UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The examination of the relations with sleep disturbance and the prognosis for the bipolar disorder
Title of the study (Brief title)	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	Kenichi Osada
Organization	St. Marianna University School Of Medicine
Division name	Neuropsychiatry
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki
TEL	044-977-8111
Email	k2osada@marianna-u.ac.jp

Public contact
Name of contact person	Kenichi Osada
Organization	St. Marianna University School Of Medicine
Division name	Neuropsychiatry
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 04 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000009114