THE RELATIONSHIP BETWEEN EARLY CHANGES IN THE HAMD-17 ANXIETY/SOMATIZATION FACTOR ITEMS AND TREATMENT OUTCOME AMONG DEPRESSED OUTPATIENTS

Objective/Background: The HAM-D-17 Anxiety/Somatization factor includes six items: Anxiety (psychic), Anxiety (somatic), Somatic Symptoms (G.I.), Somatic Symptoms (general), Hypochondriasis, and Insight. This study examines the relationship between early changes (defined as baseline to week 1) in these HAM-D-17 Anxiety/Somatization Factor items and treatment outcome among major depressive disorder (MDD) patients participating in a study comparing the antidepressant efficacy of a standardized extract of hypericum with both placebo and fluoxetine. Methods: Following a 1-week, single-blind wash-out, patients with MDD diagnosed by the Structured Clinical Interview for DSM-IV (SCID) were randomized to 12 weeks of double-blind treatment with hypericum extract (900 mg/day), fluoxetine (20 mg/day), or placebo. The 17-item Hamilton Rating Scale for Depression (HAM-D-17) was the primary efficacy measure. The ability of early changes in HAM-D-17 anxiety/somatization factor items to predict treatment outcome were assessed separately for patients who received active treatment (hypericum or fluoxetine) versus placebo with a logistic regression method. Results: 135 patients (57% women, mean age = 37.3 + 11.0; mean baseline HAM-D-17 = 19.7 +3.2) were randomized to double-blind treatment and were included in the intent-to-treat analyses. The remission rates were 38% in the hypericum group, 30% in the fluoxetine group, and 21% in the placebo group. After adjusting for baseline HAM-D-17 scores and for multiple comparisons with the Bonferroni correction, patients who remitted (HAM-D-17 <8) after active treatment had significantly greater improvement in Somatic Symptoms (General) scores than non-remitters. No other significant differences in early changes were noted for the remaining items between remitters versus non-remitters who received active treatment. For patients treated with placebo, early change was not predictive of remission for any of the items. Conclusion: The presence of early improvement on the HAM-D-17 item concerning fatigue and general somatic symptoms was significantly predictive of achieving remission at endpoint with active treatment but not with placebo.