Trial Outcomes & Findings for Efficacy and Safety Study of Org 50081 (Esmirtazapine) in Elderly Participants (P05709) (NCT NCT00561821)
NCT ID: NCT00561821
Last Updated: 2018-10-03
Results Overview
Wake time after sleep onset (WASO) is the total time awake between sleep onset and "lights on"; i.e. from the onset of persistent sleep until the end of the 8-hour polysomnography (PSG) recording. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged.
COMPLETED
PHASE3
538 participants
Up to Day 16
2018-10-03
Participant Flow
Participant milestones
| Measure |
Esmirtazapine 0.5 mg
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 1.5 mg
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 3.0 mg
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Placebo
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
132
|
136
|
134
|
136
|
|
Overall Study
Treated
|
132
|
136
|
133
|
136
|
|
Overall Study
COMPLETED
|
127
|
130
|
132
|
133
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
2
|
3
|
Reasons for withdrawal
| Measure |
Esmirtazapine 0.5 mg
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 1.5 mg
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 3.0 mg
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Placebo
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
|
|---|---|---|---|---|
|
Overall Study
Not treated
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
2
|
|
Overall Study
Reasons not related to trial
|
2
|
1
|
0
|
0
|
|
Overall Study
Other (reason not specified)
|
1
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
2
|
3
|
1
|
1
|
Baseline Characteristics
Efficacy and Safety Study of Org 50081 (Esmirtazapine) in Elderly Participants (P05709)
Baseline characteristics by cohort
| Measure |
Esmirtazapine 0.5 mg
n=132 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 1.5 mg
n=136 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 3.0 mg
n=133 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Placebo
n=136 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
|
Total
n=537 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
70.1 Years
STANDARD_DEVIATION 4.4 • n=5 Participants
|
70.0 Years
STANDARD_DEVIATION 4.4 • n=7 Participants
|
71.1 Years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
70.3 Years
STANDARD_DEVIATION 4.3 • n=4 Participants
|
70.4 Years
STANDARD_DEVIATION 4.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
336 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
201 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to Day 16Population: The intent to treat (ITT) population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.
Wake time after sleep onset (WASO) is the total time awake between sleep onset and "lights on"; i.e. from the onset of persistent sleep until the end of the 8-hour polysomnography (PSG) recording. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged.
Outcome measures
| Measure |
Esmirtazapine 0.5 mg
n=129 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 1.5 mg
n=132 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 3.0 mg
n=131 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Placebo
n=133 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
|
|---|---|---|---|---|
|
Average Wake Time After Sleep Onset Measured by Polysomnography
|
80.3 Minutes
Standard Deviation 36.5
|
79.6 Minutes
Standard Deviation 30.7
|
74.8 Minutes
Standard Deviation 28.0
|
109.8 Minutes
Standard Deviation 42.1
|
SECONDARY outcome
Timeframe: Up to Day 16Population: The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.
Latency to Persistent Sleep (LPS) is the time from lights out to the first 20 consecutive epochs scored as sleep by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of LPS (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged.
Outcome measures
| Measure |
Esmirtazapine 0.5 mg
n=129 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 1.5 mg
n=132 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 3.0 mg
n=131 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Placebo
n=133 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
|
|---|---|---|---|---|
|
Average Latency to Persistent Sleep Measured by Polysomnography
|
32.3 Minutes
Standard Deviation 24.8
|
30.7 Minutes
Standard Deviation 23.0
|
29.3 Minutes
Standard Deviation 22.8
|
37.1 Minutes
Standard Deviation 25.7
|
SECONDARY outcome
Timeframe: Up to Day 16Population: The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.
Total sleep time (TST) is the sleep time recorded by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of TST (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged.
Outcome measures
| Measure |
Esmirtazapine 0.5 mg
n=129 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 1.5 mg
n=132 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 3.0 mg
n=131 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Placebo
n=133 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
|
|---|---|---|---|---|
|
Average Total Sleep Time Measured by Polysomnography
|
374.1 Minutes
Standard Deviation 39.9
|
376.2 Minutes
Standard Deviation 34.9
|
383.4 Minutes
Standard Deviation 35.7
|
338.7 Minutes
Standard Deviation 45.8
|
SECONDARY outcome
Timeframe: Up to Day 16Population: The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.
Number of awakenings (NAW) was measured by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of NAW (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged.
