| Primary | Hamilton Rating Scale for Depression (HRSD) | Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity. | Although 100 patients were assessed at baseline, 4 dropped out during the course of the 8-week trial. This leaves an analyzable sample of 96. | Posted | | Mean | Standard Deviation | score on a scale | | Week 8 | | | | ID | Title | Description |
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| OG000 | Medication Treatment | Participants are treated with a flexible-dose antidepressant medication for a period of 8 weeks. Antidepressant Medication: If patient has a history of non-response or cannot tolerate escitalopram and/or duloxetine, then they will be treated openly with an approved antidepressant. |
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| Primary | Hamilton Rating Scale for Depression (HRSD) | Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity. | Of the initial 100 patients assessed at baseline, 29 participants chose to not continue treatment past 8-weeks. As such, only 71 continued into the 10-month continuation phase of the project. Although these 29 were slightly older than the 71 who continued, they did not differ from those who continued in any other way including depression severity at baseline or 8-week treatment response. Because these 29 opted out of treatment after 8-weeks, only 71 were able to be analyzed at 6-months. | Posted | | Mean | Standard Deviation | score on a scale | | 6 Months | | | | ID | Title | Description |
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| OG000 | Medication Treatment | Participants are treated with a flexible-dose antidepressant medication for a period of 8 weeks. Antidepressant Medication: If patient has a history of non-response or cannot tolerate escitalopram and/or duloxetine, then they will be treated openly with an approved antidepressant. |
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| Primary | Hamilton Depression Rating Scale (HRSD) | Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity. | Of the 71 who continued with treatment past 8-weeks, 11 dropped out between the 6- and 12-month assessment points. As such, 60 patients underwent 12-month assessments and were analyzable at 12-months. | Posted | | Mean | Standard Deviation | score on a scale | | 12 Months | | | | ID | Title | Description |
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| OG000 | Medication Treatment | Participants are treated with a flexible-dose antidepressant medication for a period of 8 weeks. Antidepressant Medication: If patient has a history of non-response or cannot tolerate escitalopram and/or duloxetine, then they will be treated openly with an approved antidepressant. |
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| Primary | Hamilton Depression Rating Scale: Stratified by Baseline Frailty | Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Week 0) | | | | ID | Title | Description |
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| OG000 | Frail | Participants who had 3 or more frailty characteristics (slow gait speed, weak grip strength, low physical activity levels, the presence of fatigue and significant weight loss, all determined using prespecified cut scores) at baseline are categorized as having frailty. | | OG001 | Not/Intermediate Frail | Participants who had 0-2 frailty characteristics (slow gait speed, weak grip strength, low physical activity levels, the presence of fatigue and significant weight loss, all determined using prespecified cut scores) at baseline are categorized as either non-frail (0 characteristics) or intermediate frailty (1-2 characteristics). |
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| Primary | Hamilton Depression Rating Scale: Stratified by Baseline Frailty | Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity. | Although 100 patients were assessed at baseline, 4 dropped out during the course of the 8-week trial. This leaves an analyzable sample of 96. | Posted | | Mean | Standard Deviation | score on a scale | | Week 8 | | | | ID | Title | Description |
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| OG000 | Frail | Participants who had 3 or more frailty characteristics (slow gait speed, weak grip strength, low physical activity levels, the presence of fatigue and significant weight loss, all determined using prespecified cut scores) at baseline are categorized as having frailty. | | OG001 | Not/Intermediate Frail | Participants who had 0-2 frailty characteristics (slow gait speed, weak grip strength, low physical activity levels, the presence of fatigue and significant weight loss, all determined using prespecified cut scores) at baseline are categorized as either non-frail (0 characteristics) or intermediate frailty (1-2 characteristics). |
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| Primary | Hamilton Depression Rating Scale: Stratified by Baseline Frailty | Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity. | Of the initial 100 patients assessed at baseline, 29 participants chose to not continue treatment past 8-weeks. As such, only 71 continued into the 10-month continuation phase of the project. Although these 29 were slightly older than the 71 who continued, they did not differ from those who continued in any other way including depression severity at baseline or 8-week treatment response. Because these 29 opted out of treatment after 8-weeks, only 71 were able to be analyzed at 6-months. | Posted | | Mean | Standard Deviation | score on a scale | | Month 6 | | | | ID | Title | Description |
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| OG000 | Frail | Participants who had 3 or more frailty characteristics (slow gait speed, weak grip strength, low physical activity levels, the presence of fatigue and significant weight loss, all determined using prespecified cut scores) at baseline are categorized as having frailty. | | OG001 | Not/Intermediate Frail | Participants who had 0-2 frailty characteristics (slow gait speed, weak grip strength, low physical activity levels, the presence of fatigue and significant weight loss, all determined using prespecified cut scores) at baseline are categorized as either non-frail (0 characteristics) or intermediate frailty (1-2 characteristics). |
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| Primary | Hamilton Depression Rating Scale: Stratified by Baseline Frailty | Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity. | Of the 71 who continued with treatment past 8-weeks, 11 dropped out between the 6- and 12-month assessment points. As such, 60 patients underwent 12-month assessments and were analyzable at 12-months. | Posted | | Mean | Standard Deviation | score on a scale | | Month 12 | | | | ID | Title | Description |
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| OG000 | Frail | Participants who had 3 or more frailty characteristics (slow gait speed, weak grip strength, low physical activity levels, the presence of fatigue and significant weight loss, all determined using prespecified cut scores) at baseline are categorized as having frailty. | | OG001 | Not/Intermediate Frail | Participants who had 0-2 frailty characteristics (slow gait speed, weak grip strength, low physical activity levels, the presence of fatigue and significant weight loss, all determined using prespecified cut scores) at baseline are categorized as either non-frail (0 characteristics) or intermediate frailty (1-2 characteristics). |
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| Secondary | World Health Organization Disability Assessment 2.0 (36-item) | Assesses the level of functioning of patients, a component of the frailty evaluation. The scores assigned to each of the items: "none" (0), "mild" (1) "moderate" (2), "severe" (3), and "extreme" (4) - are summed. Each of the items is simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations. Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability). | Although 100 subjects enrolled in the study, only 12 subjects completed the baseline WHODAS assessment, so only 12 subjects' data were included in the analysis. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Week 0) | | | | ID | Title | Description |
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| OG000 | Medication Treatment | Participants are treated with a flexible-dose antidepressant medication for a period of 8 weeks. Antidepressant Medication: If patient has a history of non-response or cannot tolerate escitalopram and/or duloxetine, then they will be treated openly with an approved antidepressant. |
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| Secondary | World Health Organization Disability Assessment 2.0 (36-item) | Assesses the level of functioning of patients, a component of the frailty evaluation. Simple: the scores assigned to each of the items - "none" (0), "mild" (1) "moderate" (2), "severe" (3), and "extreme" (4) - are summed. This method is referred to as simple scoring because the scores from each of the items are simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. This approach is practical to use as a hand-scoring approach and may be the method of choice in busy clinical settings or in paper-pencil interview situations. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations. Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability). | Although 100 subjects enrolled in the study, only 84 subjects completed the Week 8 WHODAS assessment, so only 84 subjects' data were included in the analysis. | Posted | | Mean | Standard Deviation | score on a scale | | Week 8 | | | | ID | Title | Description |
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| OG000 | Medication Treatment | Participants are treated with a flexible-dose antidepressant medication for a period of 8 weeks. Antidepressant Medication: If patient has a history of non-response or cannot tolerate escitalopram and/or duloxetine, then they will be treated openly with an approved antidepressant. |
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| Secondary | World Health Organization Disability Assessment 2.0 (36-item) | Assesses the level of functioning of patients, a component of the frailty evaluation. The scores assigned to each of the items: "none" (0), "mild" (1) "moderate" (2), "severe" (3), and "extreme" (4) - are summed. Each of the items is simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations. Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability). | Although 100 subjects enrolled in the study, only 64 subjects completed the Month 6 WHODAS assessment, so only 64 subjects' data were included in the analysis. | Posted | | Mean | Standard Deviation | score on a scale | | 6 Months | | | | ID | Title | Description |
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| OG000 | Medication Treatment | Participants are treated with a flexible-dose antidepressant medication for a period of 8 weeks. Antidepressant Medication: If patient has a history of non-response or cannot tolerate escitalopram and/or duloxetine, then they will be treated openly with an approved antidepressant. |
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| Secondary | World Health Organization Disability Assessment 2.0 (36-item) | Assesses the level of functioning of patients, a component of the frailty evaluation. The scores assigned to each of the items: "none" (0), "mild" (1) "moderate" (2), "severe" (3), and "extreme" (4) - are summed. Each of the items is simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations. Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability). | Although 100 subjects enrolled in the study, only 59 subjects completed the Month 12 WHODAS assessment, so only 59 subjects' data were included in the analysis. | Posted | | Mean | Standard Deviation | score on a scale | | 12 Months | | | | ID | Title | Description |
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| OG000 | Medication Treatment | Participants are treated with a flexible-dose antidepressant medication for a period of 8 weeks. Antidepressant Medication: If patient has a history of non-response or cannot tolerate escitalopram and/or duloxetine, then they will be treated openly with an approved antidepressant. |
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| Secondary | World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty | Assesses the level of functioning of patients, a component of the frailty evaluation. The scores assigned to each of the items: "none" (0), "mild" (1) "moderate" (2), "severe" (3), and "extreme" (4) - are summed. Each of the items is simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations. Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability). | Although 100 subjects enrolled in the study, only 12 subjects completed the baseline WHODAS assessment, so only 12 subjects' data were included in the analysis. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Week 0) | | | | ID | Title | Description |
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| OG000 | Frail | Participants who had 3 or more frailty characteristics (slow gait speed, weak grip strength, low physical activity levels, the presence of fatigue and significant weight loss, all determined using prespecified cut scores) at baseline are categorized as having frailty. | | OG001 | Not/Intermediate Frail | Participants who had 0-2 frailty characteristics (slow gait speed, weak grip strength, low physical activity levels, the presence of fatigue and significant weight loss, all determined using prespecified cut scores) at baseline are categorized as either non-frail (0 characteristics) or intermediate frailty (1-2 characteristics). |
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| Secondary | World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty | Assesses the level of functioning of patients, a component of the frailty evaluation. The scores assigned to each of the items: "none" (0), "mild" (1) "moderate" (2), "severe" (3), and "extreme" (4) - are summed. Each of the items is simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations. Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability). | Although 100 subjects enrolled in the study, only 84 subjects completed the Week 8 WHODAS assessment, so only 84 subjects' data were included in the analysis. | Posted | | Mean | Standard Deviation | score on a scale | | Week 8 | | | | ID | Title | Description |
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| OG000 | Frail | Participants who had 3 or more frailty characteristics (slow gait speed, weak grip strength, low physical activity levels, the presence of fatigue and significant weight loss, all determined using prespecified cut scores) at baseline are categorized as having frailty. | | OG001 | Not/Intermediate Frail | Participants who had 0-2 frailty characteristics (slow gait speed, weak grip strength, low physical activity levels, the presence of fatigue and significant weight loss, all determined using prespecified cut scores) at baseline are categorized as either non-frail (0 characteristics) or intermediate frailty (1-2 characteristics). |
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| Secondary | World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty | Assesses the level of functioning of patients, a component of the frailty evaluation. The scores assigned to each of the items: "none" (0), "mild" (1) "moderate" (2), "severe" (3), and "extreme" (4) - are summed. Each of the items is simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations. Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability). | Although 100 subjects enrolled in the study, only 64 subjects completed the Month 6 WHODAS assessment, so only 64 subjects' data were included in the analysis. | Posted | | Mean | Standard Deviation | score on a scale | | Month 6 | | | | ID | Title | Description |
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| OG000 | Frail | Participants who had 3 or more frailty characteristics (slow gait speed, weak grip strength, low physical activity levels, the presence of fatigue and significant weight loss, all determined using prespecified cut scores) at baseline are categorized as having frailty. | | OG001 | Not/Intermediate Frail | Participants who had 0-2 frailty characteristics (slow gait speed, weak grip strength, low physical activity levels, the presence of fatigue and significant weight loss, all determined using prespecified cut scores) at baseline are categorized as either non-frail (0 characteristics) or intermediate frailty (1-2 characteristics). |
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| Secondary | World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty | Assesses the level of functioning of patients, a component of the frailty evaluation. The scores assigned to each of the items: "none" (0), "mild" (1) "moderate" (2), "severe" (3), and "extreme" (4) - are summed. Each of the items is simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations. Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability). | Although 100 subjects enrolled in the study, only 59 subjects completed the Month 12 WHODAS assessment, so only 59 subjects' data were included in the analysis. | Posted | | Mean | Standard Deviation | score on a scale | | Month 12 | | | | ID | Title | Description |
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| OG000 | Frail | Participants who had 3 or more frailty characteristics (slow gait speed, weak grip strength, low physical activity levels, the presence of fatigue and significant weight loss, all determined using prespecified cut scores) at baseline are categorized as having frailty. | | OG001 | Not/Intermediate Frail | Participants who had 0-2 frailty characteristics (slow gait speed, weak grip strength, low physical activity levels, the presence of fatigue and significant weight loss, all determined using prespecified cut scores) at baseline are categorized as either non-frail (0 characteristics) or intermediate frailty (1-2 characteristics). |
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