Back to resultsEffects of Eszopiclone on Sleep and Memory in Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
eszopiclone
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring sleep, memory, schizophrenia, eszopiclone
Eligibility Criteria
Inclusion Criteria:
- clinically stable outpatients with schizophrenia,
- proficient in English,
- able to give informed consent,
- maintained on a stable dose of atypical antipsychotic medications for at least 6 weeks prior to enrollment.
- healthy Control participants matched as a group to the patients for age, sex, and parental socioeconomic status.
Exclusion Criteria:
- Substance abuse or dependence within the past six months;
- other chronic medical conditions that affect sleep; (- pregnancy/breast feeding;
- hepatic impairment;
- treatment with inhibitors or inducers of CYP 3A4 or 2E1 enzymes (which metabolize eszopiclone);
- a history of head injury resulting in prolonged loss of consciousness or other neurological sequelae; (- mental retardation; (- a diagnosed sleep disorder other than insomnia,
- neurological disorder; sleep disorder, other than insomnia, identified in a clinical sleep evaluation.
Patients on conventional agents, benzodiazepines, or other sleep agents will be excluded. Potential controls will be excluded for a personal history of mental illness, a family history of schizophrenia spectrum disorder or psychosis, and treatment with medications known to affect sleep or cognition.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Schizophrenia
Healthy Controls
Arm Description
Outpatients with a Structural Clinical Interview confirmed DSM-IV diagnosis of schizophrenia. All participants receive two interventions: 3 mg eszopiclone and Placebo Intervention conditions are separated by 1 week.
Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use. All participants receive two interventions: 3 mg eszopiclone and Placebo Intervention conditions are separated by 1 week.
Outcomes
Primary Outcome Measures
Sleep Spindle Density
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.
Secondary Outcome Measures
Motor Procedural Memory Performance
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.
Full Information
NCT ID
NCT01641900
First Posted
January 25, 2012
Last Updated
May 16, 2017
Sponsor
Massachusetts General Hospital
Collaborators
Beth Israel Deaconess Medical Center, Mclean Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01641900
Brief Title
Effects of Eszopiclone on Sleep and Memory in Schizophrenia
Official Title
Sleep-dependent Memory Processing in Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Beth Israel Deaconess Medical Center, Mclean Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators will test the hypothesis that the sleep medication, eszopiclone, can normalize brain activity during sleep and improve memory in patients with schizophrenia. The investigators will do this by measuring sleep and memory performance on two conditions separated by one week: taking 3 mg of eszopiclone and taking placebo. The investigators will study healthy subjects and chronic, medicated outpatients with schizophrenia.
Detailed Description
Sleep spindles, a defining oscillation of stage 2 non-rapid eye movement sleep (N2), are strongly linked to memory and IQ in healthy individuals. Schizophrenia is characterized by a spindle deficit that correlates with deficient sleep-dependent memory consolidation, symptom severity, IQ and executive function. In a small pilot study of schizophrenia patients, eszopiclone , significantly increased sleep spindles but its effect on memory was not significant. Here, in a larger double-blind, placebo-controlled, cross-over design study, we investigated whether eszopiclone can both increase spindle density and improve memory consolidation. Chronic, medicated schizophrenia outpatients and demographically-matched healthy control participants were randomly assigned to receive either placebo first or 3mg of eszopiclone first for two consecutive nights with high density polysomnography. Placebo and eszopiclone visits were one week apart. Participants were trained on the Motor Sequence Task (MST) at bedtime of the second night of each visit and tested the following morning to probe sleep-dependent motor memory consolidation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
sleep, memory, schizophrenia, eszopiclone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Schizophrenia
Arm Type
Experimental
Arm Description
Outpatients with a Structural Clinical Interview confirmed DSM-IV diagnosis of schizophrenia.
All participants receive two interventions: 3 mg eszopiclone and Placebo Intervention conditions are separated by 1 week.
Arm Title
Healthy Controls
Arm Type
Experimental
Arm Description
Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use. All participants receive two interventions: 3 mg eszopiclone and Placebo Intervention conditions are separated by 1 week.
Intervention Type
Drug
Intervention Name(s)
eszopiclone
Other Intervention Name(s)
Lunesta
Intervention Description
3 mg of eszopiclone for two consecutive nights (Baseline Night and Experimental Night). Sleep spindle density (primary outcome) is measured for both nights. Memory consolidation (secondary outcome) is measured over Experimental Night.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo capsule for two consecutive nights. (Baseline Night and Experimental Night). Sleep spindle density (primary outcome) is measured for both nights. Memory consolidation (secondary outcome) is measured over Experimental Night.
Primary Outcome Measure Information:
Title
Sleep Spindle Density
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)
Secondary Outcome Measure Information:
Title
Motor Procedural Memory Performance
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
clinically stable outpatients with schizophrenia,
proficient in English,
able to give informed consent,
maintained on a stable dose of atypical antipsychotic medications for at least 6 weeks prior to enrollment.
healthy Control participants matched as a group to the patients for age, sex, and parental socioeconomic status.
Exclusion Criteria:
Substance abuse or dependence within the past six months;
other chronic medical conditions that affect sleep; (- pregnancy/breast feeding;
hepatic impairment;
treatment with inhibitors or inducers of CYP 3A4 or 2E1 enzymes (which metabolize eszopiclone);
a history of head injury resulting in prolonged loss of consciousness or other neurological sequelae; (- mental retardation; (- a diagnosed sleep disorder other than insomnia,
neurological disorder; sleep disorder, other than insomnia, identified in a clinical sleep evaluation.
Patients on conventional agents, benzodiazepines, or other sleep agents will be excluded. Potential controls will be excluded for a personal history of mental illness, a family history of schizophrenia spectrum disorder or psychosis, and treatment with medications known to affect sleep or cognition.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dara S Manoach, Ph.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share IPD data.
Learn more about this trial
Effects of Eszopiclone on Sleep and Memory in Schizophrenia
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