A Trial of TTA-121 on Autism Spectrum Disorder

Hamamatsu University144 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

144

Conditions

Autism Spectrum Disorder

Interventions

TTA-121DRUG

A nove intranasal spray of oxytocin and placebo

Eligibility

Sex: MALEMin age: 18 YearsMax age: 54 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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) 2. Full scale Intelligent quotient above 80 as measured using the Wechsler Adult Intelligent Scale-III 3. Written informed consent for participating the trial Exclusion Criteria: 1. Diagnosis of bipolar disorder or schizophrenia spectrum disorder 2. 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 3. Instability in symptoms of comorbid mental disorders such as depressive disorders or anxiety disorders 4. History of changes in medication or doses of psychotropics within one month before registration 5. Current treatment with more than one psychotropics 6. History of hyper-sensitivity to oxytocin 7. History of seizures or traumatic brain injury with loss of consciousness for longer than 5 minutes 8. History of alcohol-related disorders, substance abuse, or addiction 9. Family history of male breast cancer 10. Subject who has severe complications 11. Known hypersensitivity to some drugs and foods 12. Subject who is not able to consent contraception during study period 13. Participation in another registration clinical trial and administration of investigational drug during 120 days before informed consent 14. Other Subjects whom a lead investigator or the patient's primary physician deems are not appropriate for this study

Locations (1)

Hamamatsu University School of Medicine

Hamamatsu, Shizuoka, Japan

Outcomes

Primary Outcomes

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

Changes in social reciprocity score (range: 0-14, Higher value represent a worth outcome) on Autism Diagnostic Observation Schedule module 4 between baseline and endpoint of each administration period

Time frame: 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

Secondary Outcomes

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

Changes in communication score (range: 0-8, Higher value represent a worth outcome) on Autism Diagnostic Observation Schedule module 4 between baseline and endpoint of each administration period

Time frame: 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

Efficacy on autism spectrum core symptom assessed by repetitive and restricted behavior score on the Autism Diagnostic Observation Schedule module 4

Changes in repetitive and restricted behavior score (range: 0-10, Higher value represent a worth outcome) on Autism Diagnostic Observation Schedule module 4 between baseline and endpoint of each administration period

Time frame: 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

Efficacy on autism spectrum core symptom assessed by revised algorithm score of social affect on the Autism Diagnostic Observation Schedule module 4

Changes in revised algorithm score of social affect (range: 0-20, Higher value represent a worth outcome) on Autism Diagnostic Observation Schedule module 4 between baseline and endpoint of each administration period

Data from ClinicalTrials.gov

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