The relationship between early changes in the HAMD-17 anxiety/somatization factor items and treatment outcome among depressed outpatients.

Abstract

The 17-item Hamilton Rating Scale for Depression (HAMD-17) Anxiety/Somatization factor includes six items: Anxiety (psychic), Anxiety (somatic), Somatic Symptoms (gastrointestinal), Somatic Symptoms (general), Hypochondriasis and Insight. This study examines the relationship between early changes (defined as those observed between baseline and week 1) in these HAMD-17 Anxiety/Somatization Factor items and treatment outcome among major depressive disorder (MDD) patients who participated in a study comparing the antidepressant efficacy of a standardized extract of hypericum with both placebo and fluoxetine. Following a 1-week, single-blind washout, 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 relationship between early changes in HAMD-17 anxiety/somatization factor items and treatment outcome was assessed separately for patients who received study treatment (hypericum or fluoxetine) versus placebo with a logistic regression method. One hundred and thirty-five patients (female 57%, mean age=37.3+/-11.0 years; mean baseline HAMD-17=19.7+/-3.2 years) were randomized to double-blind treatment and were included in the intent-to-treat (ITT) analyses. After adjusting for baseline HAMD-17 scores and for multiple comparisons with the Bonferroni correction, patients who remitted (HAMD-17 score <8) after study treatment had significantly greater early 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 after Bonferroni correction. In conclusion, the presence of early improvement on the HAMD-17 item concerning fatigue and general somatic symptoms is significantly predictive of achieving remission at endpoint with active study treatment but not with placebo.

• Authors: Amy Farabaugh, David Mischoulon, Maurizio Fava, Shirley L Wu, Alessandra Mascarini, Eliana Tossani, Jonathan E Alpert
• Journal: International clinical psychopharmacology (Int Clin Psychopharmacol) Vol. 20 Issue 2 Pg. 87-91 (Mar 2005) ISSN: 0268-1315 [Print] England
• PMID: 15729083 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Antidepressive Agents
• Antidepressive Agents, Second-Generation
• Plant Extracts
• Fluoxetine

Topics

• Adolescent
• Adult
• Aged
• Antidepressive Agents (therapeutic use)
• Antidepressive Agents, Second-Generation (therapeutic use)
• Anxiety (complications, psychology)
• Depressive Disorder, Major (drug therapy, psychology)
• Double-Blind Method
• Female
• Fluoxetine (therapeutic use)
• Humans
• Hypericum
• Male
• Middle Aged
• Plant Extracts (therapeutic use)
• Psychiatric Status Rating Scales
• Somatoform Disorders (complications, psychology)
• Treatment Outcome