Trial Outcomes & Findings for Effects of Eszopiclone on Sleep and Memory in Schizophrenia (NCT NCT01641900)
NCT ID: NCT01641900
Last Updated: 2017-06-14
Results Overview
This measure is averaged for Baseline and Experimental nights. Sleep spindle density (number/minute) for non-Rapid Eye Movement Stage 2 sleep (N2) detected at channel Cz based on polysomnographic recordings.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
59 participants
Primary outcome timeframe
Spindles will be averaged for the Baseline (Night 1) and Experimental Nights (Night 2)
Results posted on
2017-06-14
Participant Flow
Participant milestones
| Measure |
Group: Schizophrenia
Outpatients with a Structural Clinical Interview confirmed DSM-IV diagnosis of schizophrenia. Participants completed both the Drug and Placebo arms.
|
Group: Healthy Controls
Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use. Participants completed both the Drug and Placebo arms.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
31
|
|
Overall Study
Completed Placebo Intervention
|
27
|
29
|
|
Overall Study
Completed Drug Intervention
|
26
|
29
|
|
Overall Study
COMPLETED
|
26
|
29
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Group: Schizophrenia
Outpatients with a Structural Clinical Interview confirmed DSM-IV diagnosis of schizophrenia. Participants completed both the Drug and Placebo arms.
|
Group: Healthy Controls
Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use. Participants completed both the Drug and Placebo arms.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
Effects of Eszopiclone on Sleep and Memory in Schizophrenia
Baseline characteristics by cohort
| Measure |
Group: Schizophrenia
n=26 Participants
Outpatients with a Structural Clinical Interview confirmed DSM-IV diagnosis of schizophrenia. Participants completed both the Drug and Placebo arms.
|
Group: Healthy Controls
n=29 Participants
Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use. Participants completed both the Drug and Placebo arms.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
32.3 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
30.1 years
STANDARD_DEVIATION 6.2 • n=7 Participants
|
31.13 years
STANDARD_DEVIATION 6.91 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
29 participants
n=7 Participants
|
55 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Spindles will be averaged for the Baseline (Night 1) and Experimental Nights (Night 2)This measure is averaged for Baseline and Experimental nights. Sleep spindle density (number/minute) for non-Rapid Eye Movement Stage 2 sleep (N2) detected at channel Cz based on polysomnographic recordings.
Outcome measures
| Measure |
Group: Schizophrenia
n=26 Participants
Outpatients with a Structural Clinical Interview confirmed DSM-IV diagnosis of schizophrenia. Participants completed both the Drug and Placebo arms.
|
Group: Healthy Controls
n=29 Participants
Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use. Participants completed both the Drug and Placebo arms.
|
|---|---|---|
|
Sleep Spindle Density
Placebo (placebo capsule)
|
2.02 Sleep spindle density (number/minutes)
Standard Deviation 0.44
|
2.13 Sleep spindle density (number/minutes)
Standard Deviation 0.51
|
|
Sleep Spindle Density
Drug (3mg eszopiclone)
|
2.25 Sleep spindle density (number/minutes)
Standard Deviation 0.41
|
2.44 Sleep spindle density (number/minutes)
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: Experimental Night (Night 2)Overnight performance improvement on the finger tapping motor sequence task (MST).The MST involves pressing four numerically labeled keys on a standard keyboard with the fingers of the left hand, repeating a 5 digit sequence as quickly and accurately as possible for 12 trials at 30 seconds each separated by 30 sec rest periods. Different sequences were employed for the Placebo and Drug visits in a counter-balanced order. MST performance is measured as the number of correctly typed sequences in each trial. The primary outcome measure is overnight improvement calculated as the percent increase in average of correct sequences from the last three training trials to the average of first three test trials. Since the outcome measure is calculated as percent improvement from training to test for each participant, there is no highest or lowest possible score.
Outcome measures
| Measure |
Group: Schizophrenia
n=26 Participants
Outpatients with a Structural Clinical Interview confirmed DSM-IV diagnosis of schizophrenia. Participants completed both the Drug and Placebo arms.
|
Group: Healthy Controls
n=29 Participants
Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use. Participants completed both the Drug and Placebo arms.
|
|---|---|---|
|
Motor Procedural Memory Performance
Placebo (Placebo capsule)
|
13.35 percentage of improvement on MST perform
Standard Deviation 15.62
|
15.1 percentage of improvement on MST perform
Standard Deviation 12.22
|
|
Motor Procedural Memory Performance
Drug (3mg eszopiclone)
|
9.69 percentage of improvement on MST perform
Standard Deviation 17.53
|
16.69 percentage of improvement on MST perform
Standard Deviation 17.14
|
Adverse Events
Placebo With Schizophrenia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Healthy Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3mg Eszopiclone With Schizophrenia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3mg Eszopiclone Healthy Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dara S. Manoach, Principal Investigator
Massachusetts General Hospital
Phone: 617-724-6148
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place