Effects of Eszopiclone on Sleep and Memory in Schizophrenia

Schizophrenia Clinical Trial

Official title:

Sleep-dependent Memory Processing in Schizophrenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01641900
• Other study ID #: R01MH092638
• Status: Recruiting
• Phase: N/A
• First received: January 25, 2012
• Last updated: June 1, 2015
• Start date: July 2012
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Massachusetts General Hospital
• Contact: Tessa Vuper, BS
• Phone: 617-726-1908
• Email: tcvuper[@]nmr.mgh.harvard.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 comparing sleep and performance in participants taking eszopiclone to participants taking placebo. The investigators will study healthy subjects and patients with schizophrenia taking atypical antipsychotic medications.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• eszopiclone
3 mg of eszopiclone for two consecutive nights
• placebo
placebo capsule for two consecutive nights

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Beth Israel Deaconess Medical Center, Mclean Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sleep spindles	Measurements of sleep spindle parameters based on polysomnographic recordings	spindles will be averaged over the 2 study nights	No
Secondary	Motor procedural memory performance	Performance on a finger tapping motor sequence task will be assessed.	On each of two study visits, that are separated by one week, participants will spend two consecutive nights in the hospital. Performance will be assesed the morning after the second night of each visit.	No