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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000005809 |
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Date of registration:
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21/06/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A single-blind and crossover study examining the efficacy of intranasal oxytocin administration for social impairments in subjects with pervasive developmental disorders
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Scientific title:
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A single-blind and crossover study examining the efficacy of intranasal oxytocin administration for social impairments in subjects with pervasive developmental disorders - Pilot study examining the efficacy of intranasal oxytocin administration for social impairments in subjects with pervasive developmental disorders |
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Date of first enrolment:
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2011/06/01 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006870 |
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Study type:
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Interventional |
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Study design:
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Cross-over Randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Haruhisa Ota |
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Address:
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6-11-11 kitakarasuyama, setagaya-ku, Tokyo
Japan |
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Telephone:
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03-3300-5231 |
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Email:
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Affiliation:
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Showa University School of Medicine Department of Neuropsychiatry |
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Name:
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Address:
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mri.kenkyu@gmail.com
Japan |
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Telephone:
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Email:
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Affiliation:
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Karasuyama Hospital, Showa University School of Medicine Department of Neuropsychiatry |
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Key inclusion & exclusion criteria
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Inclusion criteria:
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
Age minimum:
18years-old
Age maximum:
55years-old
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Pervasive developmental disorders
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Intervention(s)
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Single intranasal administration of 24 units oxytocin (Syntocinon spray)
Single intranasal administration of placebo
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Primary Outcome(s)
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psychological tasks related to social skills (face and facial expression recognition task, inference task utilizing social context), NIRS and eye tracking data
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Secondary Outcome(s)
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self rating scales, such as AQ(Autism Quatient), PARS(Pervasive Developmental Disorders Autism Society Japan Rating Scale), EPQ(Eysenck personality questionnaire), SPQ(Schizotypal Personality Questionnaire), TCI(Schizotypal Personality Questionnaire),SIQ(Social Intelligence Quantity)
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Source(s) of Monetary Support
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Japan Science and Technology Agency
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/12/2012 |
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URL:
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