UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024941 |
|---|---|
| Receipt number | R000028696 |
| Scientific Title | Suvorexant for the treatment of insomnia in patients with psychiatric disorders |
| Date of disclosure of the study information | 2016/11/22 |
| Last modified on | 2019/06/24 11:52:23 |
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Basic information
Public title
Suvorexant for the treatment of insomnia in patients with psychiatric disorders
Acronym
Suvorexant for insomnia in patients with psychiatric disorders
Scientific Title
Suvorexant for the treatment of insomnia in patients with psychiatric disorders
Scientific Title:Acronym
Suvorexant for insomnia in patients with psychiatric disorders
Region
| Japan |
Condition
Condition
psychiatric disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of study is to examine whether suvorexant has a benefit for the treatment of insomnia in patients with psychiatric disorders
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
sleep latency, total sleep time, wake After Sleep Onset
Key secondary outcomes
individual adverse events
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
All the subjects received a fixed dose of suvorexant (20 mg if ages 18-64 or 15 mg if age more than 64 years) for seven consecutive nights.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients meet the following inclusion criteria (4days > or = one week): sleep latency > or = 30 minutes, total sleep time < 6 hours, wake after sleep onset > 1.
Key exclusion criteria
Patients meet contraindication of suvorexant
Patients with substance abuse or dependence (excluding nicotine and caffeine) meeting DSM-IV-TR criteria
Patients having severe physical disease
Patients who are pregnant or may become pregnant
Patients who had made suicide attempt within the past year
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nakao Iwata |
Organization
Fujita Health University School of Medicine
Division name
Department of Psychiatry
Zip code
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi. 470-1192. Japan
TEL
0562-93-9250
nakao@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taro Kishi |
Organization
Fujita Health University School of Medicine
Division name
Department of Psychiatry
Zip code
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi. 470-1192. Japan
TEL
0562-93-9250
Homepage URL
tarok@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
| 2016 | Year | 11 | Month | 22 | 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
| 2016 | Year | 09 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 05 | Month | 25 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 25 | Day |
Date analysis concluded
| 2018 | Year | 05 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 22 | Day |
Last modified on
| 2019 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028696
