Clinical trial NCT02669082: The Exploratory Study to Investigate the Effect of Ramelteon for Insomnia Patients With Major Depressive Disorder by Using Actigraphy
Official title: The Exploratory Study to Investigate the Effect of Ramelteon for Insomnia Patients With Major Depressive Disorder by Using Actigraphy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Insomnia
Major Depressive Disorder
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2016-01-29
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate exploratorily the effect of ramelteon 8 mg once daily for 8 weeks in the treatment of insomnia patients with depression by using actigraphy.

Detailed description: The drug being tested in this study is called ramelteon. Ramelteon is being tested to treat people who have insomnia with depression. This study will look at sleep activity of participants who take ramelteon.

The study will enroll approximately 30 patients. Participants will be administered:

• Ramelteon 8 mg

Participants will be asked to take 1 tablet orally at bedtime. This multi-center study will be conducted in Japan. The overall period to participate in this study is 9 weeks (Run-in period for 1 week and treatment period for 8 weeks). Participants will make multiple visits to clinic including the final visit 8 weeks after the start of treatment.

Eligibility criteria: Inclusion Criteria:

1. Has difficulty in initiating sleep at least 3 days per week for at least 4 weeks at the time of informed consent.
2. Has Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5)-defined depression.
3. Man or woman between 20 and 64 years of age, inclusive, at the time of informed consent.
4. Outpatient.
5. Meets either of the following criteria based on the 17-item Hamilton Rating Scale for Depression (HAM-D17) both at the start of the run-in period and the start of the study treatment period: has a score of 2 for "6: Insomnia Early", or has a score of 1 for "6: Insomnia Early" AND a score of at least 3 in total for "7: Insomnia Middle" and "8: Insomnia Late".
6. Has a total HAM-D17 score of 16 or under both at the start of the run-in period and the start of the study treatment period.
7. Under treatment of the same antidepressant agents on a stable dose for at least 4 weeks before the start of the run-in period.
8. Goes to bed routinely in a daily life (time for bed between 21.00 p.m. and 1.00 a.m. at least 4 days per week).
9. Actigraphy shows at least 3 days with sleep latency 30 minutes or longer AND total nocturnal sleep time 6.5 hours or shorter on the same day during the run-in period.
10. In the opinion of the principal investigator or investigator, is capable of understanding the contents of the study and complying with study requirements.
11. Is capable of signing and dating the informed consent form in person before any study procedures.

Exclusion Criteria:

1. Has a history of hypersensitivity to ramelteon and melatonin.
2. Has severe liver disorder.
3. Took ramelteon within 4 weeks before the informed consent.
4. Using any insomnia medications (including investigational drugs and unapproved drugs) for 2 weeks before the treatment period.
5. Shift worker or night worker.
6. Has complications of psychiatric or neurological diseases that affect sleep state other than depression.
7. Has a HAM-D17 score of at least 1 for"11: Suicide" at the start of the run-in period or the start of the study treatment period, or any suicide attempts within 24 weeks before or during the run-in period.
8. Pregnant woman, nursing mother, or woman who plans to become pregnant or donate eggs before the informed consent, during the study period or within 4 weeks after the end of the study.
9. Is participating in any other investigational or post-marketing clinical trial/study.
10. For other reason, judged not appropriate for participation in this study by the principal investigator or investigator.

Primary outcomes:
measure: Change From Baseline in Actigraphy-Measured Sleep Latency at the End of the Treatment Period
timeFrame: Baseline and the end of the Treatment Period (up to Week 8)
Secondary outcomes:
measure: Change From Baseline in Diary-Measured Sleep Latency at the End of the Treatment Period
timeFrame: Baseline and the end of the Treatment Period (up to Week 8)
measure: Change From Baseline in Actigraphy-Measured Total Nocturnal Sleep Time at the End of the Treatment Period
timeFrame: Baseline and the end of the Treatment Period (up to Week 8)
measure: Change From Baseline in Actigraphy-Measured Nocturnal Wake Time at the End of the Treatment Period
timeFrame: Baseline and the end of the Treatment Period (up to Week 8)
measure: Change From Baseline in Actigraphy-Measured Number of Nocturnal Awakenings at the End of the Treatment Period
timeFrame: Baseline and the end of the Treatment Period (up to Week 8)
measure: Change From Baseline in Actigraphy-Measured Sleep Efficiency at the End of the Treatment Period
timeFrame: Baseline and the end of the Treatment Period (up to Week 8)
measure: Change From Baseline in Diary-Measured Total Nocturnal Sleep Time at the End of the Treatment Period
timeFrame: Baseline and the end of the Treatment Period (up to Week 8)
measure: Change From Baseline in Diary-Measured Number of Nocturnal Awakenings at the End of the Treatment Period
timeFrame: Baseline and the end of the Treatment Period (up to Week 8)
measure: Change From Baseline in Actigraphy-Measured Daytime Activity Level, as Evaluated by the Number of Footsteps, at the End of the Treatment Period
timeFrame: Baseline and the end of the Treatment Period (up to Week 8)
Other outcomes:
Locations:
city: Kitakyushu
country: Japan
facility: You Ariyoshi Sleep Clinic
state: Fukuoka
city: Sapporo
country: Japan
facility: Ishikawa Mental Clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Minami 1jo Mental Clinic
state: Hokkaido
city: Meguro
country: Japan
facility: Senzoku Psychosomatic Clinic
state: Tokyo
city: Setagaya
country: Japan
facility: Sangenjaya Neurology and Psychosomatic Clinic
state: Tokyo
city: Shinjuku
country: Japan
facility: Himorogi Kokorono Clinic
state: Tokyo
city: Shinjuku
country: Japan
facility: Seiwa Hospital
state: Tokyo
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: