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

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 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


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

Value
https://center6.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