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| ID | Type | Description | Link |
|---|---|---|---|
| ESRC131 |
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| Name | Class |
|---|---|
| Sumitomo Pharma America, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eszopiclone | Drug | Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cenk Tek, M.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Mental Health Center | New Haven | Connecticut | 06519 | United States |
179 outpatients were screened, 44 met initial eligibility criteria. Forty-three consented to participate and 4 were withdrawn prior to randomization. Of the remaining 39, 19 were randomized to placebo and 20 to eszopiclone 3mg. Two participants in the placebo arm and 1 participant in the eszopiclone arm withdrew before receiving study medication
The study was conducted between May 2008 and February 2011 at a community mental health center. Following screening and baseline assessment, eligible patients who continued to meet inclusion criteria were randomly assigned to either placebo or eszopiclone in a 1:1 ratio using a randomization procedure blind to both research team and subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | Eszopiclone Group | Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks. Eszopiclone: Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks. |
| FG001 | Placebo Group | 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. Placebo: Placebo or inactive substance ("sugar pill")taken each night for all weeks of the study |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomized |
|
| ||||||||||||||||||
| Received Medication |
|
Of the remaining 39 randomized, 19 were randomized to placebo and 20 to eszopiclone 3mg. Two participants in the placebo arm and 1 participant in the eszopiclone arm withdrew before receiving study medication
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| ID | Title | Description |
|---|---|---|
| BG000 | Eszopiclone Group | Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks. Eszopiclone: Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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'. | Of 39 eligible participants, 19 were randomized to placebo and 20 to eszopiclone 3mg. Two participants in the placebo arm and 1 participant in the eszopiclone arm withdrew before receiving study medication. 36 participants were included in the modified ITT analysis | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 8 Weeks |
|
8 Weeks
Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Eszopiclone Group | Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks. Eszopiclone: Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unpleasant Taste | General disorders | Systematic Assessment | Participants dropped out of the study due to the unpleasant taste of the intervention/placebo. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sedation/drowsiness | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cenk Tek, M.D. | Yale University | 203-974-7484 | cenk.tek@yale.edu |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069582 | Eszopiclone |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
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| Placebo | Drug | Placebo or inactive substance ("sugar pill")taken each night for all weeks of the study |
|
| NOT COMPLETED |
|
|
| Placebo Group |
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. Placebo: Placebo or inactive substance ("sugar pill")taken each night for all weeks of the study |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 |
| Eszopiclone Group |
Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks. Eszopiclone: Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks. |
| OG001 | Placebo Group | 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. Placebo: Placebo or inactive substance ("sugar pill")taken each night for all weeks of the study |
|
|
|
| 3 |
| 19 |
| 16 |
| 19 |
| EG001 | Placebo Group | 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. Placebo: Placebo or inactive substance ("sugar pill")taken each night for all weeks of the study | 1 | 17 | 13 | 17 |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Memory Problems | Nervous system disorders | Systematic Assessment |
|
| Fatigue/Weakness | General disorders | Systematic Assessment |
|
| Irritability | General disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Excitement/nervousness | Psychiatric disorders | Systematic Assessment |
|
| Malaise | Psychiatric disorders | Systematic Assessment |
|
| Memory Problems | Nervous system disorders | Systematic Assessment |
|
| Delusions | Psychiatric disorders | Systematic Assessment |
|
| Dizziness/faintness | Nervous system disorders | Systematic Assessment |
|
| Vision Blurred | Eye disorders | Systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dry Mouth | General disorders | Systematic Assessment |
|
| Increased Salivation | General disorders | Systematic Assessment |
|
| Unpleasant Taste | General disorders | Systematic Assessment |
|
| Tremor | Nervous system disorders | Systematic Assessment |
|
| Ataxia | Nervous system disorders | Systematic Assessment | Ataxia/impaired coordination |
|
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nausea/Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Stomach/ abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Urination Problems | Renal and urinary disorders | Systematic Assessment |
|
| Libido Decrease | Reproductive system and breast disorders | Systematic Assessment |
|
| Orgasmic Dysfunction | Reproductive system and breast disorders | Systematic Assessment |
|
| Sweating | Skin and subcutaneous tissue disorders | Systematic Assessment | Sweating excessively |
|
| Appetite Decrease | Metabolism and nutrition disorders | Systematic Assessment |
|
| Appetite Increase | Metabolism and nutrition disorders | Systematic Assessment |
|
| Weight Loss | Metabolism and nutrition disorders | Systematic Assessment |
|
| Other | General disorders | Non-systematic Assessment | Other unspecified non-serious adverse events |
|
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| D019967 |
| Schizophrenia Spectrum and Other Psychotic Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011725 |
| Pyridines |