Clinical trials: Autism
Schizophrenia, Autism-Related Irritability
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
The purpose of this study is to evaluate the long-term safety and tolerability of Xanomeline and Trospium Chloride for the treatment of psychiatric disorders in children and adolescents
- Trial name
- NCT07424404
- Testing
- KarXT, KarX-EC
- Where
- 104 sites in United States, Australia and 9 more
- Volunteers
- 400 people
- Sponsor
- Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Fragile X Syndrome (FXS), Autism Spectrum Disorder (ASD)
A Study to Investigate the Effects and Safety of Codabakalner for the Treatment of FXS in Male Participants and Adult Participants With ADS
This is a Study to Investigate the Effects and Safety of Codabakalner for the Treatment of Fragile X Syndrome in Male Participants and Adult Participants with Autism Spectrum Disorders
- Trial name
- NCT07439510
- Testing
- Codabakalner
- Volunteers
- 120 people
- Sponsor
- Spinogenix
Autism, Autism Spectrum Disorder
NTI164 in Autism Spectrum Disorder
This is a double-blind, randomised, placebo-controlled study investigating the efficacy of a full-spectrum medicinal cannabis plant extract on core and associated ASD symptoms over placebo.
- Conditions
- Autism, Autism Spectrum Disorder, Autism Disorder
- Trial name
- Beyond Harmony (NCT07257939)
- Testing
- NTI164
- Where
- 3 sites in Australia
- Volunteers
- 200 people
- Sponsor
- Fenix Innovation Group
Autism Spectrum Disorder
Effect of Limosilactobacillus Reuteri on Social Deficits in Children With Autistic Spectrum Disorder
This is a double-blind, randomized, placebo-controlled, parallel-group study in children with Autism Spectrum Disorder (ASD) to evaluate the effect of a probiotic product on the ASD symptoms.
- Trial name
- NCT07845253
- Testing
- Probiotics
- Where
- Argentina
- Volunteers
- 200 people
- Sponsor
- BioGaia AB
Irritability Associated With Autism Spectrum Disorder
A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder
The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.
- Trial name
- NCT07285798
- Testing
- KarXT, KarX-EC
- Where
- 67 sites in United States, France and 8 more
- Volunteers
- 176 people
- Sponsor
- Bristol-Myers Squibb
Schizophrenia, Bipolar Disorder
Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia, bipolar disorder or autism spectrum disorder.
- Conditions
- Schizophrenia, Bipolar Disorder, Autism Spectrum Disorder
- Trial name
- NCT06229210
- Testing
- Lumateperone
- Where
- 65 sites in United States, Colombia and 1 more
- Volunteers
- 300 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Irritability Associated With Autism Spectrum Disorder
Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients
This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients aged 5 to 17 years with a primary diagnosis of irritability associated with Autism Spectrum Disorder (ASD) based on Diagnostic and…
- Trial name
- NCT06690398
- Testing
- Lumateperone high dose, Lumateperone low dose
- Where
- 35 sites in United States
- Volunteers
- 160 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Irritability Associated With Autism Spectrum Disorder
Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients
This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients aged 5 to 17 years with a primary diagnosis of irritability associated with Autism Spectrum Disorder (ASD) based on Diagnostic and…
- Trial name
- NCT06706674
- Testing
- Lumateperone high dose, Lumateperone low dose
- Where
- 40 sites in United States
- Volunteers
- 160 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Bi-Polar Disorder, Autism Spectrum Disorder (ASD)
An Examination of the Performance of QbMobile in Differential Diagnosis Associated With ADHD Symptoms
The purpose of this study is to evaluate QbMobile's ability to collect objective data to identify specific symptom profiles in differential diagnoses (ASD, MDD, Bipolar Disorder and Anxiety Disorder) that are common with ADHD.
- Conditions
- Bi-Polar Disorder, Autism Spectrum Disorder (ASD), Major Depression Disorders, Separation Anxiety Disorder
- Trial name
- NCT07329673
- Testing
- Digital software application for cognitive performance and activity measurement (QbMobile, investigational device)
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Qbtech AB
Autism Spectrum Disorder, Social Communication Disorder
Safety and Efficacy of NDTx-03 in Children and Adolescents With ASD or SCD
The purpose of this study is to evaluate the safety of NDTx-03 used together with treatment as usual (TAU) and to determine whether NDTx-03 plus TAU is more effective than TAU alone in improving social situation recognition and…
- Trial name
- NCT07770867
- Testing
- NDTx-03, TAU
- Where
- 7 sites in South Korea
- Volunteers
- 156 people
- Sponsor
- Neudive Inc.
