Trial Outcomes & Findings for The Exploratory Study to Investigate the Effect of Ramelteon for Insomnia Patients With Major Depressive Disorder by Using Actigraphy (NCT NCT02669082)
NCT ID: NCT02669082
Last Updated: 2019-07-22
Results Overview
Sleep latency was defined as time period measured from "lights out," or bedtime, to the beginning of sleep. Sleep latency was assessed by actigraphy, a non-intrusive tool that measures an individual's movement during sleep. Mean value from the past 7 days was evaluated. A negative change from Baseline indicates improvement.
COMPLETED
PHASE4
26 participants
Baseline and the end of the Treatment Period (up to Week 8)
2019-07-22
Participant Flow
Participants took part in the study at 7 investigative sites in Japan from 09 May 2017 to 31 January 2018.
Participants with a diagnosis of Major Depressive Disorder (MDD) with Insomnia were enrolled in 1 treatment arm: Ramelteon 8 mg.
Participant milestones
| Measure |
Ramelteon 8 mg
Ramelteon 8 mg, tablet, orally, once daily at bedtime for 8 weeks.
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Ramelteon 8 mg
Ramelteon 8 mg, tablet, orally, once daily at bedtime for 8 weeks.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ramelteon 8 mg
n=26 Participants
Ramelteon 8 mg, tablet, orally, once daily at bedtime for 8 weeks.
|
|---|---|
|
Age, Continuous
|
36.9 years
STANDARD_DEVIATION 8.04 • n=26 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=26 Participants
|
|
Region of Enrollment
Japan
|
26 Participants
n=26 Participants
|
|
Height
|
168.7 cm
STANDARD_DEVIATION 8.53 • n=26 Participants
|
|
Weight
|
71.08 kg
STANDARD_DEVIATION 12.548 • n=26 Participants
|
|
Body Mass Index (BMI)
|
24.94 kg/m^2
STANDARD_DEVIATION 3.888 • n=26 Participants
|
|
Smoking Classification
Non-smoking
|
15 Participants
n=26 Participants
|
|
Smoking Classification
Less than 20 Cigarettes per day
|
11 Participants
n=26 Participants
|
|
Alcohol Consumption Per Week
0 day
|
13 Participants
n=26 Participants
|
|
Alcohol Consumption Per Week
1 to 2 days
|
8 Participants
n=26 Participants
|
|
Alcohol Consumption Per Week
3 to 5 days
|
3 Participants
n=26 Participants
|
|
Alcohol Consumption Per Week
6 to 7 days
|
2 Participants
n=26 Participants
|
|
Duration of Insomnia
|
4.586 years
STANDARD_DEVIATION 5.3492 • n=26 Participants
|
|
Duration of Depression
|
3.622 years
STANDARD_DEVIATION 4.5821 • n=26 Participants
|
|
Sleep Latency by Actigraphy
|
44.81 minutes
STANDARD_DEVIATION 20.290 • n=26 Participants
|
|
Sleep Latency by Sleep Diary
|
51.21 minutes
STANDARD_DEVIATION 51.957 • n=26 Participants
|
|
Total Nocturnal Sleep Time by Actigraphy
|
314.89 minutes
STANDARD_DEVIATION 74.285 • n=26 Participants
|
|
Total Nocturnal Sleep Time by Sleep Diary
|
407.98 minutes
STANDARD_DEVIATION 72.153 • n=26 Participants
|
|
Number of Nocturnal Awakenings by Actigraphy
|
6.05 nocturnal awakenings
STANDARD_DEVIATION 2.623 • n=26 Participants
|
|
Number of Nocturnal Awakenings by Sleep Diary
|
1.87 nocturnal awakenings
STANDARD_DEVIATION 1.079 • n=26 Participants
|
|
Nocturnal Wake Time by Actigraphy
|
95.37 minutes
STANDARD_DEVIATION 57.572 • n=26 Participants
|
|
Sleep Efficiency by Actigraphy
|
67.039 percentage of sleep
STANDARD_DEVIATION 12.0067 • n=26 Participants
|
|
Daytime Activity Level by Actigraphy
|
5815.17 steps
STANDARD_DEVIATION 2826.252 • n=26 Participants
|
PRIMARY outcome
Timeframe: Baseline and the end of the Treatment Period (up to Week 8)Population: Full Analysis Set (FAS) was defined as all participants given at least 1 dose of study drug.
Sleep latency was defined as time period measured from "lights out," or bedtime, to the beginning of sleep. Sleep latency was assessed by actigraphy, a non-intrusive tool that measures an individual's movement during sleep. Mean value from the past 7 days was evaluated. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Ramelteon 8 mg
n=26 Participants
Ramelteon 8 mg, tablet, orally, once daily at bedtime for 8 weeks.
|
|---|---|
|
Change From Baseline in Actigraphy-Measured Sleep Latency at the End of the Treatment Period
|
-6.81 minutes
Standard Deviation 32.498
|
SECONDARY outcome
Timeframe: Baseline and the end of the Treatment Period (up to Week 8)Population: FAS was defined as all participants given at least 1 dose of study drug.
Sleep latency was defined as time period measured from "lights out," or bedtime, to the beginning of sleep. Sleep latency was recorded by the participant in a diary. Mean value from the past 7 days at each timepoint was evaluated. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Ramelteon 8 mg
n=26 Participants
Ramelteon 8 mg, tablet, orally, once daily at bedtime for 8 weeks.
|
|---|---|
|
Change From Baseline in Diary-Measured Sleep Latency at the End of the Treatment Period
|
-11.51 minutes
Standard Deviation 38.087
|
SECONDARY outcome
Timeframe: Baseline and the end of the Treatment Period (up to Week 8)Population: FAS was defined as all participants given at least 1 dose of study drug.
