open-label extension protocol that will provide necessary data on the safety, tolerability, pharmacokinetics and efficacy of STX209 among subjects with ASD.

TERMINATED
A Folinic Acid Intervention for Autism Spectrum Disorders
Description

Researchers at Arkansas Children's Hospital Research Institute are conducting a study looking at the effects of Folinic Acid on language in Autism Spectrum Disorder and language impairment. The study has 3 phases. Phase 1 confirms that your child has language impairment (there is no compensation for this visit). If language impairment is verified in the phase 1 screening, then your child will be eligible for phase 2. Phase 2 consists of receiving 12 weeks of folinic acid or an inactive placebo, in addition to several evaluations of your child's abilities and a single blood test. Children that complete phase 2 will be eligible for a 12 week open-label trial of folinic acid which is phase 3.

WITHDRAWN
Double-blind Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders
Description

The main objective of this exploratory 8 week pilot study is to evaluate the safety and efficacy of buspirone for the treatment of anxiety in youth (ages 6-17 years) with autism spectrum disorders. The study results will be used to generate hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power.

COMPLETED
Magnetic Resonance Spectroscopic and Diffusion Tensor Imaging of Adolescents With Autism Spectrum Disorders
Description

The primary objective of this study is to conduct magnetic resonance spectroscopic (MRS) and imaging (MRI) scans to assess the structural and neurochemical profile of the brain in 20 children and adolescents, 6-17 years old with Autism Spectrum Disorder (ASD). For comparison, MRS and MRI will also be obtained from 10 healthy control subjects, matched to the 20 subjects with ASD in age, sex, dexterity, and IQ. All eligible subjects will be administered a detailed assessment battery consisting of cognitive assessments (neuropsychological battery including subsets of the DANVA2 and the CANTAB) and measures of psychosocial functioning (SAICA and M-FES). The study includes 1-3 visits for the screening period at Massachusetts General Hospital (approximately 4 hours of assessments) and one scanning visit at McLean Hospital (approximately 1.5 hours). The investigators hypothesize that youth with ASD versus controls will exhibit increased glutamate concentrations, reflecting glutamatergic overactivity, and increased Cho concentrations, suggesting neuronal abnormality. Furthermore, the investigators hypothesize that compared to neurotypical controls, the structural integrity of white mater tracts will be disrupted in ASD.

COMPLETED
A Study of Memantine Hydrochloride (Namenda®) for Cognitive and Behavioral Impairment in Adults With Autism Spectrum Disorders
Description

The main objective of this study is to evaluate the safety and effectiveness of memantine (Namenda®) for cognitive and behavioral impairment in adults ages 18-50 years with autism spectrum disorders (ASD). This is an exploratory, 12-week, pilot study, seeking to determine whether Namenda is efficacious and well tolerated in the treatment of adults with ASD. The study results will be used to generate hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power.

COMPLETED
Mirtazapine Treatment of Anxiety in Children and Adolescents With Pervasive Developmental Disorders
Description

This study will determine the effectiveness of mirtazapine in reducing anxiety in children with autistic disorder, Asperger's disorder and Pervasive Developmental Disorder.

COMPLETED
Autism Spectrum Disorders (ASD) Driving Study
Description

The proposed pilot study will begin to assess whether driving impairments are included in the functional deficits associated with Autism Spectrum Disorders (ASDs). This will be completed by obtaining data on velocity, collision risk, and visual attention of subjects with ASDs who drive in a simulator. The study includes 2-3 visits for the screening period (approximately 6 hours of assessments) and one driving simulation visit (approximately 2.5 hours). The investigators expect to enroll 20 adolescents and adults (ages 16-50, inclusive) who have been identified as having an ASD from a prior diagnosis or participation in community conferences for individuals with ASDs.

TERMINATED
Omega-3 Fatty Acids Monotherapy in Children and Adolescents With Autism Spectrum Disorders
Description

The primary aim of this study is to examine the efficacy and tolerability of short-term omega-3 fatty acids monotherapy in youth with Autism Spectrum Disorders (ASD). The investigators hypothesize that Omega-3 fatty acids will be efficacious in improving the core and associated features of ASD in youth, and that Omega-3 fatty acids monotherapy will be safe and well tolerated by youth with ASD. The secondary aim of this study is to examine the neuropsychological effect of Omega-3 fatty acids monotherapy in youth with ASD. The investigators hypothesize that omega-3 fatty acids will be efficacious in improving cognitive functions in youth with ASD.

ACTIVE_NOT_RECRUITING
Phenotypic and Genetic Factors in Autism Spectrum Disorders
Description

The purpose of the study is to collect phenotypic (observable characteristics) and genetic information about individuals with Autism Spectrum Disorders (ASDs) and their families.

COMPLETED
Cognitive Enhancement Therapy for Adult Autism Spectrum Disorder
Description

This study will investigate and contrast the effects of two psychological treatments for adults with autism spectrum disorder. Cognitive Enhancement Therapy (CET) is a cognitive remediation intervention that aims to help adults with problems in thinking, planning, and socialization. Enriched Supportive Therapy (EST) is an individual supportive therapy that aims to help adults learn about their condition, manage their emotions and stress, improve their social skills, and cope with everyday problems.