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Effect of Hypericum perforatum (St John's wort) in major depressive disorder: a randomized controlled trial.

Publication ,  Journal Article
Hypericum Depression Trial Study Group, ; Davidson, JRT; Gadde, KM; Fairbank, JA; Krishnan, KRR; Califf, RM; Binanay, C; Parker, CB; Pugh, N ...
Published in: JAMA
April 10, 2002

CONTEXT: Extracts of Hypericum perforatum (St John's wort) are widely used for the treatment of depression of varying severity. Their efficacy in major depressive disorder, however, has not been conclusively demonstrated. OBJECTIVE: To test the efficacy and safety of a well-characterized H perforatum extract (LI-160) in major depressive disorder. DESIGN AND SETTING: Double-blind, randomized, placebo-controlled trial conducted in 12 academic and community psychiatric research clinics in the United States. PARTICIPANTS: Adult outpatients (n = 340) recruited between December 1998 and June 2000 with major depression and a baseline total score on the Hamilton Depression Scale (HAM-D) of at least 20. INTERVENTIONS: Patients were randomly assigned to receive H perforatum, placebo, or sertraline (as an active comparator) for 8 weeks. Based on clinical response, the daily dose of H perforatum could range from 900 to 1500 mg and that of sertraline from 50 to 100 mg. Responders at week 8 could continue blinded treatment for another 18 weeks. MAIN OUTCOME MEASURES: Change in the HAM-D total score from baseline to 8 weeks; rates of full response, determined by the HAM-D and Clinical Global Impressions (CGI) scores. RESULTS: On the 2 primary outcome measures, neither sertraline nor H perforatum was significantly different from placebo. The random regression parameter estimate for mean (SE) change in HAM-D total score from baseline to week 8 (with a greater decline indicating more improvement) was -9.20 (0.67) (95% confidence interval [CI], -10.51 to -7.89) for placebo vs -8.68 (0.68) (95% CI, -10.01 to -7.35) for H perforatum (P =.59) and -10.53 (0.72) (95% CI, -11.94 to -9.12) for sertraline (P =.18). Full response occurred in 31.9% of the placebo-treated patients vs 23.9% of the H perforatum-treated patients (P =.21) and 24.8% of sertraline-treated patients (P =.26). Sertraline was better than placebo on the CGI improvement scale (P =.02), which was a secondary measure in this study. Adverse-effect profiles for H perforatum and sertraline differed relative to placebo. CONCLUSION: This study fails to support the efficacy of H perforatum in moderately severe major depression. The result may be due to low assay sensitivity of the trial, but the complete absence of trends suggestive of efficacy for H perforatum is noteworthy.

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Published In

JAMA

DOI

ISSN

0098-7484

Publication Date

April 10, 2002

Volume

287

Issue

14

Start / End Page

1807 / 1814

Location

United States

Related Subject Headings

  • Statistics, Nonparametric
  • Sertraline
  • Regression Analysis
  • Psychiatric Status Rating Scales
  • Male
  • Hypericum
  • Humans
  • General & Internal Medicine
  • Female
  • Double-Blind Method
 

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Hypericum  Depression Trial Study Group, ., Davidson, J. R. T., Gadde, K. M., Fairbank, J. A., Krishnan, K. R. R., Califf, R. M., … Weisler, R. H. (2002). Effect of Hypericum perforatum (St John's wort) in major depressive disorder: a randomized controlled trial. JAMA, 287(14), 1807–1814. https://doi.org/10.1001/jama.287.14.1807
Hypericum  Depression Trial Study Group, Richard H., Jonathan R. T. Davidson, Kishore M. Gadde, John A. Fairbank, K Ranga Rama Krishnan, Robert M. Califf, Cynthia Binanay, et al. “Effect of Hypericum perforatum (St John's wort) in major depressive disorder: a randomized controlled trial.JAMA 287, no. 14 (April 10, 2002): 1807–14. https://doi.org/10.1001/jama.287.14.1807.
Hypericum  Depression Trial Study Group, Davidson JRT, Gadde KM, Fairbank JA, Krishnan KRR, Califf RM, et al. Effect of Hypericum perforatum (St John's wort) in major depressive disorder: a randomized controlled trial. JAMA. 2002 Apr 10;287(14):1807–14.
Hypericum  Depression Trial Study Group, Richard H., et al. “Effect of Hypericum perforatum (St John's wort) in major depressive disorder: a randomized controlled trial.JAMA, vol. 287, no. 14, Apr. 2002, pp. 1807–14. Pubmed, doi:10.1001/jama.287.14.1807.
Hypericum  Depression Trial Study Group, Davidson JRT, Gadde KM, Fairbank JA, Krishnan KRR, Califf RM, Binanay C, Parker CB, Pugh N, Hartwell TD, Vitiello B, Ritz L, Severe J, Cole JO, de Battista C, Doraiswamy PM, Feighner JP, Keck P, Kelsey J, Lin K-M, Londborg PD, Nemeroff CB, Schatzberg AF, Sheehan DV, Srivastava RK, Taylor L, Trivedi MH, Weisler RH. Effect of Hypericum perforatum (St John's wort) in major depressive disorder: a randomized controlled trial. JAMA. 2002 Apr 10;287(14):1807–1814.
Journal cover image

Published In

JAMA

DOI

ISSN

0098-7484

Publication Date

April 10, 2002

Volume

287

Issue

14

Start / End Page

1807 / 1814

Location

United States

Related Subject Headings

  • Statistics, Nonparametric
  • Sertraline
  • Regression Analysis
  • Psychiatric Status Rating Scales
  • Male
  • Hypericum
  • Humans
  • General & Internal Medicine
  • Female
  • Double-Blind Method