Autism Spectrum Disorder
Conditions
Brief 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
Interventions
DRUGTTA-121
A nove intranasal spray of oxytocin and placebo
Sponsors
Japan Agency for Medical Research and Development
Hamamatsu University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 54 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy on autism spectrum social core symptom assessed by social reciprocity score on the Autism Diagnostic Observation Schedule module 4 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy on autism spectrum core symptom assessed by repetitive and restricted behavior score on the Autism Diagnostic Observation Schedule module 4 | 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 | 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 |
| Efficacy on autism spectrum core symptom assessed by revised algorithm score of social affect on the Autism Diagnostic Observation Schedule module 4 | 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 | 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 |
| Efficacy on autism spectrum core symptom assessed by revised algorithm of repetitive and restricted behavior score on the Autism Diagnostic Observation Schedule module 4 | 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 | Changes in revised algorithm of 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 |
| Efficacy assessed by Clinical Global Impression-Improvement | At baseline, which was before and on the same day as the first administration, and at endpoint, which was assessed within 100 min after the last drug administration | Changes in Clinical Global Impression-Improvement (range: 1-7, Higher value represent a worse outcome) between baseline and endpoint of each administration period |
| Efficacy on autism spectrum core symptom assessed by communication score on the Autism Diagnostic Observation Schedule module 4 | 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 | 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 |
| Efficacy assessed by Global Assessment of Functioning | At baseline, which was before and on the same day as the first administration, and at endpoint, which was assessed within 100 min after the last drug administration | Changes in Global Assessment of Functioning (range: 1-100, Higher value represent a better outcome) between baseline and endpoint of each administration period |
| Efficacy assessed by gaze fixation time on social region | At baseline, which was before and on the same day as the first administration, and at endpoint, which was started approximately 60 min after the last drug administration | Changes in gaze fixation time on social region during being talked between baseline and endpoint of each administration period |
| Efficacy assessed by quantitative analysis of facial expression | 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 | Changes in quantitative measure of facial expression on videos recorded during ADOS administration between baseline and endpoint of each administration period |
| Efficacy assessed by Clinical Global Impression-Severity | At baseline, which was before and on the same day as the first administration, and at endpoint, which was assessed within 100 min after the last drug administration | Changes in Clinical Global Impression-Severity (range: 1-7, Higher value represent a worse outcome) between baseline and endpoint of each administration period |
Countries
Japan
Outcome results
None listed