UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014156 |
|---|---|
| Receipt number | R000016484 |
| Scientific Title | Efficacy and Safety of Sansoninto in Insomnia with Psychiatric Disorder: An Open-Label Study |
| Date of disclosure of the study information | 2014/06/04 |
| Last modified on | 2014/06/03 20:55:18 |
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Basic information
Public title
Efficacy and Safety of Sansoninto in Insomnia with Psychiatric Disorder: An Open-Label Study
Acronym
Sansoninto in Insomnia with Psychiatric Disorder
Scientific Title
Efficacy and Safety of Sansoninto in Insomnia with Psychiatric Disorder: An Open-Label Study
Scientific Title:Acronym
Sansoninto in Insomnia with Psychiatric Disorder
Region
| Japan |
Condition
Condition
Insomnina with Psychiatric Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The efficacy and safety of sansoninto was examined in adult psychiatric disorder patients with insomnia symptoms.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
PSQI
Key secondary outcomes
ISI, AIS, CGI-I
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Sansouninto Treatment
Interventions/Control_2
No treatment
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The subjects enrolled in the study were patients with psychiatric disorders, raging 27-80 years of age, with PSQI of greater than six. These patients 45 minutes or more failing asleep, slept less than six hours, and struggled with this issue continously for at least one month.
Key exclusion criteria
1) within three months of the study there had been a major incident.
2) working the nightshift.
3) lack of time or tining conflicts.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Miyaoka |
Organization
Shimane University School of Medicine
Division name
Psychiatry
Zip code
Address
Enyacho 89-1
TEL
0853-20-2262
miyanyan@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Miyaoka |
Organization
Shimane University School of Medicine
Division name
Psychiatry
Zip code
Address
Enyacho 89-1
TEL
0853-20-2262
Homepage URL
miyanyan@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University School of Medicine, Department of Psyvhiatry
Institute
Department
Personal name
Funding Source
Organization
Shimane University School of Medicine, Department of Psyvhiatry
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
| 2010 | Year | 09 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 03 | Day |
Last modified on
| 2014 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016484
