TY - JOUR
T1 - A double-blind, randomized trial of St John's wort, fluoxetine, and placebo in major depressive disorder
AU - Fava, Maurizio
AU - Alpert, Jonathan
AU - Nierenberg, Andrew A.
AU - Mischoulon, David
AU - Otto, Michael W.
AU - Zajecka, John
AU - Murck, Harald
AU - Rosenbaum, Jerrold F.
PY - 2005/10
Y1 - 2005/10
N2 - Objective: This study looks to compare the antidepressant efficacy and safety of a standardized extract of St John's wort with both placebo and fluoxetine. Method: After a 1-week single-blind washout, patients with major depressive disorder diagnosed by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition were randomized to 12 weeks of double-blind treatment with LI-160 St John's wort extract (900 mg/d), fluoxetine (20 mg/d), or placebo. The 17-item Hamilton Rating Scale for Depression (HAMD-17) was the primary efficacy measure, and analysis of covariance was used to compare differences in end point HAMD-17 scores across the 3 treatment groups, treating the baseline HAMD-17 as the covariate. Results: One hundred thirty-five patients (57% women; mean age, 37.3 ± 11.0; mean HAMD-17, 19.7 ± 3.2) were randomized to double-blind treatment and were included in the intent-to-treat analyses. Analysis of covariance analyses showed lower mean HAMD-17 scores at end point in the St John's wort group (n = 45; mean ± SD, 10.2 ± 6.6) compared with the fluoxetine group (n = 47; 13.3 ± 7.3; P < 0.03) and a trend toward a similar finding relative to the placebo group (n = 43; 12.6 ± 6.4; P = 0.096). There was also a trend toward higher rates of remission (HAMD-17 <8) in the St John's wort group (38%) compared with the fluoxetine group (30%) and the placebo group (21%). Overall, St John's wort appeared to be safe and well tolerated. Conclusion: St John's wort was significantly more effective than fluoxetine and showed a trend toward superiority over placebo. A (25%) smaller than planned sample size is likely to account for the lack of statistical significance for the advantage (indicating a moderate effect size, d = 0.45) of St John's wort over placebo.
AB - Objective: This study looks to compare the antidepressant efficacy and safety of a standardized extract of St John's wort with both placebo and fluoxetine. Method: After a 1-week single-blind washout, patients with major depressive disorder diagnosed by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition were randomized to 12 weeks of double-blind treatment with LI-160 St John's wort extract (900 mg/d), fluoxetine (20 mg/d), or placebo. The 17-item Hamilton Rating Scale for Depression (HAMD-17) was the primary efficacy measure, and analysis of covariance was used to compare differences in end point HAMD-17 scores across the 3 treatment groups, treating the baseline HAMD-17 as the covariate. Results: One hundred thirty-five patients (57% women; mean age, 37.3 ± 11.0; mean HAMD-17, 19.7 ± 3.2) were randomized to double-blind treatment and were included in the intent-to-treat analyses. Analysis of covariance analyses showed lower mean HAMD-17 scores at end point in the St John's wort group (n = 45; mean ± SD, 10.2 ± 6.6) compared with the fluoxetine group (n = 47; 13.3 ± 7.3; P < 0.03) and a trend toward a similar finding relative to the placebo group (n = 43; 12.6 ± 6.4; P = 0.096). There was also a trend toward higher rates of remission (HAMD-17 <8) in the St John's wort group (38%) compared with the fluoxetine group (30%) and the placebo group (21%). Overall, St John's wort appeared to be safe and well tolerated. Conclusion: St John's wort was significantly more effective than fluoxetine and showed a trend toward superiority over placebo. A (25%) smaller than planned sample size is likely to account for the lack of statistical significance for the advantage (indicating a moderate effect size, d = 0.45) of St John's wort over placebo.
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U2 - 10.1097/01.jcp.0000178416.60426.29
DO - 10.1097/01.jcp.0000178416.60426.29
M3 - Article
C2 - 16160619
AN - SCOPUS:25444520063
SN - 0271-0749
VL - 25
SP - 441
EP - 447
JO - Journal of Clinical Psychopharmacology
JF - Journal of Clinical Psychopharmacology
IS - 5
ER -