UMIN-CTR Clinical Trial

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