Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
144 participants
INTERVENTIONAL
2018-02-27
2020-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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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.
TTA-121
A nove intranasal spray of oxytocin and placebo
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.
TTA-121
A nove intranasal spray of oxytocin and placebo
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.
TTA-121
A nove intranasal spray of oxytocin and placebo
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.
TTA-121
A nove intranasal spray of oxytocin and placebo
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.
TTA-121
A nove intranasal spray of oxytocin and placebo
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.
TTA-121
A nove intranasal spray of oxytocin and placebo
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.
TTA-121
A nove intranasal spray of oxytocin and placebo
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.
TTA-121
A nove intranasal spray of oxytocin and placebo
Interventions
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TTA-121
A nove intranasal spray of oxytocin and placebo
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
54 Years
MALE
No
Sponsors
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Japan Agency for Medical Research and Development
OTHER_GOV
Hamamatsu University
OTHER
Responsible Party
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Hidenori Yamasue, M.D., Ph.D.
Professor
Principal Investigators
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Hidenori Yamasue, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Psychiatry, Hamamatsu University School of Medicine
Locations
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Hamamatsu University School of Medicine
Hamamatsu, Shizuoka, Japan
Countries
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References
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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.
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.
Other Identifiers
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UMIN000031412
Identifier Type: -
Identifier Source: org_study_id