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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000004393 |
Receipt No. | R000005250 |
Scientific Title | Searching neural correlates of changes in social impairments induced by intranasal oxytocin administration and its association with genotypes related to oxytocin in subjects with autism spectrum disorder |
Date of disclosure of the study information | 2010/10/15 |
Last modified on | 2011/10/13 |
Basic information | ||
Public title | Searching neural correlates of changes in social impairments induced by intranasal oxytocin administration and its association with genotypes related to oxytocin in subjects with autism spectrum disorder | |
Acronym | Searching changes in brain activation induced by intranasal oxytocin and its association with genotypes related to oxytocin in subjects with autism spectrum disorder | |
Scientific Title | Searching neural correlates of changes in social impairments induced by intranasal oxytocin administration and its association with genotypes related to oxytocin in subjects with autism spectrum disorder | |
Scientific Title:Acronym | Searching changes in brain activation induced by intranasal oxytocin and its association with genotypes related to oxytocin in subjects with autism spectrum disorder | |
Region |
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Condition | ||
Condition | Autism spectrum disorder | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | YES |
Objectives | |
Narrative objectives1 | 1) Examining functional Magnetic Resonance Imaging signal changes induced by intranasal oxytocin administration in subjects with autism spectrum disorder
2) Examining association between functional Magnetic Resonance Imaging signal changes induced by intranasal oxytocin and genotypes related to oxytocin in subjects with autism spectrum disorder |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Bold signal changes of functional Magnetic Resonance Imaging |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Cross-over |
Randomization | Randomized |
Randomization unit | |
Blinding | Double blind -all involved are blinded |
Control | Placebo |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Single intranasal administration of 24 units oxytocin (Syntocinon spray) | |
Interventions/Control_2 | Single intranasal administration of placebo | |
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Interventions/Control_5 | ||
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male | |||
Key inclusion criteria | 1) Subjects diagnosed with high-functioning autism, Asperger disorder, or pervasive developmental disorder not otherwise specified using Autism Diagnostic Interview-Revised
2) Subjects with normal intelligent (Verbal IQ > 90 and total IQ > 80 measured with Wechsler Adult Intelligent Scale Revised) |
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Key exclusion criteria | 1) History of allergy for oxytocin
2) Cannot enter Magnetic Resonance Scanner 3) History of traumatic brain injury with any known cognitive consequences or loss of consciousness for more than 5 minutes 4) History of substance abuse or addiction 5) Instabilized with psychiatric comorbidity |
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Target sample size | 20 |
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Name of lead principal investigator |
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Organization | Graduate School of Medicine, University of Tokyo | ||||||
Division name | Department of Neuropsychiatry | ||||||
Zip code | |||||||
Address | 7-3-1 Hongo, Bunkyo-ku, Tokyo | ||||||
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Organization | The University of Tokyo Hospital | ||||||
Division name | Clinical Research Center | ||||||
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TEL | 3-5800-8743 | ||||||
Homepage URL | |||||||
Sponsor | |
Institute | Department of Neuropsychiatry, Graduate School of Medicine, University of Tokyo |
Institute | |
Department |
Funding Source | |
Organization | Japan Science and Technology Agency |
Organization | |
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Category of Funding Organization | Other |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
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IND to MHLW |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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Progress | |||||||
Recruitment status | Completed | ||||||
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Management information | |||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005250 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |