Trial Outcomes & Findings for Effects of Eszopiclone on Sleep-dependent Learning in Schizophrenia (NCT NCT00833547)
NCT ID: NCT00833547
Last Updated: 2014-09-09
Results Overview
The finger tapping task involves pressing four numerically labeled keys on a standard computer keyboard with the fingers of the left hand, repeating a five element sequence (4-1-3-2-4) "as quickly and accurately as possible" for 30s. During both training and test sessions, participants alternated tapping and resting for 30s for a total of 12 tapping trials. The measure was the number of correct sequences per trial. Overnight change was the percent change in correct sequences from the last three training trials to the first three test trials the following morning.
COMPLETED
NA
25 participants
Train on Day 3 and Test on Day 4 of study (experimental nights)
2014-09-09
Participant Flow
Participant milestones
| Measure |
Placebo
placebo capsules that appear identical to eszopiclone capsules on 2 consecutive nights
|
Eszopiclone
3mg of eszopiclone at bedtime for two consecutive nights
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
|
Overall Study
COMPLETED
|
11
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Placebo
placebo capsules that appear identical to eszopiclone capsules on 2 consecutive nights
|
Eszopiclone
3mg of eszopiclone at bedtime for two consecutive nights
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
Effects of Eszopiclone on Sleep-dependent Learning in Schizophrenia
Baseline characteristics by cohort
| Measure |
Eszopiclone
n=10 Participants
3mg of eszopiclone at bedtime on 2 consecutive nights
|
Placebo
n=11 Participants
placebo capsule that looks identical to eszopiclone at bedtime on 2 consecutive nights
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35 years
STANDARD_DEVIATION 10 • n=39 Participants
|
34 years
STANDARD_DEVIATION 9 • n=41 Participants
|
34 years
STANDARD_DEVIATION 9 • n=35 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
17 Participants
n=35 Participants
|
|
Overnight change on finger tapping task
|
8 percent change
STANDARD_DEVIATION 19 • n=39 Participants
|
-5 percent change
STANDARD_DEVIATION 25 • n=41 Participants
|
2 percent change
STANDARD_DEVIATION 23 • n=35 Participants
|
|
sleep spindle density
|
1.57 spindles per minute
STANDARD_DEVIATION .56 • n=39 Participants
|
1.08 spindles per minute
STANDARD_DEVIATION .43 • n=41 Participants
|
1.3 spindles per minute
STANDARD_DEVIATION .5 • n=35 Participants
|
PRIMARY outcome
Timeframe: Train on Day 3 and Test on Day 4 of study (experimental nights)The finger tapping task involves pressing four numerically labeled keys on a standard computer keyboard with the fingers of the left hand, repeating a five element sequence (4-1-3-2-4) "as quickly and accurately as possible" for 30s. During both training and test sessions, participants alternated tapping and resting for 30s for a total of 12 tapping trials. The measure was the number of correct sequences per trial. Overnight change was the percent change in correct sequences from the last three training trials to the first three test trials the following morning.
Outcome measures
| Measure |
Eszopiclone
n=10 Participants
3mg of eszopiclone on two consecutive nights
|
Placebo
n=11 Participants
placebo capsule that looks identical to eszopiclone capsule on two consecutive nights
|
|---|---|---|
|
Overnight Change on Finger Tapping Task
|
21 percent change
Standard Deviation 25
|
2 percent change
Standard Deviation 22
|
PRIMARY outcome
Timeframe: during two nights in an inpatient Clinical Research Center2 baseline nights (Days 1 \&2); 2 experimental nights (Days 3 \&4)
Outcome measures
| Measure |
Eszopiclone
n=10 Participants
3mg of eszopiclone on two consecutive nights
|
Placebo
n=11 Participants
placebo capsule that looks identical to eszopiclone capsule on two consecutive nights
|
|---|---|---|
|
Sleep Spindle Density During Stage 2 Sleep as Measured by Polysomnography
|
1.76 spindles per minute during Stage 2 sleep
Standard Deviation .55
|
1.07 spindles per minute during Stage 2 sleep
Standard Deviation .45
|
Adverse Events
Eszopiclone
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place