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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024941
Receipt No. 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

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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
Email 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
Email tarok@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University School of Medicine
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028696

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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