UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026332 |
|---|---|
| Receipt number | R000030227 |
| Scientific Title | The placebo controlled randomized double blind multicenter study to investigate effectiveness and safety of combination use of melatonin receptor agonist for dose reduction or interruptions of BZD and non-BZD hypnotics on chronic insomnia. |
| Date of disclosure of the study information | 2017/02/28 |
| Last modified on | 2020/08/31 13:26:52 |
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Basic information
Public title
The placebo controlled randomized double blind multicenter study to investigate effectiveness and safety of combination use of melatonin receptor agonist for dose reduction or interruptions of BZD and non-BZD hypnotics on chronic insomnia.
Acronym
The study of combination use of melatonin receptor agonist for dose reduction or interruptions of BZD and non-BZD hypnotics on chronic insomnia
Scientific Title
The placebo controlled randomized double blind multicenter study to investigate effectiveness and safety of combination use of melatonin receptor agonist for dose reduction or interruptions of BZD and non-BZD hypnotics on chronic insomnia.
Scientific Title:Acronym
The study of combination use of melatonin receptor agonist for dose reduction or interruptions of BZD and non-BZD hypnotics on chronic insomnia
Region
| Japan |
Condition
Condition
Chronic insomnia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effects on combination use of Ramelteon in the dose reduction or interruption process of (non-)BZD hypnotics during the dose reduction or interruption algorithm.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The achievement ratio of the 50% dose reduction of (non-)BZD hypnotics (Diazepam conversion value) at 12weeks or withdrawal without any deterioration of insomnia symptoms
The rate of subjects who achieved more than 50% dose reduction of (non-)BZD hypnotics (Diazepam conversion value) at 12 weeks or withdrawal since informed consent.
Key secondary outcomes
1) The achievement ratio of the 50% dose reduction (Diazepam conversion value) at 4weeks and 8weeks
2) The average of the dose reduction rate at 4weeks, 8weeks and 12weeks
3) The achievement ratio of the 100% dose reduction at 12weeks or withdrawal
4) The variation in total score of PSQI and AIS at 4weeks, 8weeks and 12weeks
5) The variation in PHQ-9 score at 4weeks, 8weeks and 12weeks
6) CIWA-B score at 4weeks, 8weeks and 12weeks
7) PGI score at 12weeks or withdrawal
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Co-administer following medication for 12 weeks since informed consent;
R group: taking capsule of Ramelteon 8mg once daily before sleeping.
Interventions/Control_2
Co-administer following medication for 12 weeks since informed consent;
PL group: taking capsule of Placebo once daily before sleeping.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects meeting Criteria 1 or 2 and Criteria 3 and all subsequent criteria will be included in the study:
1. Patients diagnosed as chronic insomnia having sleep onset disturbance, and with a duration of the disease of at least 6 months
2. Patients diagnosed with chronic insomnia comorbid with mood disorders (depression or bipolar disorder) can be included to this study if they have remission of mood symptoms.
3. Patients taking (non-)BZD hypnotics (including etizolam at bedtime) at a fixed dose in the following patterns since at least 1 month prior to consent (over 90% of drug compliance should be confirmed at the time of medical interview):
* Patients taking 2 drugs at the usual dose (1 unit)
*Patients taking 3 drugs at the usual dose (1 unit)
* Patients taking 4 drugs at the usual dose (1 unit)
* Patients taking a drug at 2-fold of the usual dose (2 units)
* Patients taking a drug at 2-fold of the usual dose (2 units) and a drug at the usual dose (1 unit)
* Patients taking a drug at 2-fold of the usual dose (2 units) and 2 drugs at the usual dose (1 unit)
* Patients taking 2 drugs at 2-fold of the usual dose (2 units)
4. Patients whoes symptoms of insomnia were stabilized, and the investigators determined that the (non-) BZD hypnotics could be reduced or discontinued
5. Patients aged 20 years or older at the time of consent
6. Patients who are willing to comply with algorithm for dose reduction and discontinuation
7. Patients who can understand the content of the study and provide consent to participate in the study in writing on their own will.
Key exclusion criteria
Subjects meeting any of the following criteria will not be included in the study:
1. Patients with secondary insomnia
2. Patients taking (non-)BZD hypnotics at a dose exceeding 2-fold of the usual dose
3. Patients taking barbiturate and non-barbiturate hypnotics and Suvorexant.
4. Patients taking hypnotics other than medicinal pharmaceuticals (including OTC, supplements believed to be effective for insomnia and melatonin)
5. Patients taking mianserin hydrochloride, mirtazapine, and trazodone hydrochloride
6. Patients taking antipsychotics
7. Patients taking anxiolytic or clonazepam at bedtime
*Patient taking anxiolytic and/or clonazepam at times except for bed-time will be included in the study. However, dosage and timing of administration can not be changed during the study period.
8. Patients who took ramelteon within 1 month prior to the informed consent
9. Patients in whom the dose of psychotropics except for the items 2-7 were changed within 1 month prior to the informed consent
10. Patients who are comorbid with depression or bipolar disordeand and in whom depressive symptoms have not remitted
11. Patients in whom frequency in Q9 of PHQ "thoughts that you would be better off dead or thoughts of hurting yourself in some way" is "more than half the days (in the past 2 weeks)" or the total score is 10 or higher
12. Patients with dementia, schizophrenia, drug dependence and alcoholic
13. Patients with liver/kidney disorder, female subjects who are pregnant or in breast-feeding, and malignant neoplasm
14. Night workers
15. Patients meeting contraindications for ramelteon
16. Other patients judged ineligible for participation in the study by the investigator
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Inoue |
Organization
Yoyogi Sleep Disorder Clinic
Foundation of Sleep and Health Science
Division name
No
Zip code
151-0053
Address
5-10-10, Yoyogi, Shibuya-ku, Tokyo 151-0053, Japan
TEL
03-6300-5401
inoue@somnology.com
Public contact
Name of contact person
| 1st name | Mina |
| Middle name | |
| Last name | Kobayashi |
Organization
Yoyogi Sleep Disorder Clinic
Division name
No
Zip code
151-0053
Address
5-10-10, Yoyogi, Shibuya-ku, Tokyo 151-0053, Japan
TEL
03-6300-5401
Homepage URL
kobayashi@somnology.com
Sponsor or person
Institute
Yoyogi Sleep Disorder Clinic
Foundation of Sleep and Health Science
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center of Neurology and Psychiatry Clinical Research Review Board
Address
4-1-1 Ogawa-Higashi, Kodaira,Tokyo 187-8551, Japan
Tel
042-341-2711
rinri-jimu@ncnp.go.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
| 2017 | Year | 02 | Month | 28 | 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
17
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
| 2016 | Year | 12 | Month | 18 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 28 | Day |
Last modified on
| 2020 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030227
