UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035302 |
|---|---|
| Receipt number | R000039850 |
| Scientific Title | Effect of oxytocin nasal spray on auditory automatic discrimination measured by mismatch negativity in schizophrenia |
| Date of disclosure of the study information | 2018/12/19 |
| Last modified on | 2019/06/24 15:18:59 |
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Basic information
Public title
Effect of oxytocin nasal spray on auditory automatic discrimination measured by mismatch negativity in schizophrenia
Acronym
Effect of oxytocin nasal spray on auditory automatic discrimination measured by mismatch negativity
Scientific Title
Effect of oxytocin nasal spray on auditory automatic discrimination measured by mismatch negativity in schizophrenia
Scientific Title:Acronym
Effect of oxytocin nasal spray on auditory automatic discrimination measured by mismatch negativity
Region
| Japan |
Condition
Condition
schizophrenia
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For treating progressively cognitive dysfunction in schizophrenia, oxytocin nasal sprays are thought to improve social cognition, facial expression recognition, and smell identification ability. MMN is thought to acutely reflect cognitive dysfunction in schizophrenia. The purpose of this study is to clarify the effect on auditory cognitive function by oxytocin and to apply MMN to social function assessment of schizophrenia.
In this study, it is to clarify whether the effect of treatment of oxytocin nasal spray improve MMN and identify MMN paradigm that is sensitive to cognitive function assessment of schizophrenia.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mismatch negativity(MMN)
Key secondary outcomes
Facial Emotion Selection Test(FEST)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Single administration of 24 IU of oxytocin nasal sprays to schizophrenia.
Interventions/Control_2
Single administration of 24 IU of placebo nasal sprays to schizophrenia.
Interventions/Control_3
Single administration of 24 IU of oxytocin nasal sprays to healthy subjects.
Interventions/Control_4
Single administration of 24 IU of placebo nasal sprays to healthy subjects.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients were diagnosed Schizophrenia in DSM-5 (Diagnostic and Statistical Manual of Mental Disorders), which was thought to be able to fully understand the contents of the experiment and its significance.
Key exclusion criteria
Exclusion criteria were epilepsy, mental retardation, a history of hypersensitivity to Oxytocin, drug abuse / dependence, continuous administration of Oxytocin, pregnancy, and a history of psychiatric or neurological disorders.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Ochiai |
| Middle name | |
| Last name | Haruka |
Organization
Fukushima Medical University
Division name
Department of Psychiatry
Zip code
9601247
Address
1, Hikarigaoka, Fukushima-shi, Fukushima
TEL
0245471331
haruka-o@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Ochiai |
| Middle name | |
| Last name | Haruka |
Organization
Fukushima Medical University
Division name
Department of Psychiatry
Zip code
9601247
Address
1, Hikarigaoka, Fukushima-shi, Fukushima
TEL
0245471331
Homepage URL
haruka-o@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University Medical Research Promotion Division Clinical Research Review Committee Secretariat
Address
1, Hikarigaoka, Fukushima-shi, Fukushima
Tel
0245471825
rs@fmu.ac.jp
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
| 2018 | Year | 12 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
66
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
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 08 | Day |
Last follow-up date
| 2019 | Year | 03 | 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
| 2018 | Year | 12 | Month | 18 | Day |
Last modified on
| 2019 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039850
| 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 |
