Randomized, Controlled, Double Blind Trial of Eszopiclone for Insomnia Associated With Schizophrenia

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Yale University

Status

Completed

Conditions

Sleep Disorders
Schizophrenia
Schizoaffective Disorder
Insomnia

Treatments

Drug: Placebo
Drug: Eszopiclone

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00645944
ESRC131
0702002331

Details and patient eligibility

About

The major goal of this project is to investigate established insomnia treatments in a schizophrenia population to see if the improved sleep leads to overall better quality of life. In addition, we hypothesize that the insomnia treatment may also lead to observed improvements in other symptoms associated with schizophrenia such as cognitive impairments, obesity, and negative symptoms.

Full description

The primary aim of this study is to investigate the clinical efficacy of eszopiclone for the treatment of schizophrenia-related insomnia over 8 weeks. A two-week, single-blind placebo phase followed the double-blind phase to evaluate rebound and withdrawal effects after abrupt discontinuation.

Enrollment

39 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Be between the ages of 18 to 64
  • Meet DSM-IV criteria for schizophrenia or schizoaffective disorder
  • Sleep difficulties at least 2x per week in the preceding month
  • Be on a stable dose of antipsychotic medication
  • Symptomatically stable in the last 2 months
  • English speaking.

Exclusion criteria

  • Meet criteria for current alcohol or other substance dependence
  • A history of dementia, mental retardation or other neurological disorder
  • Not capable of giving informed consent for participation in this study.
  • Ongoing pregnancy
  • Known sensitivity to zopiclone.
  • Insomnia associated with medical disorders likely to impair sleep.
  • Use of any medication that affects sleep/wake function (other than antipsychotic medication), within the past 2 weeks or within a time period that is less than 7 half-lives since last use of the medication.
  • Lack of sleep benefit from previous adequate eszopiclone treatment
  • History of clinically significant hepatic impairment.
  • Subject is taking a potent cytochrome p450 3A4 inhibitor medication (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin, ketoconazole, itraconazole) and is unwilling or it is clinically contraindicated to stop the medication.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

39 participants in 2 patient groups, including a placebo group

Eszopiclone Group
Experimental group
Description:
Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.
Treatment:
Drug: Eszopiclone
Placebo Group
Placebo Comparator group
Description:
Participants assigned to this arm will receive placebo (an inactive substance or a "sugar pill") to be taken each night for all weeks of the study.
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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