Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Depressive symptoms |
Assessed by scores on the Center for Epidemiologic Studies Depression Scale (CES-D). Scores from 0-60, with higher scores indicating higher levels of depression. |
At 4 weeks weeks after beginning study |
|
Primary |
Depressive symptoms |
Assessed by scores on the Center for Epidemiologic Studies Depression Scale (CES-D). Scores from 0-60, with higher scores indicating higher levels of depression. |
At 8 weeks after beginning study |
|
Primary |
Depressive symptoms |
Assessed by scores on the Center for Epidemiologic Studies Depression Scale (CES-D). Scores from 0-60, with higher scores indicating higher levels of depression. |
At 12 weeks after beginning study |
|
Primary |
Depressive symptoms |
Assessed by scores on the Center for Epidemiologic Studies Depression Scale (CES-D). Scores from 0-60, with higher scores indicating higher levels of depression. |
At 16 weeks after beginning study |
|
Primary |
Depressive symptoms |
Assessed by scores on the Montgomery-Asberg Depression rating Scale (MADRS). The scores range from 0-60, with higher scores indicating higher levels of depression. |
At 4 weeks after beginning study |
|
Primary |
Depressive symptoms |
Assessed by scores on the Montgomery-Asberg Depression rating Scale (MADRS). The scores range from 0-60, with higher scores indicating higher levels of depression. |
At 8 weeks after beginning study |
|
Primary |
Depressive symptoms |
Assessed by scores on the Montgomery-Asberg Depression rating Scale (MADRS). The scores range from 0-60, with higher scores indicating higher levels of depression. |
At 12 weeks after beginning study |
|
Primary |
Depressive symptoms |
Assessed by scores on the Montgomery-Asberg Depression rating Scale (MADRS). The scores range from 0-60, with higher scores indicating higher levels of depression. |
At 16 weeks after beginning study |
|
Primary |
Anxiety symptoms |
Assessed by scores on the Generalized Anxiety Disorder Scale (GAD-7). The scores range from 0-21, with higher scores indicating higher levels of anxiety. |
At 4 weeks after beginning study |
|
Primary |
Anxiety symptoms |
Assessed by scores on the Generalized Anxiety Disorder Scale (GAD-7). The scores range from 0-21, with higher scores indicating higher levels of anxiety. |
At 8 weeks after beginning study |
|
Primary |
Anxiety symptoms |
Assessed by scores on the Generalized Anxiety Disorder Scale (GAD-7). The scores range from 0-21, with higher scores indicating higher levels of anxiety. |
At 12 weeks after beginning study |
|
Primary |
Anxiety symptoms |
Assessed by scores on the Generalized Anxiety Disorder Scale (GAD-7). The scores range from 0-21, with higher scores indicating higher levels of anxiety. |
At 16 weeks after beginning study |
|
Secondary |
Menopause symptoms |
Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms. |
At 4 weeks after beginning study |
|
Secondary |
Menopause symptoms |
Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms. |
At 8 weeks after beginning study |
|
Secondary |
Menopause symptoms |
Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms. |
At 12 weeks after beginning study |
|
Secondary |
Menopause symptoms |
Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms. |
At 16 weeks after beginning study |
|
Secondary |
Total nightly sleep time |
Assessed by an Actigraph 2 monitor |
At 4 weeks after beginning study |
|
Secondary |
Total nightly sleep time |
Assessed by an Actigraph 2 monitor |
At 8 weeks after beginning study |
|
Secondary |
Total nightly sleep time |
Assessed by an Actigraph 2 monitor |
At 12 weeks after beginning study |
|
Secondary |
Total nightly sleep time |
Assessed by an Actigraph 2 monitor |
At 16 weeks after beginning study |
|
Secondary |
Sleep onset latency |
Assessed by an Actigraph 2 monitor |
At 4 weeks after beginning study |
|
Secondary |
Sleep onset latency |
Assessed by an Actigraph 2 monitor |
At 8 weeks after beginning study |
|
Secondary |
Sleep onset latency |
Assessed by an Actigraph 2 monitor |
At 12 weeks after beginning study |
|
Secondary |
Sleep onset latency |
Assessed by an Actigraph 2 monitor |
At 16 weeks after beginning study |
|
Secondary |
Wake after sleep onset |
Assessed by an Actigraph 2 monitor |
At 4 weeks after beginning study |
|
Secondary |
Wake after sleep onset |
Assessed by an Actigraph 2 monitor |
At 8 weeks after beginning study |
|
Secondary |
Wake after sleep onset |
Assessed by an Actigraph 2 monitor |
At 12 weeks after beginning study |
|
Secondary |
Wake after sleep onset |
Assessed by an Actigraph 2 monitor |
At 16 weeks after beginning study |
|