Outcome measures
| Measure |
Esmirtazapine 0.5 mg
n=129 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 1.5 mg
n=132 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 3.0 mg
n=131 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Placebo
n=133 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
|
|---|---|---|---|---|
|
Average Number of Awakenings Measured by Polysomnography
|
13.5 Number of awakenings
Standard Deviation 5.4
|
13.4 Number of awakenings
Standard Deviation 4.7
|
13.5 Number of awakenings
Standard Deviation 4.7
|
12.1 Number of awakenings
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: Up to Day 16Population: The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.
Wake time after sleep onset (WASO) is the total time awake between sleep onset and "lights on"; i.e. from the onset of persistent sleep until the end of the 8-hour PSG recording. WASO was recorded in the first quarter of the night, for at most 2 hours, by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged.
Outcome measures
| Measure |
Esmirtazapine 0.5 mg
n=129 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 1.5 mg
n=132 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 3.0 mg
n=131 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Placebo
n=133 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
|
|---|---|---|---|---|
|
Average Wake Time After Sleep Onset in the First Quarter of the Night Measured by Polysomnography
|
34.5 Minutes
Standard Deviation 17.4
|
33.7 Minutes
Standard Deviation 16.2
|
31.2 Minutes
Standard Deviation 15.6
|
40.6 Minutes
Standard Deviation 20.0
|
SECONDARY outcome
Timeframe: Up to Day 16Population: The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.
Wake time after sleep onset (WASO) is the total time awake between sleep onset and "lights on"; i.e. from the onset of persistent sleep until the end of the 8-hour PSG recording. WASO was recorded in the second quarter of the night, for at most 2 hours, by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged.
Outcome measures
| Measure |
Esmirtazapine 0.5 mg
n=129 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 1.5 mg
n=132 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 3.0 mg
n=131 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Placebo
n=133 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
|
|---|---|---|---|---|
|
Average Wake Time After Sleep Onset in the Second Quarter of the Night Measured by Polysomnography
|
20.1 Minutes
Standard Deviation 11.7
|
19.2 Minutes
Standard Deviation 11.4
|
18.9 Minutes
Standard Deviation 10.4
|
25.9 Minutes
Standard Deviation 13.7
|
SECONDARY outcome
Timeframe: Up to Day 16Population: The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.
Wake time after sleep onset (WASO) is the total time awake between sleep onset and "lights on"; i.e. from the onset of persistent sleep until the end of the 8-hour PSG recording. WASO was recorded in the third quarter of the night, for at most 2 hours, by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged.
Outcome measures
| Measure |
Esmirtazapine 0.5 mg
n=129 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 1.5 mg
n=132 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 3.0 mg
n=131 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Placebo
n=133 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
|
|---|---|---|---|---|
|
Average Wake Time After Sleep Onset in the Third Quarter of the Night Measured by Polysomnography
|
20.5 Minutes
Standard Deviation 12.0
|
21.3 Minutes
Standard Deviation 11.6
|
19.1 Minutes
Standard Deviation 10.4
|
31.9 Minutes
Standard Deviation 18.5
|
SECONDARY outcome
Timeframe: Up to Day 16Population: The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.
Wake time after sleep onset (WASO) is the total time awake between sleep onset and "lights on"; i.e. from the onset of persistent sleep until the end of the 8-hour PSG recording. WASO was recorded in the fourth quarter of the night, for at most 2 hours, by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged.
Outcome measures
| Measure |
Esmirtazapine 0.5 mg
n=129 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 1.5 mg
n=132 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 3.0 mg
n=131 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Placebo
n=133 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
|
|---|---|---|---|---|
|
Average Wake Time After Sleep Onset in the Fourth Quarter of the Night Measured by Polysomnography
|
30.9 Minutes
Standard Deviation 17.6
|
29.7 Minutes
Standard Deviation 13.5
|
27.4 Minutes
Standard Deviation 14.9
|
42.4 Minutes
Standard Deviation 23.2
|
SECONDARY outcome
Timeframe: Up to Day 16Population: The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.
Number of stage shifts to stage 1 of sleep or to awaken was measured by PSG. A stage shift is the transition measured by PSG between various sleep stages. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of the number of stage shifts (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged.
Outcome measures
| Measure |
Esmirtazapine 0.5 mg
n=129 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 1.5 mg
n=132 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 3.0 mg
n=131 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Placebo
n=133 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
|
|---|---|---|---|---|
|
Average Number of Stage Shifts to Stage 1 or Wake Measured by Polysomnography
|
51.8 Number of stage shifts
Standard Deviation 16.0
|
50.6 Number of stage shifts
Standard Deviation 15.3
|
51.3 Number of stage shifts
Standard Deviation 16.1
|
44.0 Number of stage shifts
Standard Deviation 15.7
|
SECONDARY outcome
Timeframe: Up to Day 16Population: The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.
Total Sleep Time (TST) is a subjective time (observed data only) recorded daily by the participant in an electronic diary, that was averaged over the entire 16-day, double-blind treatment period.
Outcome measures
| Measure |
Esmirtazapine 0.5 mg
n=129 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 1.5 mg
n=132 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 3.0 mg
n=131 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Placebo
n=132 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
|
|---|---|---|---|---|
|
Average Subjective Total Sleep Time Based on Sleep Diary
|
364.4 Minutes
Standard Deviation 61.4
|
357.3 Minutes
Standard Deviation 73.2
|
368.8 Minutes
Standard Deviation 63.9
|
339.9 Minutes
Standard Deviation 52.7
|
SECONDARY outcome
Timeframe: Up to Day 16Population: The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.
Sleep latency (SL) is the time taken to fall asleep (observed data only) recorded daily by the participant in an electronic diary, that was averaged over the entire 16-day, double-blind treatment period.
Outcome measures
| Measure |
Esmirtazapine 0.5 mg
n=129 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 1.5 mg
n=132 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 3.0 mg
n=131 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Placebo
n=132 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
|
|---|---|---|---|---|
|
Average Subjective Sleep Latency Based on Sleep Diary
|
51.6 Minutes
Standard Deviation 48.9
|
53.1 Minutes
Standard Deviation 39.9
|
50.5 Minutes
Standard Deviation 43.0
|
46.5 Minutes
Standard Deviation 26.3
|
SECONDARY outcome
Timeframe: Up to Day 16Population: The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.
Number of awakenings between sleep onset and final awakening (NAW) is a subjective number (observed data only) recorded daily by the participant in an electronic diary, that was averaged over the entire 16-day, double-blind treatment period.
Outcome measures
| Measure |
Esmirtazapine 0.5 mg
n=129 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 1.5 mg
n=132 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 3.0 mg
n=131 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Placebo
n=132 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
|
|---|---|---|---|---|
|
Average Subjective Number of Awakenings Based on Sleep Diary
|
1.9 Number of Awakenings
Standard Deviation 1.2
|
2.2 Number of Awakenings
Standard Deviation 1.8
|
2.1 Number of Awakenings
Standard Deviation 1.3
|
1.9 Number of Awakenings
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Up to Day 16Population: The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.
Wake Time after Sleep Onset (WASO) is after falling asleep initially, the subjective time that the participant was awake during the night. Daily recordings by the participant in an electronic diary (observed data only), were averaged over the entire 16-day, double-blind treatment period.
Outcome measures
| Measure |
Esmirtazapine 0.5 mg
n=129 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 1.5 mg
n=132 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 3.0 mg
n=131 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Placebo
n=132 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
|
|---|---|---|---|---|
|
Average Subjective Wake Time After Sleep Onset Based on Sleep Diary
|
58.4 Minutes
Standard Deviation 38.9
|
70.3 Minutes
Standard Deviation 53.1
|
62.2 Minutes
Standard Deviation 45.4
|
81.7 Minutes
Standard Deviation 50.0
|
SECONDARY outcome
Timeframe: Up to Day 16Population: The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.
Quality of Sleep (QS) is a subjective number on a Visual Analog Scale ranging from 0 to 100, where very poor is rated at 0, up to excellent, rated at 100. Daily recordings by the participant in an electronic diary (observed data only) were averaged over the entire 16-day, double-blind treatment period.
Outcome measures
| Measure |
Esmirtazapine 0.5 mg
n=129 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 1.5 mg
n=132 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 3.0 mg
n=131 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Placebo
n=132 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
|
|---|---|---|---|---|
|
Average Subjective Quality of Sleep Based on Sleep Diary
|
57.8 Units on a Scale
Standard Deviation 16.1
|
56.7 Units on a Scale
Standard Deviation 17.0
|
58.0 Units on a Scale
Standard Deviation 17.4
|
54.8 Units on a Scale
Standard Deviation 18.1
|
SECONDARY outcome
Timeframe: Up to Day 16Population: The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.
