Effects of Eszopiclone on Sleep-dependent Learning in Schizophrenia

NCT00833547 | Completed Results

• 1 other identifier: Sepracor051
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

sleep; schizophrenia; procedural learning; motor skill

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Eszopiclone

EXPERIMENTAL

3mg of eszopiclone on two consecutive nights

Drug: eszopiclone

placebo

PLACEBO COMPARATOR

placebo capsule that looks identical to eszopiclone capsule on two consecutive nights

Drug: placebo

Interventions

eszopiclone DRUG

3 mg of eszopiclone at bedtime on two consecutive nights

Also known as: Lunesta

Eszopiclone

placebo DRUG

Placebo capsules looking identical to eszopiclone at bedtime on two consecutive nights

placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinically stable outpatients with DSM-IV diagnoses of Schizophrenia

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Sumitomo Pharma America, Inc.: collaborator
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (1)

Mass General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Eszopiclone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Pyridines

Results Point of Contact

• Title: Dr. Dara Manoach
• Organization: Massachusetts General Hospital

dara@nmr.mgh.harvard.edu

617-726-6148

Study Officials

• Dara S. Manoach, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychology, Dept. of Psychiatry

Study Record Dates

• First Submitted: January 29, 2009
• First Posted: February 2, 2009
• Study Start: September 1, 2006
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: September 9, 2014
• Results First Posted: September 9, 2014

Record last verified: 2014-08

Locations

US (1)