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| Name | Class |
|---|---|
| Sumitomo Pharma America, Inc. | INDUSTRY |
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The study examined the effects of adding the sleep aid eszopiclone to Lexapro on mood and levels of the neurotransmitters glutamate, glutamine, and GABA in women with depression, anxiety, and insomnia. Specifically, the objective was to determine the role of glutamate, glutamine, and GABA in mediating the response the to the combined treatment. The hypothesis was that levels of glutamine and glutamate will be increased in women receiving eszopiclone compared to those receiving placebo. The antidepressant effect of the medication combination and its effect on sleep status was also assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eszopiclone | Active Comparator | Lexapro for 10 weeks together with eszopiclone. |
|
| Placebo | Placebo Comparator | Lexapro for 10 weeks together with placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eszopiclone | Drug | Subjects receive 10 mg escitalopram daily for four weeks and 10 or 20 mg for an additional six weeks. Subjects also receive 3 mg eszopiclone. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Anterior Cingulate Cortex Glutamine From Baseline to Week 1. | Glutamine levels were measured by single voxel magnetic resonance spectroscopy. In order to normalize the data, the glutamine values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly. | baseline and 1 week |
| Change in Thalamic Glutamine From Baseline to Week 1 | Glutamine levels were measured by single voxel magnetic resonance spectroscopy in the left thalamus. In order to normalize the data, the glutamine values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly. | baseline and 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Anterior Cingulate Cortex Glutamate From Baseline to Week 1 | Glutamate levels were measured in the anterior cingulate cortex using single voxel magnetic resonance spectroscopy. In order to normalize the data, the glutamate values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly. | baseline and 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael E Henry, MD | Steward St. Elizabeth's Medical Center of Boston, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steward St. Elizabeth's Medical Center of Boston, Inc. | Boston | Massachusetts | 02135 | United States |
Enrolled participants were excluded before assignment to groups if they had another co-morbid psychiatric diagnosis, a medical condition that could affect glutamate or GABA levels, a clinical presentation that was not consistent with a diagnosis of major depressive disorder, or rating scale scores below the minimum for inclusion.
The recruitment period was from September 2008 until October 2010. Participants were recruited by advertising in the community.
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| ID | Title | Description |
|---|---|---|
| FG000 | Eszopiclone | Lexapro for 10 weeks together with eszopiclone. |
| FG001 | Placebo | Escitalopram with placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Eszopiclone | Lexapro for 10 weeks together with eszopiclone. |
| BG001 | Placebo | Escitalopram with placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Anterior Cingulate Cortex Glutamine From Baseline to Week 1. | Glutamine levels were measured by single voxel magnetic resonance spectroscopy. In order to normalize the data, the glutamine values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly. | Participants who had usable MRS data from both the baseline and week 1 scans were included in the analysis. Participants whose data was considered unreliable were excluded. | Posted | Mean | Standard Deviation | ratio (glutamine to creatine) | baseline and 1 week |
|
Adverse event data was collected at all study visits which occurred every one to two 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 | Lexapro for 10 weeks together with eszopiclone. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| jaw pain | General disorders | Non-systematic Assessment |
Withdrawal of support by the funding sponsor due to other priorities resulted in a very small sample size with a small placebo group. Participant withdrawal and unusable data explains discrepancies in subject numbers in some analyses.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tara Lauriat, Ph.D. | Steward St. Elizabeth's Medical Center of Boston, Inc. | 617-789-2404 | tara.lauriat@steward.org |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
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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 | Subjects receive 10 mg of escitalopram daily for four weeks followed by 10 or 20 mg for an additional six weeks. Subjects also receive placebo for eszopiclone. |
|
| Change in Thalamic Glutamate From Baseline to Week 1 | Glutamate levels were measured in the left thalamus using single voxel magnetic resonance spectroscopy. In order to normalize the data, the glutamate values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly. | baseline and 1 week |
| Change in Anterior Cingulate Cortex GABA From Baseline to Week 1 | GABA levels were measured in the anterior cingulate cortex using single voxel magnetic resonance spectroscopy. In order to normalize the data, the GABA values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly. | baseline and 1 week |
| Change in Thalamic GABA From Baseline to Week 1 | GABA levels were measured in the left thalamus using single voxel magnetic resonance spectroscopy. In order to normalize the data, the GABA values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly. | baseline and 1 week |
