Relationship Between Depression Severity Entry Criteria and Antidepressant Clinical Trial Outcomes

Antidepressant–placebo differences in 16 clinical trials over 10 years at a single site: role of baseline severity

“…However, "forcing" high depression entry scores may have a paradoxical and undesirable effect (Khan et al 2007a). In other words, if the trial requirements for entry are very high, such as the baseline mean total HAM-D17 of 24 or higher, the outcome is worse than among trials requiring much lower baseline scores, such as a mean total HAM-D score of 14 or higher.…”

Double-Blind Randomized Treatment of Poststroke Depression Using Nefiracetam

“…We have found that placebo response rates are significantly higher among poststroke patients who are older and with less severe cognitive impairment (2007 unpublished data), and others have reported greater separation of active and placebo response among more severely depressed patients. Khan et al, 40 however, reported that higher placebo response rates were found in trials requiring higher pre-randomization depressive symptoms. If less severe depression led to higher placebo response, however, this may explain our finding of a significant treat-ROBINSON et al ment effect among those in the top quintile of depression severity.…”

Relationship between Baseline Severity of Depression and Antidepressant Treatment Outcome

“…Nevertheless, it should be considered when absolute responder rates for a compound are reported alone without comparison to a control group. Moreover, this aspect could be part of the discussion of the results of meta-analyses and randomised controlled trials indicating a larger eff ect of antidepressants in patients with higher baseline depression severity [7,14,15,21,29,31] . Since many of the HAMD-17 items refl ect the neurovegetative symptoms of melancholic depression (related to sleep or appetite) which are not part of the specifi c antidepressant eff ect, we also focused on the core items in HAMD-17 using the HAMD-6 [2] .…”