UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005809 |
|---|---|
| Receipt number | R000006870 |
| Scientific Title | A single-blind and crossover study examining the efficacy of intranasal oxytocin administration for social impairments in subjects with pervasive developmental disorders |
| Date of disclosure of the study information | 2011/06/21 |
| Last modified on | 2014/06/10 15:25:54 |
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Basic information
Public title
A single-blind and crossover study examining the efficacy of intranasal oxytocin administration for social impairments in subjects with pervasive developmental disorders
Acronym
Pilot study examining the efficacy of intranasal oxytocin administration for social impairments in subjects with pervasive developmental disorders
Scientific Title
A single-blind and crossover study examining the efficacy of intranasal oxytocin administration for social impairments in subjects with pervasive developmental disorders
Scientific Title:Acronym
Pilot study examining the efficacy of intranasal oxytocin administration for social impairments in subjects with pervasive developmental disorders
Region
| Japan |
Condition
Condition
Pervasive developmental disorders
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1) Examining the efficacy of intranasal oxytocin administration for social impairments in subjects with pervasive developmental disorders
2) Examining the safety of intranasal oxytocin administration in subjects with pervasive developmental disorders
3) Examining changes in social impairments, as revealed by psychological tasks such as recognizing facial expressions and eye-tracking, induced by intranasal oxytocin administration in subjects with pervasive developmental disorders
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
psychological tasks related to social skills (face and facial expression recognition task, inference task utilizing social context), NIRS and eye tracking data
Key secondary outcomes
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)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Single intranasal administration of 24 units oxytocin (Syntocinon spray)
Interventions/Control_2
Single intranasal administration of placebo
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 55 | years-old | > |
Gender
Male
Key inclusion criteria
1) Subjects diagnosed with high-functioning autism, Asperger disorder, or pervasive developmental disorder not otherwise specified using DSM-IV
2) Subjects with normal intelligent total IQ > 80 measured with Wechsler Adult Intelligent Scale
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
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruhisa Ota |
Organization
Showa University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
6-11-11 kitakarasuyama, setagaya-ku, Tokyo
TEL
03-3300-5231
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Karasuyama Hospital, Showa University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
mri.kenkyu@gmail.com
TEL
Homepage URL
Sponsor or person
Institute
Department of Neuropsychiatry, Showa University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2010 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 20 | Day |
Last modified on
| 2014 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006870
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
