UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014650
Receipt No. R000017043
Scientific Title Intranasal oxytocin in the treatment of schizophrenia
Date of disclosure of the study information 2014/08/01
Last modified on 2018/01/31

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Intranasal oxytocin in the treatment of schizophrenia
Acronym Intranasal oxytocin in the treatment of schizophrenia
Scientific Title Intranasal oxytocin in the treatment of schizophrenia
Scientific Title:Acronym Intranasal oxytocin in the treatment of schizophrenia
Region
Japan

Condition
Condition Schizophrenia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The primary aim of this study was to examine the safety and therapeutic effects of intranasal oxytocin in schizophrenia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II,III

Assessment
Primary outcomes The change of clinical symptoms calculated by the PANSS.
Key secondary outcomes The change of social cognition and the body weight.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oxytocin was dosed at 24 IU twice
a day for 12 weeks.
Interventions/Control_2
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
20 years-old <=
Age-upper limit
64 years-old >
Gender Male and Female
Key inclusion criteria The chronic schizphrenia patients whose body mass index was over 25.
Key exclusion criteria Participants were excluded if they had a prior medical history of central nervous system disease or severe head injury, pregnancy or the possibility of pregnancy, or if they met the criteria for substance abuse or dependence.



Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirosi Kunugi
Organization National Center of Neurology and Psychiatry
Division name Department of Mental Disorder Research, National Institute of Neuroscience
Zip code
Address 4-1-1, Ogawa-Higashi, Kodaira, Tokyo
TEL 0423412712
Email hkunugi@ncnp.go.jjp

Public contact
Name of contact person
1st name
Middle name
Last name Miho Ota
Organization National Center of Neurology and Psychiatry
Division name Department of Mental Disorder Research, National Institute of Neuroscience
Zip code
Address 4-1-1, Ogawa-Higashi, Kodaira, Tokyo
TEL 042-241-2712
Homepage URL http://www.ncnp.go.jp/nin/guide/r3/index.html
Email ota@ncnp.go.p

Sponsor
Institute the ethics committee of the National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization Strategic research program for brain sciences
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 国立精神・神経医療研究センター(東京都)

Other administrative information
Date of disclosure of the study information
2014 Year 08 Month 01 Day

Related information
URL releasing protocol http://www.ncnp.go.jp/nin/guide/r3/index.html
Publication of results Published

Result
URL related to results and publications http://www.ncnp.go.jp/nin/guide/r3/index.html
Number of participants that the trial has enrolled
Results
Oxytocin significantly reduced scores on the positive and negative syndrome scale, especially on the negative symptoms. As for cognition, there was an improvement of the verbal fluency. Furthermore, the change of the negative score in positive and negative syndrome scale showed a negative correlation with the gray matter volumes of the right insula and left cingulate cortex.
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
2014 Year 07 Month 31 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 01 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 03 Month 31 Day
Date trial data considered complete
2016 Year 03 Month 31 Day
Date analysis concluded
2016 Year 03 Month 31 Day

Other
Other related information No other information

Management information
Registered date
2014 Year 07 Month 25 Day
Last modified on
2018 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017043

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.