N/A
Completed N=59
Effects of Eszopiclone on Sleep and Memory in Schizophrenia
Source: ClinicalTrials.gov NCT01641900 ↗Enrolled (actual)
59
Serious AEs
0.0%
Results posted
May 2017
Primary outcomePrimary: Sleep Spindle Density — 2.02; 2.13; 2.25; 2.44 Sleep spindle density (number/minutes)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sleep Spindle Density |
2.02; 2.13; 2.25; 2.44 | — |
| SECONDARY Motor Procedural Memory Performance |
13.35; 15.1; 9.69; 16.69 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01641900). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.