Safety and Efficacy of NDTx-03 in Children and Adolescents With ASD or SCD
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-18
SponsorNeudive Inc.
About this trial
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 interaction in children and adolescents with autism spectrum disorder (ASD) or social communication disorder (SCD).
Eligibility criteria
Qualifiers
Children and adolescents aged 10 to 18 years.
Diagnosed with Autism Spectrum Disorder (ASD) or Social Communication Disorder (SCD) by the clinical judgment of a psychiatrist according to DSM-5 diagnostic criteria, based on the Autism Diagnostic Interview-Revised (ADI-R), Korean Wechsler Intelligence Scale for Children, Fifth Edition (K-WISC-V), and clinical assessment. Previously performed ADI-R and Wechsler intelligence scale results may be used; for Wechsler intelligence scales, any test type or version may be used, including K-WISC-V, WPPSI, or WAIS.
Full-Scale Intelligence Quotient (FSIQ) >= 70 or General Ability Index (GAI) >= 70 based on a Korean Wechsler intelligence scale (regardless of type or version, including K-WISC-V, WPPSI, or WAIS). Previously performed results may be used.
Able to use NDTx-03 installed on a smartphone, either independently or with assistance from a parent/legal guardian.
Disqualifiers
Clinically significant behavioral problems, emotional regulation problems, psychotic symptoms, or risk of self-harm or harm to others at a level that may affect the treatment process.
Severe acute or chronic medical or psychiatric disease.
Serious trauma or surgery within 4 weeks before the screening date.
Other severe neurological disease or disability, such as brain lesion disorder or mental disorder/disability.
Trial design
Treatments tested in this trial
- NDTx-03
- TAU
Treatment groups
156 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov