UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014650 |
|---|---|
| Receipt number | 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 11:42:51 |
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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
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
ota@ncnp.go.p
Sponsor or person
Institute
the ethics committee of the National Center of Neurology and Psychiatry
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
