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

NCT00645944 | Completed Results

• 2 other identifiers: 0702002331ESRC131
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Insomnia; Schizophrenia; Schizoaffective Disorder; Sleep Disorders

Outcome Measures

Primary Outcomes (1)

• Change in Insomnia Severity Index From Baseline.

  The Insomnia Severity Index (ISI) is a 7-item self-report questionnaire that provides a global measure of insomnia severity based on several indicators (e.g., difficulty falling or staying asleep, satisfaction with sleep, degree of impairment with daytime functioning). It has adequate internal consistency (Cronbach's alpha=0.91) and temporal stability (r=0.80), has been validated against sleep diary and polysomnography data and was sensitive to change in several insomnia treatment studies. The ISI scale range is: minimum = 0, maximum = 28. The interpretation is that lower is 'better sleep', while higher is considered 'worse sleep/more insomnia'.

  8 Weeks

Study Arms (2)

Eszopiclone Group

EXPERIMENTAL

Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.

Drug: Eszopiclone

Placebo Group

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Eszopiclone DRUG

Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.

Also known as: Lunesta

Eszopiclone Group

Placebo DRUG

Placebo or inactive substance ("sugar pill")taken each night for all weeks of the study

Placebo Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• Sumitomo Pharma America, Inc.: collaborator

Study Sites (1)

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Schizophrenia; Psychotic Disorders; Sleep Wake Disorders

Interventions

Eszopiclone

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Pyridines

Results Point of Contact

• Title: Cenk Tek, M.D.
• Organization: Yale University

cenk.tek@yale.edu

203-974-7484

Study Officials

• Cenk Tek, M.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 25, 2008
• First Posted: March 28, 2008
• Study Start: April 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: July 16, 2015
• Results First Posted: July 16, 2015

Record last verified: 2015-06

Locations

US (1)