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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007748
Receipt No. R000009114
Scientific Title The examination of the relations with sleep disturbance and the prognosis for the bipolar disorder
Date of disclosure of the study information 2013/03/31
Last modified on 2017/04/17

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Basic information
Public title The examination of the relations with sleep disturbance and the prognosis for the bipolar disorder
Acronym The examination of the relations with sleep disturbance and the prognosis for the bipolar disorder
Scientific Title The examination of the relations with sleep disturbance and the prognosis for the bipolar disorder
Scientific Title:Acronym The examination of the relations with sleep disturbance and the prognosis for the bipolar disorder
Region
Japan

Condition
Condition The insomnia patients with bipolar disorder diagnosised by DSM, and more 6 points of Pittsburgh Sleep Quality Index
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 We divide treatment for the sleep disturbance of the bipolar disorder into olanzapine, aripiprazole, flunitrazepam, We compared three groups of correlation to the degree of improvement of the sleep disturbance and remission of the bipolar disorder.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Young Mania Rating Scale
Pittsburgh Sleep Quality Index
Hamillton Depression Scale
Key secondary outcomes sleep scan
clock gene RNA expression

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Olanzapine medication group
Interventions/Control_2 Aripiprazole medication group
Interventions/Control_3 Flunitrazepam medication group
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
65 years-old >=
Gender Male and Female
Key inclusion criteria The patients of bipolar disorder diagnoded by DSM, and who had the insomnia with more 6 points of Pittsburgh Sleep Quality Index.
Key exclusion criteria The patients with a history of hypersensitivity for olanzapine, aripiprazole,flunitrazepam.
The patients with serious hepatic disorder.
The patients with diabetes, the patients with a history of diabetes.
The patients with acute narrow-angle glaucoma.
The patients with myasthenia gravis.
The women with during the pregnancy or the possibility to pregnancy.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichi Osada
Organization St. Marianna University School Of Medicine
Division name Neuropsychiatry
Zip code
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki
TEL 044-977-8111
Email k2osada@marianna-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenichi Osada
Organization St. Marianna University School Of Medicine
Division name Neuropsychiatry
Zip code
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki
TEL 044-977-8111
Homepage URL
Email k2osada@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School Of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2013 Year 03 Month 31 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 Terminated
Date of protocol fixation
2012 Year 04 Month 11 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 11 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
2012 Year 04 Month 13 Day
Last modified on
2017 Year 04 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009114

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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