Effects of Eszopiclone on Sleep-dependent Learning in Schizophrenia

This study has been completed.
Sponsor:
Collaborators:
Sunovion
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Dara S. Manoach, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00833547
First received: January 29, 2009
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Schizophrenia
Drug: eszopiclone
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Effects of Eszopiclone on Sleep-dependent Learning in Schizophrenia

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Overnight Change on Finger Tapping Task [ Time Frame: Train on Day 3 and Test on Day 4 of study (experimental nights) ] [ Designated as safety issue: No ]
    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 [ Time Frame: during two nights in an inpatient Clinical Research Center ] [ Designated as safety issue: No ]
    2 baseline nights (Days 1 &2); 2 experimental nights (Days 3 &4)


Enrollment: 25
Study Start Date: September 2006
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eszopiclone
3mg of eszopiclone on two consecutive nights
Drug: eszopiclone
3 mg of eszopiclone at bedtime on two consecutive nights
Other Name: Lunesta
Placebo Comparator: placebo
placebo capsule that looks identical to eszopiclone capsule on two consecutive nights
Drug: placebo
Placebo capsules looking identical to eszopiclone at bedtime on two consecutive nights

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00833547

Locations
United States, Massachusetts
Mass General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Sunovion
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Dara S. Manoach, PhD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Dara S. Manoach, PhD, Associate Professor of Psychology, Dept. of Psychiatry, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00833547     History of Changes
Other Study ID Numbers: Sepracor051
Study First Received: January 29, 2009
Results First Received: July 17, 2014
Last Updated: August 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
sleep
schizophrenia
procedural learning
motor skill

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Eszopiclone
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014