Effects of Eszopiclone on Sleep-dependent Learning in Schizophrenia
Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: eszopiclone (Drug); placebo (Drug)
Phase: N/A
Status: Completed
Sponsored by: Massachusetts General Hospital Official(s) and/or principal investigator(s): Dara S. Manoach, PhD, Principal Investigator, Affiliation: Massachusetts General Hospital
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.
Clinical Details
Official title: Effects of Eszopiclone on Sleep-dependent Learning in Schizophrenia
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary outcome: Overnight Change on Finger Tapping TaskSleep Spindle Density During Stage 2 Sleep as Measured by Polysomnography
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
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
Locations and Contacts
Mass General Hospital, Boston, Massachusetts 02114, United States
Additional Information
Starting date: September 2006
Last updated: August 26, 2014
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