Total nocturnal sleep time was assessed by actigraphy, a non-intrusive tool that measures an individual's movement during sleep. Total nocturnal sleep time by actigraphy was total time in bed from which sleep latency, nocturnal wake time, and the time from waking up to leaving the bed were subtracted. Mean value from the past 7 days at each timepoint was evaluated. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Ramelteon 8 mg
n=26 Participants
Ramelteon 8 mg, tablet, orally, once daily at bedtime for 8 weeks.
|
|---|---|
|
Change From Baseline in Actigraphy-Measured Total Nocturnal Sleep Time at the End of the Treatment Period
|
24.20 minutes
Standard Deviation 87.470
|
SECONDARY outcome
Timeframe: Baseline and the end of the Treatment Period (up to Week 8)Population: FAS was defined as all participants given at least 1 dose of study drug.
Nocturnal wake time is the total time that is scored between nocturnal sleep onset and final wake-up. Nocturnal wake time was assessed by actigraphy, a non-intrusive tool that measures an individual's movement during sleep. Mean value from the past 7 days at each timepoint was evaluated. A positive change from Baseline indicates a worsening.
Outcome measures
| Measure |
Ramelteon 8 mg
n=26 Participants
Ramelteon 8 mg, tablet, orally, once daily at bedtime for 8 weeks.
|
|---|---|
|
Change From Baseline in Actigraphy-Measured Nocturnal Wake Time at the End of the Treatment Period
|
10.07 minutes
Standard Deviation 38.739
|
SECONDARY outcome
Timeframe: Baseline and the end of the Treatment Period (up to Week 8)Population: FAS was defined as all participants given at least 1 dose of study drug.
The number of nocturnal awakenings were assessed by actigraphy which is a non-intrusive tool that measures an individual's movement during sleep. Mean value from the past 7 days at each time point was evaluated. A positive change from Baseline indicates a worsening.
Outcome measures
| Measure |
Ramelteon 8 mg
n=26 Participants
Ramelteon 8 mg, tablet, orally, once daily at bedtime for 8 weeks.
|
|---|---|
|
Change From Baseline in Actigraphy-Measured Number of Nocturnal Awakenings at the End of the Treatment Period
|
0.53 nocturnal awakenings
Standard Deviation 1.338
|
SECONDARY outcome
Timeframe: Baseline and the end of the Treatment Period (up to Week 8)Population: FAS was defined as all participants given at least 1 dose of study drug.
Sleep efficiency was defined as percentage of sleep in the period potentially filled by sleep-ratio of total sleep time to time in bed calculated as \[(Total sleep time/total time in bed) \* 100\]. Sleep efficiency was assessed by actigraphy, a non-intrusive tool that measures an individual's movement during sleep. Mean value from the past 7 days at each timepoint was evaluated. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Ramelteon 8 mg
n=26 Participants
Ramelteon 8 mg, tablet, orally, once daily at bedtime for 8 weeks.
|
|---|---|
|
Change From Baseline in Actigraphy-Measured Sleep Efficiency at the End of the Treatment Period
|
1.831 percentage of sleep
Standard Deviation 11.2028
|
SECONDARY outcome
Timeframe: Baseline and the end of the Treatment Period (up to Week 8)Population: FAS was defined as all participants given at least 1 dose of study drug.
Total nocturnal sleep time by diary was calculated as total time in bed (awaking hour - bedtime hour) from which sleep latency was subtracted. Mean value from the past 7 days at each timepoint was evaluated. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Ramelteon 8 mg
n=26 Participants
Ramelteon 8 mg, tablet, orally, once daily at bedtime for 8 weeks.
|
|---|---|
|
Change From Baseline in Diary-Measured Total Nocturnal Sleep Time at the End of the Treatment Period
|
41.17 minutes
Standard Deviation 85.969
|
SECONDARY outcome
Timeframe: Baseline and the end of the Treatment Period (up to Week 8)Population: FAS was defined as all participants given at least 1 dose of study drug.
The number of nocturnal awakenings were recorded by the participant in a diary. Mean value from the past 7 days at each timepoint was evaluated. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Ramelteon 8 mg
n=26 Participants
Ramelteon 8 mg, tablet, orally, once daily at bedtime for 8 weeks.
|
|---|---|
|
Change From Baseline in Diary-Measured Number of Nocturnal Awakenings at the End of the Treatment Period
|
-0.44 nocturnal awakenings
Standard Deviation 1.046
|
SECONDARY outcome
Timeframe: Baseline and the end of the Treatment Period (up to Week 8)Population: FAS was defined as all participants given at least 1 dose of study drug.
Daytime activity level, as evaluated by the number of footsteps, were assessed by actigraphy, a non-intrusive tool that measures an individual's movement. Mean value from the past 7 days at each timepoint was evaluated. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Ramelteon 8 mg
n=26 Participants
Ramelteon 8 mg, tablet, orally, once daily at bedtime for 8 weeks.
|
|---|---|
|
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 steps
Standard Deviation 2418.187
|
Adverse Events
Ramelteon 8 mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ramelteon 8 mg
n=26 participants at risk
Ramelteon 8 mg, tablet, orally, once daily at bedtime for 8 weeks.
|
|---|---|
|
Infections and infestations
Viral upper respiratory tract infections
|
19.2%
5/26 • Up to Week 8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Somnolence
|
15.4%
4/26 • Up to Week 8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER