Trial Outcomes & Findings for Antidepressant Medication Treatment for Depression in Individuals With Chronic Heart Failure (NCT NCT00078286)

NCT ID: NCT00078286

Last Updated: 2013-02-27

Results Overview

Symptoms of depression (as measured by the Hamilton Depression Rating Scale, HDRS) in congestive heart failure patients with clinical depression after treatment with sertraline or placebo. The 17-item Hamilton Depression Rating Scale (HDRS) is a rater-administered assessment of depression severity, with total score ranges from 0 (not at all depressed) to 52 (most severely depressed). Change in depression was measured as the difference between the 12-week HDRS scores and the baseline HDRS scores. Thus, a negative value reflects an improvement in depressive symptoms over the 12-week period.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 469 participants
• Primary outcome timeframe: Measured at Week 12
• Results posted on: 2013-02-27

Participant Flow

Recruitment began in November, 2003 and concluded in March, 2008. Subjects were recruited from cardiology inpatient units as well as outpatient cardiology clinics.

Participant milestones

Measure	Sertraline Participants will take sertraline for 12 weeks	Placebo Participants will take placebo for 12 weeks
Overall Study STARTED	234	235
Overall Study COMPLETED	138	152
Overall Study NOT COMPLETED	96	83

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Antidepressant Medication Treatment for Depression in Individuals With Chronic Heart Failure

Baseline characteristics by cohort

Measure	Sertraline n=234 Participants Participants will take sertraline for 12 weeks	Placebo n=235 Participants Participants will take placebo for 12 weeks	Total n=469 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0.0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	131 Participants n=5 Participants	147 Participants n=7 Participants	278.0 Participants n=5 Participants
Age, Categorical >=65 years	103 Participants n=5 Participants	88 Participants n=7 Participants	191.0 Participants n=5 Participants
Age Continuous	62.9 years STANDARD_DEVIATION 10.5 • n=5 Participants	61.4 years STANDARD_DEVIATION 11.1 • n=7 Participants	62.1 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	101 Participants n=5 Participants	89 Participants n=7 Participants	190.0 Participants n=5 Participants
Sex: Female, Male Male	133 Participants n=5 Participants	146 Participants n=7 Participants	279.0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at Week 12

Population: Analysis was based on intent to treat (ITT), using random coefficient modeling.

Symptoms of depression (as measured by the Hamilton Depression Rating Scale, HDRS) in congestive heart failure patients with clinical depression after treatment with sertraline or placebo.

The 17-item Hamilton Depression Rating Scale (HDRS) is a rater-administered assessment of depression severity, with total score ranges from 0 (not at all depressed) to 52 (most severely depressed). Change in depression was measured as the difference between the 12-week HDRS scores and the baseline HDRS scores. Thus, a negative value reflects an improvement in depressive symptoms over the 12-week period.

Outcome measures

Measure	Sertraline n=234 Participants Participants will take sertraline for 12 weeks	Placebo n=235 Participants Participants will take placebo for 12 weeks
Symptoms of Depression in Congestive Heart Failure Patients With Clinical Depression After Treatment With Sertraline or Placebo	-7.1 HDRS Change Score Standard Deviation 0.5	-6.8 HDRS Change Score Standard Deviation 0.5

SECONDARY outcome

Timeframe: Measured at Week 12

Population: Analysis was based on intent to treat (ITT).

Composite cardiovascular scores are calculated for each participant using recorded cardiac events, morbidity/mortality, rehospitalization, and discontinuation due to cardiovascular events. Composite score is compared for sertraline and placebo treatment groups.

Outcome measures

Measure	Sertraline n=138 Participants Participants will take sertraline for 12 weeks	Placebo n=152 Participants Participants will take placebo for 12 weeks
Percentage of Cardiac Events and Morbidity / Mortality, Including Rehospitalization, in Congestive Heart Failure Patients With Depression After Treatment With Sertraline or Placebo. Cardiovascular Status Worsened	29.9 percentage of participants	31.1 percentage of participants
Percentage of Cardiac Events and Morbidity / Mortality, Including Rehospitalization, in Congestive Heart Failure Patients With Depression After Treatment With Sertraline or Placebo. Cardiovascular Status Improved	40.6 percentage of participants	43.8 percentage of participants
Percentage of Cardiac Events and Morbidity / Mortality, Including Rehospitalization, in Congestive Heart Failure Patients With Depression After Treatment With Sertraline or Placebo. Cardiovascular Status Unchanged	29.5 percentage of participants	25.1 percentage of participants

Adverse Events

Sertraline

Serious events: 57 serious events

Other events: 22 other events

Deaths: 0 deaths

Placebo

Serious events: 63 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sertraline n=234 participants at risk Serious adverse events in Sertraline Arm	Placebo n=235 participants at risk Serious adverse events in Placebo Arm
Cardiac disorders Cardiovascular	17.1% 40/234 • Number of events 69 • 12-weeks All participants were followed via phone or mail to ascertain clinical events and vital status every 2 weeks during the 12-week treatment phase. The national death index was used to ascertain vital status of participants who could not be reached via phone or mail.	18.7% 44/235 • Number of events 72 • 12-weeks All participants were followed via phone or mail to ascertain clinical events and vital status every 2 weeks during the 12-week treatment phase. The national death index was used to ascertain vital status of participants who could not be reached via phone or mail.
Psychiatric disorders Psychiatric	0.00% 0/234 • 12-weeks All participants were followed via phone or mail to ascertain clinical events and vital status every 2 weeks during the 12-week treatment phase. The national death index was used to ascertain vital status of participants who could not be reached via phone or mail.	0.85% 2/235 • Number of events 2 • 12-weeks All participants were followed via phone or mail to ascertain clinical events and vital status every 2 weeks during the 12-week treatment phase. The national death index was used to ascertain vital status of participants who could not be reached via phone or mail.
General disorders Noncardiovascular and nonpsychiatric	7.3% 17/234 • Number of events 29 • 12-weeks All participants were followed via phone or mail to ascertain clinical events and vital status every 2 weeks during the 12-week treatment phase. The national death index was used to ascertain vital status of participants who could not be reached via phone or mail.	7.2% 17/235 • Number of events 22 • 12-weeks All participants were followed via phone or mail to ascertain clinical events and vital status every 2 weeks during the 12-week treatment phase. The national death index was used to ascertain vital status of participants who could not be reached via phone or mail.

Other adverse events

Measure	Sertraline n=234 participants at risk Serious adverse events in Sertraline Arm	Placebo n=235 participants at risk Serious adverse events in Placebo Arm
Cardiac disorders Congestive Heart Failure	4.7% 11/234 • Number of events 19 • 12-weeks All participants were followed via phone or mail to ascertain clinical events and vital status every 2 weeks during the 12-week treatment phase. The national death index was used to ascertain vital status of participants who could not be reached via phone or mail.	4.3% 10/235 • Number of events 20 • 12-weeks All participants were followed via phone or mail to ascertain clinical events and vital status every 2 weeks during the 12-week treatment phase. The national death index was used to ascertain vital status of participants who could not be reached via phone or mail.
Cardiac disorders Unstable Angina	0.85% 2/234 • Number of events 5 • 12-weeks All participants were followed via phone or mail to ascertain clinical events and vital status every 2 weeks during the 12-week treatment phase. The national death index was used to ascertain vital status of participants who could not be reached via phone or mail.	0.85% 2/235 • Number of events 5 • 12-weeks All participants were followed via phone or mail to ascertain clinical events and vital status every 2 weeks during the 12-week treatment phase. The national death index was used to ascertain vital status of participants who could not be reached via phone or mail.
Cardiac disorders Other Cardiovascular	3.8% 9/234 • Number of events 12 • 12-weeks All participants were followed via phone or mail to ascertain clinical events and vital status every 2 weeks during the 12-week treatment phase. The national death index was used to ascertain vital status of participants who could not be reached via phone or mail.	4.7% 11/235 • Number of events 16 • 12-weeks All participants were followed via phone or mail to ascertain clinical events and vital status every 2 weeks during the 12-week treatment phase. The national death index was used to ascertain vital status of participants who could not be reached via phone or mail.

Additional Information

Dr. Ranga Krishnan

Duke University

Phone: 919-668-3647

Email: krish001@mc.duke.edu

Results disclosure agreements

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