Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Japan Agency for Medical Research and Development | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose once per day and placebo | Other | 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. |
|
| Low dose twice per day and placebo | Other | 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. |
|
| High dose once per day and placebo | Other | 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. |
|
| High dose twice per day and placebo | Other | 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. |
|
| Placebo and low dose once per day | Other | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TTA-121 | Drug | A nove intranasal spray of oxytocin and placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy on autism spectrum social core symptom assessed by social reciprocity score on the Autism Diagnostic Observation Schedule module 4 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy on autism spectrum core symptom assessed by communication score on the Autism Diagnostic Observation Schedule module 4 | 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 | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hidenori Yamasue, MD, PhD | Department of Psychiatry, Hamamatsu University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamamatsu University School of Medicine | Hamamatsu | Shizuoka | 431-3192 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38461957 | Derived | Wakuda T, Benner S, Uemura Y, Nishimura T, Kojima M, Kuroda M, Matsumoto K, Kanai C, Inada N, Harada T, Kameno Y, Munesue T, Inoue J, Umemura K, Yamauchi A, Ogawa N, Kushima I, Suyama S, Saito T, Hamada J, Kano Y, Honda N, Kikuchi S, Seto M, Tomita H, Miyoshi N, Matsumoto M, Kawaguchi Y, Kanai K, Ikeda M, Nakamura I, Isomura S, Hirano Y, Onitsuka T, Ozaki N, Kosaka H, Okada T, Kuwabara H, Yamasue H. Oxytocin-induced increases in cytokines and clinical effect on the core social features of autism: Analyses of RCT datasets. Brain Behav Immun. 2024 May;118:398-407. doi: 10.1016/j.bbi.2024.03.013. Epub 2024 Mar 8. | |
| 35067719 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo and low dose twice per day | Other | 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. |
|
| Placebo and high dose once per day | Other | 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. |
|
| Placebo and high dose twice per day | Other | 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. |
|
| Efficacy on autism spectrum core symptom assessed by repetitive and restricted behavior score on the Autism Diagnostic Observation Schedule module 4 | 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 | 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 score of social affect on the Autism Diagnostic Observation Schedule module 4 | 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 | 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 | 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 | 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 | Changes in Clinical Global Impression-Improvement (range: 1-7, Higher value represent a worse outcome) between baseline and endpoint of each administration period | 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 | Changes in Clinical Global Impression-Severity (range: 1-7, Higher value represent a worse outcome) between baseline and endpoint of each administration period | 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 Global Assessment of Functioning | Changes in Global Assessment of Functioning (range: 1-100, Higher value represent a better outcome) between baseline and endpoint of each administration period | 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 gaze fixation time on social region | Changes in gaze fixation time on social region during being talked between baseline and endpoint of each administration period | 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 |
| Efficacy assessed by quantitative analysis of facial expression | Changes in quantitative measure of facial expression on videos recorded during ADOS administration between baseline and endpoint of each administration period | 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 |
| Derived |
| Yamasue H, Kojima M, Kuwabara H, Kuroda M, Matsumoto K, Kanai C, Inada N, Owada K, Ochi K, Ono N, Benner S, Wakuda T, Kameno Y, Inoue J, Harada T, Tsuchiya K, Umemura K, Yamauchi A, Ogawa N, Kushima I, Ozaki N, Suyama S, Saito T, Uemura Y, Hamada J, Kano Y, Honda N, Kikuchi S, Seto M, Tomita H, Miyoshi N, Matsumoto M, Kawaguchi Y, Kanai K, Ikeda M, Nakamura I, Isomura S, Hirano Y, Onitsuka T, Kosaka H, Okada T. Effect of a novel nasal oxytocin spray with enhanced bioavailability on autism: a randomized trial. Brain. 2022 Apr 18;145(2):490-499. doi: 10.1093/brain/awab291. |