OBJECTIVE: To determine the impact of self-reported heart disease (HD) on major depressive disorder (MDD) treatment outcomes. METHOD: This single-blind, 7-month prospective randomized trial enrolled 665 participants, 18-75 years old, from six primary and nine psychiatric care sites across the USA. Participants had at least moderately severe (baseline 17-item Hamilton Rating Scale of Depression ≥16), nonpsychotic chronic and/or recurrent MDD. Participants with and without self-reported HD were randomized into three treatment groups (1:1:1 ratio): escitalopram plus placebo, bupropion sustained-release plus escitalopram or venlafaxine extended-release plus mirtazapine. The primary outcome (remission) was defined by the last two consecutive 16-item Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR(16)) ratings: one had to be <8 and one <6. Secondary outcomes included response (reduction in QIDS-SR(16) >50%) side-effect burden, quality of life and functioning. A P value <.05 indicated statistical significance. RESULT: Participants with HD were less depressed at baseline and demonstrated fewer side effects at Treatment Weeks 12 and 28. The HD groups did not differ regarding remission [40.0% (16/40) vs. 38.2% (239/625), P=.5566] or response [50% (20/40) vs. 52.1% (314/625), P=.8055]. CONCLUSIONS: Despite apparent baseline and side-effect differences between participants with and without HD, the two groups did not differ regarding MDD treatment outcomes.
RCT Entities:
OBJECTIVE: To determine the impact of self-reported heart disease (HD) on major depressive disorder (MDD) treatment outcomes. METHOD: This single-blind, 7-month prospective randomized trial enrolled 665 participants, 18-75 years old, from six primary and nine psychiatric care sites across the USA. Participants had at least moderately severe (baseline 17-item Hamilton Rating Scale of Depression ≥16), nonpsychotic chronic and/or recurrent MDD. Participants with and without self-reported HD were randomized into three treatment groups (1:1:1 ratio): escitalopram plus placebo, bupropion sustained-release plus escitalopram or venlafaxine extended-release plus mirtazapine. The primary outcome (remission) was defined by the last two consecutive 16-item Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR(16)) ratings: one had to be <8 and one <6. Secondary outcomes included response (reduction in QIDS-SR(16) >50%) side-effect burden, quality of life and functioning. A P value <.05 indicated statistical significance. RESULT: Participants with HD were less depressed at baseline and demonstrated fewer side effects at Treatment Weeks 12 and 28. The HD groups did not differ regarding remission [40.0% (16/40) vs. 38.2% (239/625), P=.5566] or response [50% (20/40) vs. 52.1% (314/625), P=.8055]. CONCLUSIONS: Despite apparent baseline and side-effect differences between participants with and without HD, the two groups did not differ regarding MDD treatment outcomes.