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We investigated 243 patients from a series of comparator and/or placebo-controlled, double-blind trials of several mechanistically distinct antidepressants. Data were analyzed for changes in suicidal ideation during trial participation. Ambulatory referrals with a current DSM-III-R major depression, corroborated by a structured interview, were screened; those fulfilling entrance criteria began a 1-week, single-blind placebo run-in. Pool 1 (placebo comparator) subjects who continued to meet entrance criteria at their baseline visit were blindly randomized to receive either placebo (n = 49) or one of several novel antidepressant drugs (n = 81). Pool 2 subjects (active comparator) were randomized to either a novel antidepressant (n = 66) or a tricyclic antidepressant comparator (n = 57). Trial duration ranged from 5 to 8 weeks. Patient compliance was monitored by a regular pill count from each subject's blister pack. Analyses were conducted on Pool 1 and Pool 2 separately. Ego-dystonic suicidal preoccupation or acts were not reported in either group. There was a statistically significant treatment difference in Hamilton Depression Rating Scale item 3 mean peak change (Pool 1); patients treated with a novel antidepressant demonstrated a mean decrease in HDRS item 3 (improvement), those patients randomized to placebo experienced a mean score increase (worsening). No statistically significant treatment difference in mean peak change difference factors (CDFs) between the novel antidepressants and conventional tricyclic antidepressant comparators (Pool 2) was observed. A statistically significant correlation between item 3 change and total HDRS-17 change also emerged (both treatments within each pool). Increased suicidal ideas/behaviors may emerge during depression “treatment.” However, in this study it occurred more frequently among placebo recipients, suggesting a change in suicidal ideation was a reflection of the underlying disease process. Not surprisingly, antidepressants improved suicidal ideation to a greater extent than placebo. Depression 2:73–79 (1994). © 1994 Wiley-Liss, Inc. |
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