Trial Outcomes & Findings for Antidepressant Response in the Treatment of Depressive Symptoms and Frailty Characteristics in Older Adults (NCT NCT01973283)

NCT ID: NCT01973283

Last Updated: 2021-01-29

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 100 participants
• Primary outcome timeframe: Week 8
• Results posted on: 2021-01-29

Participant Flow

Participant milestones

Measure	Medication Treatment-8 Weeks 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.
Overall Study STARTED	100
Overall Study COMPLETED	96
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Medication Treatment-8 Weeks 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.
Overall Study Lost to Follow-up	4

Baseline Characteristics

Antidepressant Response in the Treatment of Depressive Symptoms and Frailty Characteristics in Older Adults

Baseline characteristics by cohort

Measure	Medication Treatment n=100 Participants 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.
Age, Continuous	70.56 years STANDARD_DEVIATION 7.59 • n=93 Participants
Sex: Female, Male Female	66 Participants n=93 Participants
Sex: Female, Male Male	34 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	88 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	17 Participants n=93 Participants
Race (NIH/OMB) White	68 Participants n=93 Participants
Race (NIH/OMB) More than one race	5 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=93 Participants
Region of Enrollment United States	100 Participants n=93 Participants
Hamilton Rating Scale for Depression (HRSD)	20.32 Score on a scale STANDARD_DEVIATION 5.84 • n=93 Participants

PRIMARY outcome

Timeframe: Week 8

Population: 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.

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.

Outcome measures

Measure	Medication Treatment n=96 Participants 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.	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).
Hamilton Rating Scale for Depression (HRSD)	13.3 score on a scale Standard Deviation 7.90	—

PRIMARY outcome

Timeframe: 6 Months

Population: 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.

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.

Outcome measures

Measure	Medication Treatment n=71 Participants 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.	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).
Hamilton Rating Scale for Depression (HRSD)	12.5 score on a scale Standard Deviation 7.44	—

PRIMARY outcome

Timeframe: 12 Months

Population: 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.

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.

Outcome measures

Measure	Medication Treatment n=60 Participants 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.	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).
Hamilton Depression Rating Scale (HRSD)	13.6 score on a scale Standard Deviation 7.48	—

PRIMARY outcome

Timeframe: Baseline (Week 0)

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.

Outcome measures

Measure	Medication Treatment n=49 Participants 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.	Not/Intermediate Frail n=51 Participants 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).
Hamilton Depression Rating Scale: Stratified by Baseline Frailty	21 score on a scale Standard Deviation 6.61	19.7 score on a scale Standard Deviation 5.73

PRIMARY outcome

Timeframe: Week 8

Population: 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.

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.

Outcome measures

Measure	Medication Treatment n=48 Participants 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.	Not/Intermediate Frail n=48 Participants 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).
Hamilton Depression Rating Scale: Stratified by Baseline Frailty	15.1 score on a scale Standard Deviation 8.23	11.6 score on a scale Standard Deviation 7.21

PRIMARY outcome

Timeframe: Month 6

Population: 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.

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.

Outcome measures

Measure	Medication Treatment n=31 Participants 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.	Not/Intermediate Frail n=40 Participants 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).
Hamilton Depression Rating Scale: Stratified by Baseline Frailty	14.8 score on a scale Standard Deviation 8.65	10.8 score on a scale Standard Deviation 5.85

PRIMARY outcome

Timeframe: Month 12

Population: 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.

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.

Outcome measures

Measure	Medication Treatment n=27 Participants 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.	Not/Intermediate Frail n=33 Participants 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).
Hamilton Depression Rating Scale: Stratified by Baseline Frailty	14.3 score on a scale Standard Deviation 8.21	13.0 score on a scale Standard Deviation 6.91

SECONDARY outcome

Timeframe: Baseline (Week 0)

Population: 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.

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).

Outcome measures

Measure	Medication Treatment n=12 Participants 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.	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).
World Health Organization Disability Assessment 2.0 (36-item)	71.7 score on a scale Standard Deviation 24.8	—

SECONDARY outcome

Timeframe: Week 8

Population: 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.

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).

Outcome measures

Measure	Medication Treatment n=84 Participants 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.	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).
World Health Organization Disability Assessment 2.0 (36-item)	68.7 score on a scale Standard Deviation 21.6	—

SECONDARY outcome

Timeframe: 6 Months

Population: 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.

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).

Outcome measures

Measure	Medication Treatment n=64 Participants 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.	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).
World Health Organization Disability Assessment 2.0 (36-item)	66.7 score on a scale Standard Deviation 20.9	—

SECONDARY outcome

Timeframe: 12 Months

Population: 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.

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).

Outcome measures

Measure	Medication Treatment n=59 Participants 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.	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).
World Health Organization Disability Assessment 2.0 (36-item)	67.8 score on a scale Standard Deviation 20.7	—

SECONDARY outcome

Timeframe: Baseline (Week 0)

Population: 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.

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).

Outcome measures

Measure	Medication Treatment n=7 Participants 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.	Not/Intermediate Frail n=5 Participants 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).
World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty	82.3 score on a scale Standard Deviation 24.1	56.8 score on a scale Standard Deviation 18.8

SECONDARY outcome

Timeframe: Week 8

Population: 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.

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).

Outcome measures

Measure	Medication Treatment n=42 Participants 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.	Not/Intermediate Frail n=42 Participants 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).
World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty	77.9 score on a scale Standard Deviation 22.8	59.4 score on a scale Standard Deviation 15.8

SECONDARY outcome

Timeframe: Month 6

Population: 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.

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).

Outcome measures

Measure	Medication Treatment n=29 Participants 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.	Not/Intermediate Frail n=35 Participants 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).
World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty	77.2 score on a scale Standard Deviation 19.9	58.0 score on a scale Standard Deviation 17.5

SECONDARY outcome

Timeframe: Month 12

Population: 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.

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).

Outcome measures

Measure	Medication Treatment n=27 Participants 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.	Not/Intermediate Frail n=32 Participants 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).
World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty	80.9 score on a scale Standard Deviation 18.1	56.7 score on a scale Standard Deviation 15.8

Adverse Events

Medication Treatment-8 Weeks

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Medication Treatment-8 Weeks n=100 participants at risk 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.
Injury, poisoning and procedural complications Fall	2.0% 2/100 • Number of events 2 • Adverse Events were collected for 12 months

Other adverse events

Adverse event data not reported

Additional Information

Patrick J Brown

New York State Psychiatric Institute

Phone: 646-774-8666

Email: patrick.brown@nyspi.columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place