An Early Phase II Trial for Efficacy and Safety of TTA-121 on Autism Spectrum Disorder
Overview
- Phase
- Phase 2
- Intervention
- TTA-121
- Conditions
- Autism Spectrum Disorder
- Sponsor
- Hamamatsu University
- Enrollment
- 144
- Locations
- 1
- Primary Endpoint
- Efficacy on autism spectrum social core symptom assessed by social reciprocity score on the Autism Diagnostic Observation Schedule module 4
- Last Updated
- 6 years ago
Overview
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
Investigators
Hidenori Yamasue, M.D., Ph.D.
Professor
Hamamatsu University
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
High dose twice per day and placebo
Four weeks administrations of TTA-121 10U twice per day in morning and evening. After four weeks washout, four weeks administrations of placebo twice per day in morning and evening.
Intervention: TTA-121
Low dose once per day and placebo
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 evening.
Intervention: TTA-121
Low dose twice per day and placebo
Four weeks administrations of TTA-121 3U twice per day in morning and evening. After four weeks washout, four weeks administrations of placebo twice per day in morning and evening.
Intervention: TTA-121
High dose once per day and placebo
Four weeks administrations of TTA-121 10U 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 evening.
Intervention: TTA-121
Placebo and low dose once per day
Four weeks administrations of placebo twice per day in morning and evening. After four weeks washout, four weeks administrations of TTA-121 3U once per day in morning and placebo once per day in evening.
Intervention: TTA-121
Placebo and low dose twice per day
Four weeks administrations of placebo twice per day in morning and evening. After four weeks washout, four weeks administrations of TTA-121 3U twice per day in morning and evening.
Intervention: TTA-121
Placebo and high dose once per day
Four weeks administrations of placebo twice per day in morning and evening. After four weeks washout, four weeks administrations of TTA-121 10U once per day in morning and placebo once per day in evening.
Intervention: TTA-121
Placebo and high dose twice per day
Four weeks administrations of placebo twice per day in morning and evening. After four weeks washout, four weeks administrations of TTA-121 10U twice per day in morning and evening.
Intervention: TTA-121
Outcomes
Primary Outcomes
Efficacy on autism spectrum social core symptom assessed by social reciprocity score on the Autism Diagnostic Observation Schedule module 4
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
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 Outcomes
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)