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Trial record 60 of 3310 for:    schizophrenia

Effects of Eszopiclone on Sleep and Memory in Schizophrenia

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ClinicalTrials.gov Identifier: NCT01641900
Recruitment Status : Completed
First Posted : July 17, 2012
Results First Posted : May 16, 2017
Last Update Posted : June 14, 2017
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Mclean Hospital
Information provided by (Responsible Party):
Dara S. Manoach, PhD, Massachusetts General Hospital

Brief Summary:
The investigators will test the hypothesis that the sleep medication, eszopiclone, can normalize brain activity during sleep and improve memory in patients with schizophrenia. The investigators will do this by measuring sleep and memory performance on two conditions separated by one week: taking 3 mg of eszopiclone and taking placebo. The investigators will study healthy subjects and chronic, medicated outpatients with schizophrenia.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: eszopiclone Drug: placebo Not Applicable

Detailed Description:
Sleep spindles, a defining oscillation of stage 2 non-rapid eye movement sleep (N2), are strongly linked to memory and IQ in healthy individuals. Schizophrenia is characterized by a spindle deficit that correlates with deficient sleep-dependent memory consolidation, symptom severity, IQ and executive function. In a small pilot study of schizophrenia patients, eszopiclone , significantly increased sleep spindles but its effect on memory was not significant. Here, in a larger double-blind, placebo-controlled, cross-over design study, we investigated whether eszopiclone can both increase spindle density and improve memory consolidation. Chronic, medicated schizophrenia outpatients and demographically-matched healthy control participants were randomly assigned to receive either placebo first or 3mg of eszopiclone first for two consecutive nights with high density polysomnography. Placebo and eszopiclone visits were one week apart. Participants were trained on the Motor Sequence Task (MST) at bedtime of the second night of each visit and tested the following morning to probe sleep-dependent motor memory consolidation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sleep-dependent Memory Processing in Schizophrenia
Study Start Date : July 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory Schizophrenia
Drug Information available for: Eszopiclone

Arm Intervention/treatment
Experimental: Schizophrenia

Outpatients with a Structural Clinical Interview confirmed DSM-IV diagnosis of schizophrenia.

All participants receive two interventions: 3 mg eszopiclone and Placebo Intervention conditions are separated by 1 week.

Drug: eszopiclone
3 mg of eszopiclone for two consecutive nights (Baseline Night and Experimental Night). Sleep spindle density (primary outcome) is measured for both nights. Memory consolidation (secondary outcome) is measured over Experimental Night.
Other Name: Lunesta

Drug: placebo
placebo capsule for two consecutive nights. (Baseline Night and Experimental Night). Sleep spindle density (primary outcome) is measured for both nights. Memory consolidation (secondary outcome) is measured over Experimental Night.

Experimental: Healthy Controls
Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use. All participants receive two interventions: 3 mg eszopiclone and Placebo Intervention conditions are separated by 1 week.
Drug: eszopiclone
3 mg of eszopiclone for two consecutive nights (Baseline Night and Experimental Night). Sleep spindle density (primary outcome) is measured for both nights. Memory consolidation (secondary outcome) is measured over Experimental Night.
Other Name: Lunesta

Drug: placebo
placebo capsule for two consecutive nights. (Baseline Night and Experimental Night). Sleep spindle density (primary outcome) is measured for both nights. Memory consolidation (secondary outcome) is measured over Experimental Night.




Primary Outcome Measures :
  1. Sleep Spindle Density [ Time Frame: Spindles will be averaged for the Baseline (Night 1) and Experimental Nights (Night 2) ]
    This measure is averaged for Baseline and Experimental nights. Sleep spindle density (number/minute) for non-Rapid Eye Movement Stage 2 sleep (N2) detected at channel Cz based on polysomnographic recordings.


Secondary Outcome Measures :
  1. Motor Procedural Memory Performance [ Time Frame: Experimental Night (Night 2) ]
    Overnight performance improvement on the finger tapping motor sequence task (MST).The MST involves pressing four numerically labeled keys on a standard keyboard with the fingers of the left hand, repeating a 5 digit sequence as quickly and accurately as possible for 12 trials at 30 seconds each separated by 30 sec rest periods. Different sequences were employed for the Placebo and Drug visits in a counter-balanced order. MST performance is measured as the number of correctly typed sequences in each trial. The primary outcome measure is overnight improvement calculated as the percent increase in average of correct sequences from the last three training trials to the average of first three test trials. Since the outcome measure is calculated as percent improvement from training to test for each participant, there is no highest or lowest possible score.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • clinically stable outpatients with schizophrenia,
  • proficient in English,
  • able to give informed consent,
  • maintained on a stable dose of atypical antipsychotic medications for at least 6 weeks prior to enrollment.
  • healthy Control participants matched as a group to the patients for age, sex, and parental socioeconomic status.

Exclusion Criteria:

  • Substance abuse or dependence within the past six months;
  • other chronic medical conditions that affect sleep; (- pregnancy/breast feeding;
  • hepatic impairment;
  • treatment with inhibitors or inducers of CYP 3A4 or 2E1 enzymes (which metabolize eszopiclone);
  • a history of head injury resulting in prolonged loss of consciousness or other neurological sequelae; (- mental retardation; (- a diagnosed sleep disorder other than insomnia,
  • neurological disorder; sleep disorder, other than insomnia, identified in a clinical sleep evaluation.

Patients on conventional agents, benzodiazepines, or other sleep agents will be excluded. Potential controls will be excluded for a personal history of mental illness, a family history of schizophrenia spectrum disorder or psychosis, and treatment with medications known to affect sleep or cognition.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01641900


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Mclean Hospital
Investigators
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Principal Investigator: Dara S Manoach, Ph.D. Massachusetts General Hospital

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Responsible Party: Dara S. Manoach, PhD, Professor of Psychology, Dept. of Psychiatry, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01641900     History of Changes
Other Study ID Numbers: R01MH092638 ( U.S. NIH Grant/Contract )
First Posted: July 17, 2012    Key Record Dates
Results First Posted: May 16, 2017
Last Update Posted: June 14, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share IPD data.
Keywords provided by Dara S. Manoach, PhD, Massachusetts General Hospital:
sleep
memory
schizophrenia
eszopiclone
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Eszopiclone
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs