Status:
UNKNOWN
A Trial of TTA-121 on Autism Spectrum Disorder
Lead Sponsor:
Hamamatsu University
Collaborating Sponsors:
Japan Agency for Medical Research and Development
Conditions:
Autism Spectrum Disorder
Eligibility:
MALE
18-54 years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- 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
- 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
- Family history of male breast cancer
- Subject who has severe complications
- Known hypersensitivity to some drugs and foods
- Subject who is not able to consent contraception during study period
- Participation in another registration clinical trial and administration of investigational drug during 120 days before informed consent
- Other Subjects whom a lead investigator or the patient's primary physician deems are not appropriate for this study
Key Trial Info
Start Date :
February 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2020
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT03466671
Start Date
February 27 2018
End Date
March 30 2020
Last Update
December 20 2019
Active Locations (1)
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1
Hamamatsu University School of Medicine
Hamamatsu, Shizuoka, Japan, 431-3192