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| Name | Class |
|---|---|
| Sumitomo Pharma America, Inc. | INDUSTRY |
| Beth Israel Deaconess Medical Center | OTHER |
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This study will determine whether eszopiclone will normalize sleep patterns and restore sleep-dependent enhancement of motor skill learning in patients with schizophrenia. The investigators will compare subjects taking a placebo to those taking 3 mg of eszopiclone with regard to: sleep architecture and sleep latency as measured by actigraphy and polysomnography and sleep-dependent motor skill learning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eszopiclone | Experimental | 3mg of eszopiclone on two consecutive nights |
|
| placebo | Placebo Comparator | placebo capsule that looks identical to eszopiclone capsule on two consecutive nights |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eszopiclone | Drug | 3 mg of eszopiclone at bedtime on two consecutive nights |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overnight Change on Finger Tapping Task | 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. | Train on Day 3 and Test on Day 4 of study (experimental nights) |
| Sleep Spindle Density During Stage 2 Sleep as Measured by Polysomnography | 2 baseline nights (Days 1 &2); 2 experimental nights (Days 3 &4) | during two nights in an inpatient Clinical Research Center |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dara S. Manoach, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mass General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | placebo capsules that appear identical to eszopiclone capsules on 2 consecutive nights |
| FG001 | Eszopiclone | 3mg of eszopiclone at bedtime for two consecutive nights |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Eszopiclone | 3mg of eszopiclone at bedtime on 2 consecutive nights |
| BG001 | Placebo | placebo capsule that looks identical to eszopiclone at bedtime on 2 consecutive nights |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overnight Change on Finger Tapping Task | 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. | Posted | Mean | Standard Deviation | percent change | Train on Day 3 and Test on Day 4 of study (experimental nights) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Eszopiclone | 3mg of eszopiclone on two consecutive nights |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dara Manoach | Massachusetts General Hospital | 617-726-6148 | dara@nmr.mgh.harvard.edu |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069582 | Eszopiclone |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
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| placebo | Drug | Placebo capsules looking identical to eszopiclone at bedtime on two consecutive nights |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Overnight change on finger tapping task | 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. | Mean | Standard Deviation | percent change |
|
| sleep spindle density | spindles per minute during Stage 2 sleep | Mean | Standard Deviation | spindles per minute |
|
| Placebo |
placebo capsule that looks identical to eszopiclone capsule on two consecutive nights |
|
|
| Primary | Sleep Spindle Density During Stage 2 Sleep as Measured by Polysomnography | 2 baseline nights (Days 1 &2); 2 experimental nights (Days 3 &4) | Posted | Mean | Standard Deviation | spindles per minute during Stage 2 sleep | during two nights in an inpatient Clinical Research Center |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Placebo | placebo capsule that looks identical to eszopiclone capsule on two consecutive nights | 0 | 11 | 0 | 11 |
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| D011725 |
| Pyridines |