Schizophrenia
Conditions
Keywords
sleep, schizophrenia, procedural learning, motor skill
Brief summary
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.
Interventions
DRUGeszopiclone
3 mg of eszopiclone at bedtime on two consecutive nights
DRUGplacebo
Placebo capsules looking identical to eszopiclone at bedtime on two consecutive nights
Sponsors
Sumitomo Pharma America, Inc.
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Clinically stable outpatients with DSM-IV diagnoses of Schizophrenia
Exclusion criteria
* History of neurologic or psychiatric disease other than schizophrenia * Substance abuse or dependence within the past six months * Other chronic medical conditions that affect sleep * Pregnancy/breast feeding * Hepatic impairment * Treatment with metabolic inhibitors or inducers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overnight Change on Finger Tapping Task | 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. |
| Sleep Spindle Density During Stage 2 Sleep as Measured by Polysomnography | during two nights in an inpatient Clinical Research Center | 2 baseline nights (Days 1 &2); 2 experimental nights (Days 3 &4) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Eszopiclone 3mg of eszopiclone at bedtime on 2 consecutive nights | 10 |
| Placebo placebo capsule that looks identical to eszopiclone at bedtime on 2 consecutive nights | 11 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Total | Eszopiclone | Placebo |
|---|---|---|---|
| Age, Continuous | 34 years STANDARD_DEVIATION 9 | 35 years STANDARD_DEVIATION 10 | 34 years STANDARD_DEVIATION 9 |
| Overnight change on finger tapping task | 2 percent change STANDARD_DEVIATION 23 | 8 percent change STANDARD_DEVIATION 19 | -5 percent change STANDARD_DEVIATION 25 |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 1 Participants |
| Sex: Female, Male Male | 17 Participants | 7 Participants | 10 Participants |
| sleep spindle density | 1.3 spindles per minute STANDARD_DEVIATION 0.5 | 1.57 spindles per minute STANDARD_DEVIATION 0.56 | 1.08 spindles per minute STANDARD_DEVIATION 0.43 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 11 |
| serious Total, serious adverse events | 0 / 10 | 0 / 11 |
Outcome results
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.
Time frame: Train on Day 3 and Test on Day 4 of study (experimental nights)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eszopiclone | Overnight Change on Finger Tapping Task | 21 percent change | Standard Deviation 25 |
| Placebo | Overnight Change on Finger Tapping Task | 2 percent change | Standard Deviation 22 |
Primary
Sleep Spindle Density During Stage 2 Sleep as Measured by Polysomnography
2 baseline nights (Days 1 &2); 2 experimental nights (Days 3 &4)
Time frame: during two nights in an inpatient Clinical Research Center
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eszopiclone | Sleep Spindle Density During Stage 2 Sleep as Measured by Polysomnography | 1.76 spindles per minute during Stage 2 sleep | Standard Deviation 0.55 |
| Placebo | Sleep Spindle Density During Stage 2 Sleep as Measured by Polysomnography | 1.07 spindles per minute during Stage 2 sleep | Standard Deviation 0.45 |