GAINS Expert Guiding Technology to Coach Life Skill Teaching
GAINS Expert Guiding Technology to Coach Life Skill Teaching
Based on proven techniques in operant conditioning, the expert behavior guiding functionality in GAINS to teach life skills will be evaluated.
- Trial name
- NCT07203105
- Testing
- GAINS expert guiding technology to coach life skill teaching
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Guiding Technologies Corporation
Autism Spectrum Disorder
Evaluating the Efficacy of NTI164 in Young People With Autism Spectrum Disorder
This is an 18 to 54 week study assessing the efficacy of Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) on the severity of autism spectrum disorder in young people.
- Trial name
- NCT05626959
- Testing
- NTI164
- Where
- Australia
- Volunteers
- 54 people
- Sponsor
- Fenix Innovation Group
Autism Spectrum Disorder
Safety and Efficacy of Oral Full-Spectrum Medicinal Cannabis Plant Extract in Children With Autism Spectrum Disorder.
This is a 20-week open-label study to evaluate the safety and efficacy of full-spectrum medicinal cannabis plant extract < 0.08% THC (FEN164) in children with Autism Spectrum Disorder.
- Trial name
- NCT05516407
- Testing
- FEN164
- Where
- Australia
- Volunteers
- 18 people
- Sponsor
- Fenix Innovation Group
Autism Spectrum Disorder, ASD
A Phase 2A Trial of DT402 for Autism Spectrum Disorder
A Phase 2A Trial of DT402 Open-Label Study in Adults with Autism Spectrum Disorder
- Trial name
- NCT07303907
- Testing
- DT402 (R-enantiomer of 3,4-methylenedioxymethamphetamine (MDMA))
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Definium Therapeutics US, Inc.
Irritability Associated With Autism Spectrum Disorder
A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism
The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.
- Trial name
- NCT07284745
- Testing
- KarXT, KarX-EC
- Where
- 39 sites in United States, Australia and 2 more
- Volunteers
- 176 people
- Sponsor
- Bristol-Myers Squibb
Autism Spectrum Disorder
Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder
Study ITI-007-035 is a Phase 1b, multicenter, open-label study to evaluate the safety, tolerability, and PK of lumateperone for pediatric patients with Autism Spectrum Disorder.
- Trial name
- NCT06557902
- Testing
- Lumateperone 10.5 mg capsule, Lumateperone 21 mg capsule, Lumateperone 5 mg ODT
- Where
- 7 sites in United States
- Volunteers
- 33 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Autism Spectrum Disorder
ML-004 Open-Label Extension Study in Adults and Adolescents With Autism Spectrum Disorders (ASD)
ML-004-003 is a multi-center, open-label extension study that will enroll approximately 120 adolescent and adult subjects with ASD that have completed study ML-004-002.
- Trial name
- NCT05889273
- Testing
- ML-004 (IR)/(ER) tablet
- Where
- 21 sites in United States, Australia and 1 more
- Volunteers
- 120 people
- Sponsor
- MapLight Therapeutics
Autism Spectrum Disorder (ASD)
TeleABA for Hospitalized Adolescents and Young Adults With Autism Spectrum Disorder
This study is evaluating whether a telehealth-based applied behavior analysis (ABA) program can improve the care of adolescents and young adults with autism spectrum disorder (ASD) who are hospitalized because of severe…
- Trial name
- NCT07701915
- Testing
- Standard Hospital Care, Telehealth Applied Behavior Analysis (TeleABA)
- Where
- 2 sites in United States
- Volunteers
- 120 people
- Sponsor
- Caring Technologies, Inc.
Autism Spectrum Disorder
Transcranial Photobiomodulation for Reducing Autism Symptoms in Children
The hypothesis of the study is that photobiomodulation reduces symptoms of autism. Participants will be children between the ages of 2 and 6, who have been diagnosed with moderate to severe autism.
- Trial name
- TPBMASD (NCT04660552)
- Testing
- Cognilum TM: Light Treatment Condition
- Where
- 2 sites in United States
- Volunteers
- 34 people
- Sponsor
- JelikaLite LLC
Autism Spectrum Disorder
Transcranial Photobiomodulation for Reducing Autism Symptoms in Children - Open Label Study (TPBMASDOL)
The hypothesis of the study is that photobiomodulation reduces symptoms of autism. Participants will be children between the ages of 2 and 7, who have been diagnosed with moderate to severe autism.
- Trial name
- NCT06359080
- Testing
- Cognilum TM: Light Treatment Condition
- Where
- 2 sites in United States
- Volunteers
- 25 people
- Sponsor
- JelikaLite LLC