Clinical trials: Pervasive Development Disorders
Autism
A Trial of CM-AT in Children With Autism With All Levels of FCT (The Blum Study)
The purpose of this study is to determine whether CM-AT is safe and effective in treating the core symptoms of autism in children with all levels of fecal chymotrypsin.
- Trial name
- NCT02410902
- Testing
- CM-AT
- Where
- 31 sites in United States
- Volunteers
- 190 people, healthy volunteers welcome
- Sponsor
- Curemark
Autism Spectrum Disorder, Quality of Life
Essential Oils for Enhancing QOL in ASD
Essential oils (aromatic oils extracted from plant parts) are routinely used by the public and are available on the market. Investigators are conducting this study because it is unknown whether the essential oils formulations…
- Conditions
- Autism Spectrum Disorder, Quality of Life, Sleep, Anxiety
- Trial name
- NCT02543203
- Testing
- Reconnect, Coconut oil Comparator
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Jill Hollway
Autistic Disorder, Autism Spectrum Disorder
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of RO6953958 in Healthy Participants
This study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single- and multiple-ascending doses (SAD (Part 1) and MAD (Part 2)) and food effect (FE) of RO6953958 following oral…
- Conditions
- Autistic Disorder, Autism Spectrum Disorder, Child Development Disorders, Pervasive, Mental Disorders
- Trial name
- NCT04475848
- Testing
- RO6953958, Midazolam
- Where
- United Kingdom
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Autism Spectrum Disorder
A Study to Investigate the Effect of Esomeprazole and the Effect of Food on the Pharmacokinetics of Balovaptan in Healthy Volunteers
This study will investigate the effect of food and the effect of esomeprazole on the pharmacokinetics (PK) of a single dose of balovaptan in healthy volunteers.
- Trial name
- NCT04156646
- Testing
- Balovaptan, Esomeprazole
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Behavioral Symptoms, Autistic Disorder
Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)
This study will compare the effectiveness (how well the drug works) of aripiprazole with placebo (fixed dose) in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).
- Trial name
- NCT00337571
- Testing
- Aripiprazole
- Where
- 31 sites in United States
- Volunteers
- 218 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Autism
Lurasidone Pediatric Autism Study
This is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of 2 fixed doses of lurasidone (20 mg/day and 60 mg/day) for 6 weeks compared with placebo in pediatric and adolescent…
- Trial name
- NCT01911442
- Testing
- Lurasidone 20 mg daily, Lurasidone
- Where
- 41 sites in United States
- Volunteers
- 150 people
- Sponsor
- Sumitomo Pharma America, Inc.
Autism Spectrum Disorder
Behavioral and Neural Response to Memantine in Adolescents With Autism Spectrum Disorder
This study is a 12-week, randomized-controlled trial of memantine hydrochloride (Namenda) for the treatment of social impairment in adolescents with autism spectrum disorder (ASD).
- Trial name
- NCT01972074
- Testing
- Memantine
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Stress
Development of a Resiliency Training Program for Parents of Children With Autism Spectrum Disorder
This study has three aims: Phase I: Through focus group interviews with expert clinicians, leaders of organizations, and parents with children with ASD, this study aims to identify the psychosocial needs of parents of children…
- Trial name
- ASD (NCT02995408)
- Testing
- Relaxation Response Resiliency Program for Parents of Children with ASD
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Autism Spectrum Disorder
Effect of a Wide Spectrum Nutritional Supplement on Mitochondrial Function in Children With Autism Spectrum Disorder
The objective of this study is to evaluate the metabolic effects of a comprehensive wide-spectrum supplement for children with ASD to determine whether it physiologically targets mitochondrial pathways known to be abnormal in…
- Trial name
- NCT03835117
- Testing
- Wide-spectrum nutritional supplement
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Rossignol Medical Center
Autism Spectrum Disorder
Trial to Investigate the Safety and Efficacy of Cannabidiol Oral Solution (GWP42003-P; CBD-OS) in Children and Adolescents With Autism Spectrum Disorder
This study will be conducted to evaluate the efficacy of GWP42003-P, compared with placebo, in reducing symptom severity in children with Autism Spectrum Disorder (ASD).
