Effects of Eszopiclone on Sleep and Memory in Schizophrenia

NCT01641900 | Completed Results

• 1 other identifier: R01MH092638
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

sleep; memory; schizophrenia; eszopiclone

Outcome Measures

Primary Outcomes (1)

• Sleep Spindle Density

  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.

  Spindles will be averaged for the Baseline (Night 1) and Experimental Nights (Night 2)

Secondary Outcomes (1)

• Motor Procedural Memory Performance

  Experimental Night (Night 2)

Study Arms (2)

Schizophrenia

EXPERIMENTAL

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; Drug: placebo

Healthy Controls

EXPERIMENTAL

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; Drug: placebo

Interventions

eszopiclone DRUG

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.

Also known as: Lunesta

Healthy Controls; Schizophrenia

placebo DRUG

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.

Healthy Controls; Schizophrenia

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Beth Israel Deaconess Medical Center: collaborator
• Mclean Hospital: collaborator

Study Sites (1)

Massachusetts 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: Dara S. Manoach, Principal Investigator
• Organization: Massachusetts General Hospital

dara.manoach@mgh.harvard.edu

617-724-6148

Study Officials

• Dara S Manoach, Ph.D.

  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
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology, Dept. of Psychiatry

Study Record Dates

• First Submitted: January 25, 2012
• First Posted: July 17, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 14, 2017
• Results First Posted: May 16, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)