Trial Outcomes & Findings for Comparison of Depression Identification After Acute Coronary Syndrome: Quality of Life and Cost Outcomes (NCT NCT01993017)
NCT ID: NCT01993017
Last Updated: 2023-04-14
Results Overview
Change in QALYs from baseline through 18 months. QALYs are a generic measure of disease burden, including both the quality and the quantity of life lived. One QALY equates to one year in perfect health. To measure change in QALYs, utility scores \[an overall assessment of well-being on a scale from 0 (death) to 1 (perfect health)\], were estimated using the Short Form-6 dimension, with scores derived from responses to the 12-Item Short-Form Health Survey, version 2, at baseline and 6, 12, and 18 months. QALYs for the period from baseline to 18 months were then calculated as the area under the curve by linearly interpolating the utility scores at the 4 assessments. Change in QALYs was then obtained by subtracting the baseline QALY from the observed QALY for an 18-month period, where baseline QALY was calculated under the assumption that the baseline utility score remained constant during the 18-month period.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1501 participants
Primary outcome timeframe
Baseline, 6, 12 and 18 months
Results posted on
2023-04-14
Participant Flow
Recruitment period: November 1, 2013 to March 31, 2017 Recruitment sites: HealthPartners (Minneapolis, Minnesota), Duke University Health System (Durham, North Carolina), Kaiser Permanente Northwest (Portland, Oregon), and New York-Presbyterian/Columbia University Irving Medical Center (New York, New York)
1 participant withdrew consent soon after randomization, and this participant's data was excluded from the study.
Participant milestones
| Measure |
AHA Depression Screen, Notify & Treat
Participants randomized to this arm will complete the Depressive symptom screener (8-item Patient Health Questionnaire, PHQ-8) after randomization. Those with clinically significant score (\>=10) will be offered treatment. Treatment will be delivered according to participant preference, and will be managed according to "stepped care". Stepped care includes, a) participant preference for either brief, type of cognitive behavioral therapy (CBT) called problem-solving therapy (PST), delivered centrally by telephone, or antidepressant medication managed at the local site, or both, or neither, and b) review of progress at approximately 2-month intervals, with "stepping up" of care if sufficient progress is not being realized.
|
Depression Screen & Notify
Participants randomized to this arm will complete the depressive symptom screener (8-item Patient Health Questionnaire, PHQ-8) after randomization. Those with clinically significant score (\>=10) will have a letter sent to their primary care provider about their positive screen for depressive symptoms, with subsequent actions at the provider's discretion.
Standard Care: Participants will receive standard care from either their primary care provider (PCP), or PCP-referred mental health provider in one of the arms, IF depressive symptoms are detected.
Depressive symptom screener: 8-item Patient Health Questionnaire, PHQ-8
|
No Depression Screen
Participants randomized to this arm will not complete a PHQ-8 assessment at randomization, and so will not be screened for depressive symptoms.
No intervention
|
|---|---|---|---|
|
Overall Study
STARTED
|
499
|
501
|
500
|
|
Overall Study
COMPLETED
|
393
|
411
|
421
|
|
Overall Study
NOT COMPLETED
|
106
|
90
|
79
|
Reasons for withdrawal
| Measure |
AHA Depression Screen, Notify & Treat
Participants randomized to this arm will complete the Depressive symptom screener (8-item Patient Health Questionnaire, PHQ-8) after randomization. Those with clinically significant score (\>=10) will be offered treatment. Treatment will be delivered according to participant preference, and will be managed according to "stepped care". Stepped care includes, a) participant preference for either brief, type of cognitive behavioral therapy (CBT) called problem-solving therapy (PST), delivered centrally by telephone, or antidepressant medication managed at the local site, or both, or neither, and b) review of progress at approximately 2-month intervals, with "stepping up" of care if sufficient progress is not being realized.
|
Depression Screen & Notify
Participants randomized to this arm will complete the depressive symptom screener (8-item Patient Health Questionnaire, PHQ-8) after randomization. Those with clinically significant score (\>=10) will have a letter sent to their primary care provider about their positive screen for depressive symptoms, with subsequent actions at the provider's discretion.
Standard Care: Participants will receive standard care from either their primary care provider (PCP), or PCP-referred mental health provider in one of the arms, IF depressive symptoms are detected.
Depressive symptom screener: 8-item Patient Health Questionnaire, PHQ-8
|
No Depression Screen
Participants randomized to this arm will not complete a PHQ-8 assessment at randomization, and so will not be screened for depressive symptoms.
No intervention
|
|---|---|---|---|
|
Overall Study
Death
|
23
|
26
|
18
|
|
Overall Study
Could not be contacted
|
43
|
42
|
38
|
|
Overall Study
Dropped out
|
19
|
6
|
11
|
|
Overall Study
Other reasons
|
17
|
11
|
7
|
|
Overall Study
Ineligible after randomization
|
4
|
5
|
5
|
Baseline Characteristics
PHQ-8 data were not collected at Baseline in the "No Depression Screen" Arm/Group).
Baseline characteristics by cohort
| Measure |
AHA Depression Screen, Notify & Treat
n=499 Participants
Participants randomized to this arm will complete the Depressive symptom screener (8-item Patient Health Questionnaire, PHQ-8) after randomization. Those with clinically significant score (\>=10) will be offered treatment. Treatment will be delivered according to participant preference, and will be managed according to "stepped care". Stepped care includes, a) participant preference for either a type of brief, cognitive behavioral therapy (CBT) called problem solving therapy (PST), delivered centrally by telephone, or antidepressant medication managed at the local site, or both, or neither, and b) review of progress at approximately 2-month intervals, with "stepping up" of care if sufficient progress is not being realized.
|
Depression Screen & Notify
n=501 Participants
Participants randomized to this arm will complete the depressive symptom screener (8-item Patient Health Questionnaire, PHQ-8) after randomization. Those with clinically significant score (\>=10) will have a letter sent to their primary care provider about their positive screen for depressive symptoms, with subsequent actions at the provider's discretion.
Standard Care: Participants will receive standard care from either their primary care provider (PCP), or PCP-referred mental health provider in one of the arms, IF depressive symptoms are detected.
Depressive symptom screener: 8-item Patient Health Questionnaire, PHQ-8
|
No Depression Screen
n=500 Participants
Participants randomized to this arm will not complete a PHQ-8 assessment at randomization, and so will not be screened for depressive symptoms.
No intervention
|
Total
n=1500 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Region of Enrollment
United States
|
499 participants
n=499 Participants
|
501 participants
n=501 Participants
|
500 participants
n=500 Participants
|
1500 participants
n=1500 Participants
|
|
PHQ-8 Score >= 10
|
38 Participants
n=494 Participants • PHQ-8 data were not collected at Baseline in the "No Depression Screen" Arm/Group).
|
33 Participants
n=501 Participants • PHQ-8 data were not collected at Baseline in the "No Depression Screen" Arm/Group).
|
—
|
71 Participants
n=995 Participants • PHQ-8 data were not collected at Baseline in the "No Depression Screen" Arm/Group).
|
|
Age, Continuous
|
66.2 years
STANDARD_DEVIATION 11.3 • n=499 Participants
|
65.8 years
STANDARD_DEVIATION 11.7 • n=501 Participants
|
65.8 years
STANDARD_DEVIATION 11.7 • n=500 Participants
|
65.9 years
STANDARD_DEVIATION 11.5 • n=1500 Participants
|
|
Sex: Female, Male
Female
|
142 Participants
n=499 Participants
|
137 Participants
n=501 Participants
|
145 Participants
n=500 Participants
|
424 Participants
n=1500 Participants
|
|
Sex: Female, Male
Male
|
357 Participants
n=499 Participants
|
364 Participants
n=501 Participants
|
355 Participants
n=500 Participants
|
1076 Participants
n=1500 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
82 Participants
n=499 Participants
|
88 Participants
n=501 Participants
|
74 Participants
n=500 Participants
|
244 Participants
n=1500 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
406 Participants
n=499 Participants
|
402 Participants
n=501 Participants
|
410 Participants
n=500 Participants
|
1218 Participants
n=1500 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=499 Participants
|
11 Participants
n=501 Participants
|
16 Participants
n=500 Participants
|
38 Participants
n=1500 Participants
|
|
Race/Ethnicity, Customized
White
|
353 Participants
n=499 Participants
|
368 Participants
n=501 Participants
|
359 Participants
n=500 Participants
|
1080 Participants
n=1500 Participants
|
|
Race/Ethnicity, Customized
Black
|
47 Participants
n=499 Participants
|
37 Participants
n=501 Participants
|
46 Participants
n=500 Participants
|
130 Participants
n=1500 Participants
|
|
Race/Ethnicity, Customized
Other
|
92 Participants
n=499 Participants
|
82 Participants
n=501 Participants
|
85 Participants
n=500 Participants
|
259 Participants
n=1500 Participants
|
|
Race/Ethnicity, Customized
Refused or unknown
|
7 Participants
n=499 Participants
|
14 Participants
n=501 Participants
|
10 Participants
n=500 Participants
|
31 Participants
n=1500 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6, 12 and 18 monthsChange in QALYs from baseline through 18 months. QALYs are a generic measure of disease burden, including both the quality and the quantity of life lived. One QALY equates to one year in perfect health. To measure change in QALYs, utility scores \[an overall assessment of well-being on a scale from 0 (death) to 1 (perfect health)\], were estimated using the Short Form-6 dimension, with scores derived from responses to the 12-Item Short-Form Health Survey, version 2, at baseline and 6, 12, and 18 months. QALYs for the period from baseline to 18 months were then calculated as the area under the curve by linearly interpolating the utility scores at the 4 assessments. Change in QALYs was then obtained by subtracting the baseline QALY from the observed QALY for an 18-month period, where baseline QALY was calculated under the assumption that the baseline utility score remained constant during the 18-month period.
Outcome measures
| Measure |
AHA Depression Screen, Notify & Treat
n=499 Participants
Participants randomized to this arm will complete the Depressive symptom screener (8-item Patient Health Questionnaire, PHQ-8) after randomization. Those with clinically significant score (\>=10) will be offered treatment. Treatment will be delivered according to participant preference, and will be managed according to "stepped care". Stepped care includes, a) participant preference for either brief, type of cognitive behavioral therapy (CBT) called problem-solving therapy (PST), delivered centrally by telephone, or antidepressant medication managed at the local site, or both, or neither, and b) review of progress at approximately 2-month intervals, with "stepping up" of care if sufficient progress is not being realized.
|
Depression Screen & Notify
n=501 Participants
Participants randomized to this arm will complete the depressive symptom screener (8-item Patient Health Questionnaire, PHQ-8) after randomization. Those with clinically significant score (\>=10) will have a letter sent to their primary care provider about their positive screen for depressive symptoms, with subsequent actions at the provider's discretion.
Standard Care: Participants will receive standard care from either their primary care provider (PCP), or PCP-referred mental health provider in one of the arms, IF depressive symptoms are detected.
Depressive symptom screener: 8-item Patient Health Questionnaire, PHQ-8
|
No Depression Screen
n=500 Participants
Participants randomized to this arm will not complete a PHQ-8 assessment at randomization, and so will not be screened for depressive symptoms.
No intervention
|
|---|---|---|---|
|
Quality-Adjusted Life Years (QALYs)
|
-0.06 quality-adjusted life years (QALYs)
Standard Deviation 0.20
|
-0.06 quality-adjusted life years (QALYs)
Standard Deviation 0.20
|
-0.06 quality-adjusted life years (QALYs)
Standard Deviation 0.18
|
SECONDARY outcome
Timeframe: Baseline through 18 monthsDepression-free days from baseline through 18 months post-randomization
Outcome measures
| Measure |
AHA Depression Screen, Notify & Treat
n=499 Participants
Participants randomized to this arm will complete the Depressive symptom screener (8-item Patient Health Questionnaire, PHQ-8) after randomization. Those with clinically significant score (\>=10) will be offered treatment. Treatment will be delivered according to participant preference, and will be managed according to "stepped care". Stepped care includes, a) participant preference for either brief, type of cognitive behavioral therapy (CBT) called problem-solving therapy (PST), delivered centrally by telephone, or antidepressant medication managed at the local site, or both, or neither, and b) review of progress at approximately 2-month intervals, with "stepping up" of care if sufficient progress is not being realized.
|
Depression Screen & Notify
n=501 Participants
Participants randomized to this arm will complete the depressive symptom screener (8-item Patient Health Questionnaire, PHQ-8) after randomization. Those with clinically significant score (\>=10) will have a letter sent to their primary care provider about their positive screen for depressive symptoms, with subsequent actions at the provider's discretion.
Standard Care: Participants will receive standard care from either their primary care provider (PCP), or PCP-referred mental health provider in one of the arms, IF depressive symptoms are detected.
Depressive symptom screener: 8-item Patient Health Questionnaire, PHQ-8
|
No Depression Screen
n=500 Participants
Participants randomized to this arm will not complete a PHQ-8 assessment at randomization, and so will not be screened for depressive symptoms.
No intervention
|
|---|---|---|---|
|
Depression-free Days
|
343.1 cumulative depression-free days
Standard Deviation 179.0
|
351.3 cumulative depression-free days
Standard Deviation 175.0
|
339.0 cumulative depression-free days
Standard Deviation 176.6
|
SECONDARY outcome
Timeframe: Baseline through 18 monthsTotal cost of health care utilization from baseline through 18 months post-randomization
Outcome measures
| Measure |
AHA Depression Screen, Notify & Treat
n=499 Participants
Participants randomized to this arm will complete the Depressive symptom screener (8-item Patient Health Questionnaire, PHQ-8) after randomization. Those with clinically significant score (\>=10) will be offered treatment. Treatment will be delivered according to participant preference, and will be managed according to "stepped care". Stepped care includes, a) participant preference for either brief, type of cognitive behavioral therapy (CBT) called problem-solving therapy (PST), delivered centrally by telephone, or antidepressant medication managed at the local site, or both, or neither, and b) review of progress at approximately 2-month intervals, with "stepping up" of care if sufficient progress is not being realized.
|
Depression Screen & Notify
n=501 Participants
Participants randomized to this arm will complete the depressive symptom screener (8-item Patient Health Questionnaire, PHQ-8) after randomization. Those with clinically significant score (\>=10) will have a letter sent to their primary care provider about their positive screen for depressive symptoms, with subsequent actions at the provider's discretion.
Standard Care: Participants will receive standard care from either their primary care provider (PCP), or PCP-referred mental health provider in one of the arms, IF depressive symptoms are detected.
Depressive symptom screener: 8-item Patient Health Questionnaire, PHQ-8
|
No Depression Screen
n=500 Participants
Participants randomized to this arm will not complete a PHQ-8 assessment at randomization, and so will not be screened for depressive symptoms.
No intervention
|
|---|---|---|---|
|
Cost of Health Care Utilization
|
6745 US dollars
Standard Error 358
|
6204 US dollars
Standard Error 332
|
7440 US dollars
Standard Error 501
|
Adverse Events
AHA Depression Screen, Notify & Treat
Serious events: 0 serious events
Other events: 386 other events
Deaths: 23 deaths
Depression Screen & Notify
Serious events: 0 serious events
Other events: 398 other events
Deaths: 26 deaths
No Depression Screen
Serious events: 0 serious events
Other events: 399 other events
Deaths: 18 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AHA Depression Screen, Notify & Treat
n=450 participants at risk；n=499 participants at risk
Participants randomized to this arm will complete the Depressive symptom screener (8-item Patient Health Questionnaire, PHQ-8) after randomization. Those with clinically significant score (\>=10) will be offered treatment. Treatment will be delivered according to participant preference, and will be managed according to "stepped care". Stepped care includes, a) participant preference for either brief, type of cognitive behavioral therapy (CBT) called problem-solving therapy (PST), delivered centrally by telephone, or antidepressant medication managed at the local site, or both, or neither, and b) review of progress at approximately 2-month intervals, with "stepping up" of care if sufficient progress is not being realized.
|
Depression Screen & Notify
n=455 participants at risk；n=501 participants at risk
Participants randomized to this arm will complete the depressive symptom screener (8-item Patient Health Questionnaire, PHQ-8) after randomization. Those with clinically significant score (\>=10) will have a letter sent to their primary care provider about their positive screen for depressive symptoms, with subsequent actions at the provider's discretion.
Standard Care: Participants will receive standard care from either their primary care provider (PCP), or PCP-referred mental health provider in one of the arms, IF depressive symptoms are detected.
Depressive symptom screener: 8-item Patient Health Questionnaire, PHQ-8
|
No Depression Screen
n=458 participants at risk；n=500 participants at risk
Participants randomized to this arm will not complete a PHQ-8 assessment at randomization, and so will not be screened for depressive symptoms.
No intervention
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Any bleeding at 6 mo
|
13.6%
61/450 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
11.2%
51/455 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
15.8%
72/457 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
|
Psychiatric disorders
Increased appetite at 6 mo
|
18.4%
83/450 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
18.5%
84/455 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
19.9%
91/457 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
|
Psychiatric disorders
Decreased appetite at 6 mo
|
16.0%
72/450 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
16.3%
74/455 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
16.6%
76/457 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
|
Psychiatric disorders
Drowsiness at 6 mo
|
48.4%
218/450 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
46.6%
212/455 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
47.4%
217/458 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
|
Gastrointestinal disorders
Gastrointestinal upset at 6 mo
|
28.4%
128/450 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
25.6%
116/454 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
24.5%
112/457 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
|
Blood and lymphatic system disorders
Any bleeding at 12 mo
|
12.1%
51/423 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
11.7%
50/429 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
11.7%
50/427 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
|
Psychiatric disorders
Increased appetite at 12 mo
|
16.8%
71/423 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
17.9%
77/431 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
17.8%
76/427 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
|
Psychiatric disorders
Decreased appetite at 12 mo
|
14.9%
63/423 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
15.1%
65/431 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
17.8%
76/427 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
|
Psychiatric disorders
Drowsiness at 12 mo
|
42.3%
179/423 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
43.4%
187/431 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
46.4%
198/427 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
|
Gastrointestinal disorders
Gastrointestinal upset at 12 mo
|
22.5%
95/423 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
22.0%
95/431 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
25.1%
107/427 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
|
Blood and lymphatic system disorders
Any bleeding at 18 mo
|
10.2%
40/394 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
11.0%
45/410 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
9.5%
40/419 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
|
Psychiatric disorders
Increased appetite at 18 mo
|
19.3%
76/394 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
15.1%
62/410 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
14.4%
60/418 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
|
Psychiatric disorders
Decreased appetite at 18 mo
|
13.5%
53/394 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
11.0%
45/410 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
14.8%
62/419 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
|
Psychiatric disorders
Drowsiness at 18 mo
|
38.6%
152/394 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
43.2%
177/410 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
40.8%
171/419 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
|
Gastrointestinal disorders
Gastrointestinal upset at 18 mo
|
24.9%
98/394 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
24.1%
99/410 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
23.9%
100/418 • 18 months
Serious Adverse Events and mortality were assessed in all participants. Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.
|
Additional Information
Ian Kronish, MD, MPH, Principal Investigator
Center for Behavioral Cardiovascular Health
Phone: 212-342-1335
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place