N/A
N=25
Effects of Eszopiclone on Sleep-dependent Learning in Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT00833547 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcome: Primary: Overnight Change on Finger Tapping Task — 21; 2 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- eszopiclone (Drug); placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overnight Change on Finger Tapping Task |
21; 2 | — |
| PRIMARY Sleep Spindle Density During Stage 2 Sleep as Measured by Polysomnography |
1.76; 1.07 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00833547). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.