UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	long-term effectiveness of eszopiclone on chronic insomina disorder in middle-aged women
Title of the study (Brief title)	long-term effectiveness of eszopiclone on chronic insomina disorder in middle-aged women
Region	Japan

Condition
Condition	menopausal symptoms/chronic insomnia disorder
Classification by specialty	Obsterics and gynecology Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of eszopiclone on subjective and objective sleep parameters in middle-aged women with chronic insomnia disorder
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	changes in objective sleep parameters measured by actigraphy after 12 and 24 weeks of treatment
Key secondary outcomes	changes in Pittsburgh Sleep Quality Index, Athens Insomnia Scale, Epworth Sleepiness Scale, St. Marys Hospital Sleep Questionnaire, Menopause Health Related Quality of Life Questionnaire, and Hospital Anxiety and Depression Scale after 12 and 24 weeks of treatment

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	24-week treatment with 2 mg/day of eszopiclone
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	40 years-old <=
Age-upper limit	60 years-old >
Gender	Female
Key inclusion criteria	patients who have subjective insomnia scoring 6 or more on the Athens Insomnia Scale and are diagnosed with chronic insomnia disorder by ICSD-3 defnition
Key exclusion criteria	women who are already treated with estrogens, antidepressants, anxiolytics, hypnotics etc. that are supposed to have effects on insomnia symptoms in middle-aged women
Target sample size	10

Research contact person
Name of lead principal investigator	Masakazu Terauchi
Organization	Tokyo Medical and Dental University
Division name	Department of Women's Health
Address	Yushima 1-5-45, Bunkyo, Tokyo
TEL	03-5803-4605
Email	teragyne@tmd.ac.jp

Public contact
Name of contact person	Masakazu Terauchi
Organization	Tokyo Medical and Dental University
Division name	Department of Women's Health
Address	Yushima 1-5-45, Bunkyo, Tokyo
TEL	03-5803-4605
Homepage URL
Email	teragyne@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Tokyo Medical and Dental University
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	2016 Year 10 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 08 Month 19 Day
Anticipated trial start date	2016 Year 10 Month 01 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	2016 Year 08 Month 19 Day
Last modified on	2016 Year 08 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027282