Phase 4
Completed N=26
The Exploratory Study to Investigate the Effect of Ramelteon for Insomnia Patients With Major Depressive Disorder by Using Actigraphy
Source: ClinicalTrials.gov NCT02669082 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcomePrimary: Change From Baseline in Actigraphy-Measured Sleep Latency at the End of the Treatment Period — -6.81 minutes — p=0.2955
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Actigraphy-Measured Sleep Latency at the End of the Treatment Period |
-6.81 | 0.2955 |
| SECONDARY Change From Baseline in Diary-Measured Sleep Latency at the End of the Treatment Period |
-11.51 | 0.1358 |
| SECONDARY Change From Baseline in Actigraphy-Measured Total Nocturnal Sleep Time at the End of the Treatment Period |
24.20 | 0.1706 |
| SECONDARY Change From Baseline in Actigraphy-Measured Nocturnal Wake Time at the End of the Treatment Period |
10.07 | 0.1969 |
| SECONDARY Change From Baseline in Actigraphy-Measured Number of Nocturnal Awakenings at the End of the Treatment Period |
0.53 | 0.0534 |
| SECONDARY Change From Baseline in Actigraphy-Measured Sleep Efficiency at the End of the Treatment Period |
1.831 | 0.4125 |
| SECONDARY Change From Baseline in Diary-Measured Total Nocturnal Sleep Time at the End of the Treatment Period |
41.17 | 0.0220 sig |
| SECONDARY Change From Baseline in Diary-Measured Number of Nocturnal Awakenings at the End of the Treatment Period |
-0.44 | 0.0420 sig |
| SECONDARY Change From Baseline in Actigraphy-Measured Daytime Activity Level, as Evaluated by the Number of Footsteps, at the End of the Treatment Period |
111.11 | 0.8166 |
Eligibility Criteria
Inclusion Criteria
- Has difficulty in initiating sleep at least 3 days per week for at least 4 weeks at the time of informed consent.
- Has Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5)-defined depression.
- Man or woman between 20 and 64 years of age, inclusive, at the time of informed consent.
- Outpatient.
- 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".
- 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.
- Under treatment of the same antidepressant agents on a stable dose for at least 4 weeks before the start of the run-in period.
- 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).
- 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.
- In the opinion of the principal investigator or investigator, is capable of understanding the contents of the study and complying with study requirements.
- Is capable of signing and dating the informed consent form in person before any study procedures.
Exclusion Criteria
- Has a history of hypersensitivity to ramelteon and melatonin.
- Has severe liver disorder.
- Took ramelteon within 4 weeks before the informed consent.
- Using any insomnia medications (including investigational drugs and unapproved drugs) for 2 weeks before the treatment period.
- Shift worker or night worker.
- Has complications of psychiatric or neurological diseases that affect sleep state other than depression.
- 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.
- 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.
- Is participating in any other investigational or post-marketing clinical trial/study.
- For other reason, judged not appropriate for participation in this study by the principal investigator or investigator.
Data sourced from ClinicalTrials.gov (NCT02669082). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.