Overview
A Trial of TTA-121 on Autism Spectrum Disorder
Status:
Active, not recruiting
Active, not recruiting
Trial end date:
2020-03-30
2020-03-30
Target enrollment:
0
0
Participant gender:
Male
Male
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 dosesPhase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Hamamatsu UniversityCollaborator:
Japan Agency for Medical Research and Development
Criteria
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