UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031032 |
|---|---|
| Receipt number | R000035282 |
| 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. |
| Date of disclosure of the study information | 2018/01/29 |
| Last modified on | 2020/06/28 17:51:48 |
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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
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
sigetura@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Clinical Pharmacology and Therapeutics, Kyoto University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035282
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