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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035302
Receipt No. 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

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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
Email 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
Email haruka-o@fmu.ac.jp

Sponsor
Institute Fukushima Medical University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039850

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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