UnknownPhase 2

A Trial of TTA-121 on Autism Spectrum Disorder

Japan144 participantsStarted 2018-02-27

Plain-language summary

To test efficacy and safety of a novel nasal spray of oxytocin on social deifies in autism spectrum disorder, and To compare effect sizes of different doses

Who can participate

Age range18 Years – 54 Years

SexMALE

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Inclusion criteria

✓. Diagnosis of autism spectrum disorder based on Diagnostic and Statistical Manual of Mental Disorders-V with score exceeding the cut-off value of 10 for qualitative abnormalities in social reciprocity on Autism Diagnostic Interview Revised (ADIR)
✓. Full scale Intelligent quotient above 80 as measured using the Wechsler Adult Intelligent Scale-III
✓. Written informed consent for participating the trial

Exclusion criteria

✕. Diagnosis of bipolar disorder or schizophrenia spectrum disorder
✕. Primary diagnosis of depressive disorders, obsessive-compulsive and related disorders, anxiety disorders, trauma- and stressor-related disorders, dissociative disorders, somatic symptom and related disorders, or neurodevelopmental disorders other than autism spectr um disorder
✕. Instability in symptoms of comorbid mental disorders such as depressive disorders or anxiety disorders
✕. History of changes in medication or doses of psychotropics within one month before registration
✕. Current treatment with more than one psychotropics
✕. History of hyper-sensitivity to oxytocin
✕. History of seizures or traumatic brain injury with loss of consciousness for longer than 5 minutes
✕. History of alcohol-related disorders, substance abuse, or addiction

What they're measuring

Efficacy on autism spectrum social core symptom assessed by social reciprocity score on the Autism Diagnostic Observation Schedule module 4

Timeframe: At baseline, which was before and on the same day as the first administration, and at endpoint, which was started approximately 15 min after the last drug administration

Trial details

NCT IDNCT03466671

SponsorHamamatsu University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-03-16

View on ClinicalTrials.gov More Autism Spectrum Disorder trials