Autism spectrum disorder
Conditions
Interventions
Four weeks administrations of TTA-121 3U once per day in morning and placebo once per day in evening After four weeks washout, four weeks administrations of placebo twice per day in morning and eveni
Sponsors
Hamamatsu University School of Medicine, Department of Psychiatry
Eligibility
Sex/Gender
Male
Inclusion 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 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
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 spectrum 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) Pariticipation 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 |
|---|---|
| The primary outcome is changes in ADOS reciprocity between just before and after each administration period. | — |
Secondary
| Measure | Time frame |
|---|---|
| ADOS communication and repetitive and restricted behavior, revised algorithm of social affect, and revised algorithm of repetitive and restricted behavior. Quantitative behavioral indices reflecting social deficits including gaze fixation time on social region during being talked and quantitative analysis of facial expression on videos recorded during ADOS administration. Clinical Global Impression, General Assessment of Functioning. | — |
Countries
Japan
Contacts
Public ContactHidenori Yamasue
Hamamatsu University Hospital, Center for Clinical Research Translational Research Center, TTA-121 recruiting office
Outcome results
None listed