- Trial name
- NCT04745026
- Testing
- GWP42003-P
- Where
- 23 sites in United States, Australia and 4 more
- Volunteers
- 103 people
- Sponsor
- Jazz Pharmaceuticals
ASD, Autism Spectrum Disorder
Cannabidiol for ASD Open Trial
This is a 6-week open trial to identify the optimal dosing of cannabidiol (CBD) in youth with autism spectrum disorder (ASD) and to identify primary and secondary outcomes for future controlled studies.
- Trial name
- NCT03900923
- Testing
- 98% pure CBD
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- NYU Langone Health
Tuberous Sclerosis Complex, Self-injury
Rapalogues for Autism Phenotype in TSC: A Feasibility Study
The purpose of this study is to assess the feasibility and safety of administering rapalogues, sirolimus or everolimus, in participants with Tuberous Sclerosis Complex (TSC) and self-injury and to measure cognitive and behavioral…
- Conditions
- Tuberous Sclerosis Complex, Self-injury, Autism
- Trial name
- RAPT (NCT01929642)
- Testing
- Sirolimus, Everolimus
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Autism Spectrum Disorder
Comparison of DSM-IV-TR and DSM-5 for ASD
The study aim is to prospectively compare DSM-IV-TR and DSM-5 criteria for Autism Spectrum Disorder (ASD) in a sample of 250 children and adolescents who meet DSM-IV-TR criteria for ASD and 150 children and adolescents referred…
- Trial name
- NCT02296502
- Testing
- DSM
- Where
- 5 sites in United States
- Volunteers
- 439 people
- Sponsor
- University of Pittsburgh
Autism Spectrum Disorder
The Listening Program® With Bone Conduction Headphones Changes Hypersensitivity to Sound and Behavioral Responses
There are limited approaches to specifically address auditory sensory over- and under-responsivity (SOR) in children with Autism Spectrum Disorder (ASD).
- Trial name
- NCT05009095
- Testing
- The Listening Program® with bone conduction headphones
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Children's Health
Autism
Validation of Indiana's Early Evaluation Hub System
The investigators' objective is to test an innovative method of autism diagnosis that integrates clinical evaluation and assessment of biobehavioral markers in a large high-risk community-referral sample of children in the…
- Trial name
- EAER21 (NCT06586788)
- Testing
- Eyelink Portable Duo, Integrated PCP Diagnosis and Eye-tracking Biomarker
- Where
- 7 sites in United States
- Volunteers
- 154 people
- Sponsor
- Indiana University
Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder
A SMART Design to Improve Sleep Disturbance in Adolescents With Neurodevelopmental Disorders
The objective of this K01 study was to pilot a sequential, multiple assignment, randomized trial (SMART) design to compare the impact of a sequence of sleep interventions, based on participant treatment response, to optimize…
- Conditions
- Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Sleep Disturbance
- Trial name
- NCT03730194
- Testing
- Melatonin, Bedtime Bank
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Nebraska
Autism Spectrum Disorder
The Effect of Play on Social and Motor Skills of Children With ASD
In this study, the investigators will compare effects of two types of 8-weeklong interventions: a) multimodal or b) general movement to facilitate social communication and motor skills of school-age children with Autism Spectrum…
- Trial name
- NCT04258254
- Testing
- Multimodal, General, Standard of Care
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- University of Delaware
Autism, ASD
The Effects of Oxytocin on Complex Social Cognition in Autism Spectrum Disorders
This study examines the effects of a single dose of intranasal oxytocin (vs. placebo) on complex social cognition in adults with autism spectrum disorders.
- Trial name
- NCT01183221
- Testing
- Syntocinon
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Alexander Kolevzon
Autism, Autism Spectrum Disorder
Photobiomodulation in Autism Spectrum Disorder (ASD)
The purpose of this 8-week open-label study is to assess the tolerability, safety, and efficacy of Transcranial LED Therapy in patients with Autism Spectrum Disorder (ASD).
- Trial name
- NCT03724552
- Testing
- Transcranial LED Therapy (Participants ages 9-17), Transcranial LED Therapy (Participants ages 18-59)
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Massachusetts General Hospital
Autism Spectrum Disorder
Teaching Academic Success Skills to Students With Autism Spectrum Disorders in Clinical Setting
The goal of the study is to develop an academic EF intervention, Teaching Academic Skills to Kids (TASK), for high functioning (i.e., IQ score ≥80) middle-school youth with ASD and EF deficits.
- Trial name
- TASK-R21 (NCT03606343)
- Testing
- Teaching Academic Skills to Kids
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati