Hypericum extract LI160 for depression with atypical features

Preliminary data suggest, that Hypericum extract LI160 is effective in atypical depression. 200 patients fulfilling ICD–10 criteria of a major depression were randomized into a double blind trial of 600mg LI160 vs. placebo with a duration of 8 weeks. Half of the population had mild, the other half moderate severity. The presence of atypical vegetative features was required, as defined in two steps: 1. exclusion of patients with melancholic features; 2. inclusion of patients with at least one atypical symptom as defined as a score of 2 of the items 22–26 (hypersomnia and appetite-increase) on the Hamilton Depression Rating Scale (HDRS)–28. Episode-duration was at least 3 month. Outcome variables were the HDRS–17, the patient health questionnaire (PHQ)-depression subscale, the Clinical Global Impression (CGI) and the Hamilton Anxiety Scale (HAMA) and morning urine cortisol. LI160 showed a nearly significant superiority in comparison to placebo on HDRS–17 (p=0.05). On the HAMA, the PHQ and the CGI (improvement) LI160 showed a highly significant superiority over placebo (p<0.01 for all these measures). This was driven by a highly significant superiority of LI160 on all scales in the moderately depressed patients. In the total group reduced depression was correlated with increased urine cortisol. LI160 shows a robust and clinically important effect in patients with atypical depression. The sensitivity of the HDRS–17 in this population is questionable.