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Trial record 60 of 3313 for:    schizophrenia

Effects of Eszopiclone on Sleep and Memory in Schizophrenia

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ClinicalTrials.gov Identifier: NCT01641900
Recruitment Status : Completed
First Posted : July 17, 2012
Results First Posted : May 16, 2017
Last Update Posted : June 14, 2017
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Mclean Hospital
Information provided by (Responsible Party):
Dara S. Manoach, PhD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Schizophrenia
Interventions Drug: eszopiclone
Drug: placebo
Enrollment 59
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group: Schizophrenia Group: Healthy Controls
Hide Arm/Group Description Outpatients with a Structural Clinical Interview confirmed DSM-IV diagnosis of schizophrenia. Participants completed both the Drug and Placebo arms. 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.
Period Title: Overall Study
Started 28 31
Completed Placebo Intervention 27 [1] 29 [2]
Completed Drug Intervention 26 [3] 29
Completed 26 29
Not Completed 2 2
Reason Not Completed
Withdrawal by Subject             2             2
[1]
n=1,assigned to placebo intervention first, completed the session and dropped out of the study.
[2]
n=2,both assigned to placebo intervention first, completed the session and dropped out of the study.
[3]
n=1,assigned to drug intervention first, completed the session and dropped out of the study.
Arm/Group Title Group: Schizophrenia Group: Healthy Controls Total
Hide Arm/Group Description Outpatients with a Structural Clinical Interview confirmed DSM-IV diagnosis of schizophrenia. Participants completed both the Drug and Placebo arms. 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 of all reporting groups
Overall Number of Baseline Participants 26 29 55
Hide Baseline Analysis Population Description
All participants completed both the Drug and Placebo arms
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 29 participants 55 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
26
 100.0%
29
 100.0%
55
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 29 participants 55 participants
32.3  (7.5) 30.1  (6.2) 31.13  (6.91)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 29 participants 55 participants
Female
5
  19.2%
8
  27.6%
13
  23.6%
Male
21
  80.8%
21
  72.4%
42
  76.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 29 participants 55 participants
Hispanic or Latino
1
   3.8%
3
  10.3%
4
   7.3%
Not Hispanic or Latino
19
  73.1%
19
  65.5%
38
  69.1%
Unknown or Not Reported
6
  23.1%
7
  24.1%
13
  23.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 29 participants 55 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
  11.5%
3
  10.3%
6
  10.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  23.1%
0
   0.0%
6
  10.9%
White
12
  46.2%
17
  58.6%
29
  52.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
5
  19.2%
9
  31.0%
14
  25.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants 29 participants 55 participants
26 29 55
1.Primary Outcome
Title Sleep Spindle Density
Hide Description 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.
Time Frame Spindles will be averaged for the Baseline (Night 1) and Experimental Nights (Night 2)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group: Schizophrenia Group: Healthy Controls
Hide Arm/Group Description:
Outpatients with a Structural Clinical Interview confirmed DSM-IV diagnosis of schizophrenia. Participants completed both the Drug and Placebo arms.
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 Number of Participants Analyzed 26 29
Mean (Standard Deviation)
Unit of Measure: Sleep spindle density (number/minutes)
Placebo (placebo capsule) 2.02  (0.44) 2.13  (0.51)
Drug (3mg eszopiclone) 2.25  (0.41) 2.44  (0.44)
2.Secondary Outcome
Title Motor Procedural Memory Performance
Hide Description 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.
Time Frame Experimental Night (Night 2)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group: Schizophrenia Group: Healthy Controls
Hide Arm/Group Description:
Outpatients with a Structural Clinical Interview confirmed DSM-IV diagnosis of schizophrenia. Participants completed both the Drug and Placebo arms.
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 Number of Participants Analyzed 26 29
Mean (Standard Deviation)
Unit of Measure: percentage of improvement on MST perform
Placebo (Placebo capsule) 13.35  (15.62) 15.1  (12.22)
Drug (3mg eszopiclone) 9.69  (17.53) 16.69  (17.14)
Time Frame through study completion
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo With Schizophrenia Placebo Healthy Controls 3mg Eszopiclone With Schizophrenia 3mg Eszopiclone Healthy Controls
Hide Arm/Group Description Outpatients with a Structural Clinical Interview confirmed DSM-IV diagnosis of schizophrenia. Participants who completed Placebo Intervention. Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use.Participants who completed Placebo Intervention. Outpatients with a Structural Clinical Interview confirmed DSM-IV diagnosis of schizophrenia. Participants who completed Drug Intervention. Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use.Participants who completed Drug Intervention.
All-Cause Mortality
Placebo With Schizophrenia Placebo Healthy Controls 3mg Eszopiclone With Schizophrenia 3mg Eszopiclone Healthy Controls
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/31 (0.00%)   0/28 (0.00%)   0/31 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo With Schizophrenia Placebo Healthy Controls 3mg Eszopiclone With Schizophrenia 3mg Eszopiclone Healthy Controls
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/31 (0.00%)   0/28 (0.00%)   0/31 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo With Schizophrenia Placebo Healthy Controls 3mg Eszopiclone With Schizophrenia 3mg Eszopiclone Healthy Controls
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/31 (0.00%)   0/28 (0.00%)   0/31 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dara S. Manoach, Principal Investigator
Organization: Massachusetts General Hospital
Phone: 617-724-6148
EMail: dara.manoach@mgh.harvard.edu
Layout table for additonal information
Responsible Party: Dara S. Manoach, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01641900     History of Changes
Other Study ID Numbers: R01MH092638 ( U.S. NIH Grant/Contract )
First Submitted: January 25, 2012
First Posted: July 17, 2012
Results First Submitted: February 24, 2017
Results First Posted: May 16, 2017
Last Update Posted: June 14, 2017