| Change in Hamilton Depression Rating Scale Score From Baseline to Week 10 | The Hamilton Depression Rating Scale is a 21 item scale that assesses symptoms of depression with items rated on a scale of 0-4 or 0-2. The total score range is 0 to 65. A score of 7 or lower is generally considered to be an absence of depressive symptoms. A score of 18 was considered to be the cut-off for enrollment in this study, as this indicates clinically significant depression. A higher score represents greater severity of depressive symptoms. | baseline and 10 weeks |
| Change in Hamilton Anxiety Rating Scale Score From Baseline to Week 10 | The Hamilton Anxiety Rating Scale is a 14 item ordinal scale that assesses symptoms of anxiety with ratings from 0-4. The score range is 0 to 56, with a higher score indicating higher levels of anxiety. A score of 15 was designated as the cut-off for enrollment in the study. | baseline and 10 weeks |
| Change in Insomnia Severity Index Score From Baseline to Week 10 | The Insomnia Severity Index is a 7 item scale that assesses difficulty sleeping and effect on quality of life with item scores from 0-4. The total score range is 0 to 28 with higher scores indicating higher levels of impairment and distress. | baseline and 10 weeks |
| Withdrawal by Subject |
|
| Physician Decision |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Open label escitalopram for 10 weeks together with placebo for 10 weeks. |
|
|
|
| Primary | Change in Thalamic Glutamine From Baseline to Week 1 | Glutamine levels were measured by single voxel magnetic resonance spectroscopy in the left thalamus. In order to normalize the data, the glutamine values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly. | Participants were included in the analysis if they had usable spectroscopy data from baseline and week 1 and were not considered to have any confounding issues such as an abnormal structural MRI. | Posted | Mean | Standard Deviation | ratio (glutamine to creatine) | baseline and 1 week |
|
|
|
|
| Secondary | Change in Anterior Cingulate Cortex Glutamate From Baseline to Week 1 | Glutamate levels were measured in the anterior cingulate cortex using single voxel magnetic resonance spectroscopy. In order to normalize the data, the glutamate values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly. | Posted | Mean | Standard Deviation | ratio (glutamate to creatine) | baseline and 1 week |
|
|
|
|
| Secondary | Change in Thalamic Glutamate From Baseline to Week 1 | Glutamate levels were measured in the left thalamus using single voxel magnetic resonance spectroscopy. In order to normalize the data, the glutamate values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly. | Posted | Mean | Standard Deviation | ratio (glutamate to creatine) | baseline and 1 week |
|
|
|
|
| Secondary | Change in Anterior Cingulate Cortex GABA From Baseline to Week 1 | GABA levels were measured in the anterior cingulate cortex using single voxel magnetic resonance spectroscopy. In order to normalize the data, the GABA values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly. | Posted | Mean | Standard Deviation | ratio (GABA to creatine) | baseline and 1 week |
|
|
|
|
| Secondary | Change in Thalamic GABA From Baseline to Week 1 | GABA levels were measured in the left thalamus using single voxel magnetic resonance spectroscopy. In order to normalize the data, the GABA values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly. | Posted | Mean | Standard Deviation | ratio (GABA to creatine) | baseline and 1 week |
|
|
|
|
| Secondary | Change in Hamilton Depression Rating Scale Score From Baseline to Week 10 | The Hamilton Depression Rating Scale is a 21 item scale that assesses symptoms of depression with items rated on a scale of 0-4 or 0-2. The total score range is 0 to 65. A score of 7 or lower is generally considered to be an absence of depressive symptoms. A score of 18 was considered to be the cut-off for enrollment in this study, as this indicates clinically significant depression. A higher score represents greater severity of depressive symptoms. | Posted | Mean | Standard Deviation | scores on a scale | baseline and 10 weeks |
|
|
|
|
| Secondary | Change in Hamilton Anxiety Rating Scale Score From Baseline to Week 10 | The Hamilton Anxiety Rating Scale is a 14 item ordinal scale that assesses symptoms of anxiety with ratings from 0-4. The score range is 0 to 56, with a higher score indicating higher levels of anxiety. A score of 15 was designated as the cut-off for enrollment in the study. | Participants who completed 10 weeks and one participant who completed 6 weeks (using last observation carried forward) were included in this analysis. | Posted | Mean | Standard Deviation | scores on a scale | baseline and 10 weeks |
|
|
|
|
| Secondary | Change in Insomnia Severity Index Score From Baseline to Week 10 | The Insomnia Severity Index is a 7 item scale that assesses difficulty sleeping and effect on quality of life with item scores from 0-4. The total score range is 0 to 28 with higher scores indicating higher levels of impairment and distress. | Posted | Mean | Standard Deviation | scores on a scale | baseline and 10 weeks |
|
|
|
|
| 0 |
| 14 |
| 3 |
| 14 |
| EG001 | Placebo | Escitalopram with placebo | 0 | 5 | 1 | 5 |
| somnolescence | General disorders | Non-systematic Assessment |
|
| MRI abnormality | Nervous system disorders | Non-systematic Assessment |
|
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D011725 |
| Pyridines |