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| Name | Class |
|---|---|
| Sumitomo Pharma America, Inc. | INDUSTRY |
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Research has established the incidence of insomnia increases with age and the possible causes contributing to sleep problems in the elderly are still being explored and debated. Older adults use a disproportionately large share of sleep aids with non-prescription sleep aid use having increased over the past decade. This study is a double blind safety and effectiveness trial examining the response of eszopiclone co-administered with escitalopram for the treatment of insomnia symptoms in geriatric depressed adults with insomnia symptoms.
This is a double-blind, randomized, placebo-controlled, parallel-group study. There are two groups of subjects with Major Depressive Disorder and insomnia symptoms randomized to treatment either with eszopicone 2mg or placebo daily at bedtime for 14 weeks beginning at visit 2. Also, all subjects receive open label treatment with escitalopram 10 or 20mg daily in the morning. Safety and efficacy is evaluated as well as rating scales and patient sleep diaries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eszopiclone | Experimental | Drug: Eszopiclone 2mg, Drug: Escitalopram 10mg or 20mg |
|
| Placebo | Placebo Comparator | Drug: Placebo, Drug: Escitalopram 10mg or 20mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eszopiclone | Drug | Eszopiclone 2mg daily at bedtime |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in total sleep time from baseline to final visit | from baseline to final visit |
| Measure | Description | Time Frame |
|---|---|---|
| change in sleep latency from baseline to final visit | from baseline to final visit | |
| Change in HAMD from baseline to final visit | from baseline to final visit | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul K Gross | Lehigh Center for Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lehigh Center for Clinical Research | Allentown | Pennsylvania | 18104 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 8, 2014 | |
| Unrelease | Yes | |
| Release | Sep 9, 2014 | |
| Reset | Sep 12, 2014 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 8, 2014 | Yes | |||
| Sep 9, 2014 |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069582 | Eszopiclone |
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
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| Placebo | Drug | Placebo daily at bedtime |
|
|
| Escitalopram | Drug | Escitalopram 10mg or 20mg |
|
| Change in ISI from baseline to final visit |
| baseline to final visit |
| Change in CGI-S, CGI-I from baseline to final visit | baseline to final visit |
| labs (CBC,urinalysis,TSH,Chemprofile,drugscreen),height | visit 1 |
| vitals: BP,pulse,temperature,weight,assess AE's/SAE's | every visit |
| Sep 12, 2014 |
| D001523 |
| Mental Disorders |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D011725 |
| Pyridines |
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |