UMIN-CTR Clinical Trial

Basic information
Public title	A pilot study for the efficacy of the non-benzodiazepine hypnotic or orexin receptor antagonist on insomnia in major depressive patients unresponsive to benzodiazepine hypnotic treatment: a randomized open-label trial.
Acronym	A pilot study for the efficacy of the non-benzodiazepine hypnotic or orexin receptor antagonist on insomnia in major depressive patients unresponsive to benzodiazepine hypnotic treatment: a randomized open-label trial.
Scientific Title	A pilot study for the efficacy of the non-benzodiazepine hypnotic or orexin receptor antagonist on insomnia in major depressive patients unresponsive to benzodiazepine hypnotic treatment: a randomized open-label trial.
Scientific Title:Acronym	A pilot study for the efficacy of the non-benzodiazepine hypnotic or orexin receptor antagonist on insomnia in major depressive patients unresponsive to benzodiazepine hypnotic treatment: a randomized open-label trial.
Region	Japan

Condition
Condition	major depressive disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Study for the efficacy of the non-benzodiazepine hypnotic or orexin receptor antagonist on insomnia in major depressive patients unresponsive to benzodiazepine hypnotic treatment.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The mean change in ISI and PSQI total scores from baseline at weeks 2 and 4.
Key secondary outcomes	1. The rate of remission in ISI and PSQI at 4 weeks. 2. The mean change in 6 components in PSQI scores from baseline at weeks 2 and 4; sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance and daytime dysfunction. 3. The mean change in BDI total scores from baseline at weeks 2 and 4. 4. The mean change in each items scores of BDI from baseline at weeks 4. 5. The mean change in DSST and DS scores from baseline at week 4. 6. The mean change in GAD-7 total scores from baseline at weeks 2 and 4. 7. The mean change in ISI and PSQI scores for each anxiety symptom from baseline at weeks 2 and 4.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Switching benzodiazepine to eszopiclone (1-3 mg/day)
Interventions/Control_2	Switching benzodiazepine to suvorexant (15-20 mg/day)
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	16 years-old <=
Age-upper limit	89 years-old >
Gender	Male and Female
Key inclusion criteria	Major depressive patients with insominia unresponssive to the treatment with benzodiazepine for at least 2 weeks.
Key exclusion criteria	1. Patients taking other hypnotics. 2. Patients judged not to be accurately taken. 3. Patients with severe physical disease. 4. Patients with a history of severe drug hypersensitivity or drug allergy. 5. Women who are pregnant or who wish to be pregnant during the study period, and lactating mother. 6. Patients taking agents causing insomnia. 7. Patients judged to be high-risk for substance abuse. 8. Patients judged to be high risk for suicide. 9. Patients judged to be inappropriate for participation by researchers.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Kazuo, Toshiya Middle name Last name Matsubara, Murai
Organization	Kyoto University Hospital
Division name	Department of Clinical Pharmacology and Therapeutics, Department of Neuropsychiatry
Zip code	606-8507
Address	54 Shogoin-Kawahara-cyo, Sakyo-ku, Kyoto
TEL	075-751-3581
Email	kmatsubara@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Yuki Middle name Last name Shigetsura
Organization	Kyoto University Hospital
Division name	Department of Clinical Pharmacology and Therapeutics
Zip code	606-8507
Address	54 Shogoin-Kawahara-cyo, Sakyo-ku, Kyoto
TEL	075-751-3581
Homepage URL
Email	sigetura@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Department of Clinical Pharmacology and Therapeutics, Kyoto University Hospital
Institute
Department

Funding Source
Organization	Grants-in-Aid for Scientific Research, Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyoto Univercity Graduate School and Faculty of Medicine Kyoto University Hospital Ethics Committe
Address	Yoshidakonoe-cho, Sakyo-ku, Kyoto
Tel	075-753-4680
Email	ethcom@kuhp.kyoto-u.ac.jp

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	2018 Year 01 Month 29 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	2017 Year 12 Month 04 Day
Date of IRB	2018 Year 03 Month 26 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date	2020 Year 04 Month 17 Day
Date of closure to data entry	2020 Year 04 Month 17 Day
Date trial data considered complete	2020 Year 04 Month 17 Day
Date analysis concluded	2020 Year 04 Month 17 Day

Other
Other related information

Management information
Registered date	2018 Year 01 Month 28 Day
Last modified on	2020 Year 06 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035282