Satisfaction of Sleep Duration (SSD) is a subjective number on a Visual Analog Scale ranging from 0 to 100, where very unsatisfied is rated at 0, up to fully satisfied, rated at 100. Daily recordings by the participant in an electronic diary (observed data only) were averaged over the entire 16-day, double-blind treatment period.
Outcome measures
| Measure |
Esmirtazapine 0.5 mg
n=129 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 1.5 mg
n=132 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 3.0 mg
n=131 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Placebo
n=132 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
|
|---|---|---|---|---|
|
Average Subjective Satisfaction of Sleep Duration Based on Sleep Diary
|
57.8 Units on a Scale
Standard Deviation 16.0
|
56.8 Units on a Scale
Standard Deviation 16.4
|
58.1 Units on a Scale
Standard Deviation 17.2
|
54.0 Units on a Scale
Standard Deviation 17.0
|
SECONDARY outcome
Timeframe: Up to Day 16Population: All participants who received at least one dose of study medication.
An Adverse Event (AE) is any untoward occurrence in a participant who is administered any pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding) symptom, or disease temporarily associated with the use of an investigational medicinal product (IMP), whether or not it is related to the IMP.
Outcome measures
| Measure |
Esmirtazapine 0.5 mg
n=132 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 1.5 mg
n=136 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 3.0 mg
n=133 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Placebo
n=136 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
|
|---|---|---|---|---|
|
Number of Participants With an Adverse Event During the 16 Day, Double-blind Treatment Period
|
48 Number of participants
|
54 Number of participants
|
56 Number of participants
|
40 Number of participants
|
SECONDARY outcome
Timeframe: Up to Day 16Population: All participants who received at least one dose of study medication.
An AE is any untoward occurrence in a participant who is administered any pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding) symptom, or disease temporarily associated with the use of an IMP, whether or not it is related to the IMP.
Outcome measures
| Measure |
Esmirtazapine 0.5 mg
n=132 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 1.5 mg
n=136 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 3.0 mg
n=133 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Placebo
n=136 Participants
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
|
|---|---|---|---|---|
|
Number of Participants Who Discontinued Treatment Due to an Adverse Event During the 16 Day, Double-blind Treatment Period
|
2 Number of participants
|
3 Number of participants
|
1 Number of participants
|
1 Number of participants
|
Adverse Events
Esmirtazapine 0.5 mg
Esmirtazapine 1.5 mg
Esmirtazapine 3.0 mg
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Esmirtazapine 0.5 mg
n=132 participants at risk
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 1.5 mg
n=136 participants at risk
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Esmirtazapine 3.0 mg
n=133 participants at risk
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
|
Placebo
n=136 participants at risk
One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
|
|---|---|---|---|---|
|
General disorders
Fatigue
|
5.3%
7/132 • Number of events 7
Participants who received at least one dose of study medication. One of the 538 enrolled participants was not treated.
|
5.9%
8/136 • Number of events 8
Participants who received at least one dose of study medication. One of the 538 enrolled participants was not treated.
|
6.8%
9/133 • Number of events 9
Participants who received at least one dose of study medication. One of the 538 enrolled participants was not treated.
|
2.2%
3/136 • Number of events 3
Participants who received at least one dose of study medication. One of the 538 enrolled participants was not treated.
|
|
Nervous system disorders
Dizziness
|
6.8%
9/132 • Number of events 9
Participants who received at least one dose of study medication. One of the 538 enrolled participants was not treated.
|
4.4%
6/136 • Number of events 6
Participants who received at least one dose of study medication. One of the 538 enrolled participants was not treated.
|
6.0%
8/133 • Number of events 9
Participants who received at least one dose of study medication. One of the 538 enrolled participants was not treated.
|
2.2%
3/136 • Number of events 3
Participants who received at least one dose of study medication. One of the 538 enrolled participants was not treated.
|
|
Nervous system disorders
Somnolence
|
4.5%
6/132 • Number of events 6
Participants who received at least one dose of study medication. One of the 538 enrolled participants was not treated.
|
8.8%
12/136 • Number of events 13
Participants who received at least one dose of study medication. One of the 538 enrolled participants was not treated.
|
12.0%
16/133 • Number of events 16
Participants who received at least one dose of study medication. One of the 538 enrolled participants was not treated.
|
1.5%
2/136 • Number of events 2
Participants who received at least one dose of study medication. One of the 538 enrolled participants was not treated.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60