| A Double-blind, randomized trial of St John's wort, fluoxetine, and placebo in major depressive disorder. | |
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MedLine Citation:
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PMID: 16160619 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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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Authors:
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Maurizio Fava; Jonathan Alpert; Andrew A Nierenberg; David Mischoulon; Michael W Otto; John Zajecka; Harald Murck; Jerrold F Rosenbaum |
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Publication Detail:
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Type: Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Journal of clinical psychopharmacology Volume: 25 ISSN: 0271-0749 ISO Abbreviation: J Clin Psychopharmacol Publication Date: 2005 Oct |
Date Detail:
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Created Date: 2005-09-14 Completed Date: 2005-11-30 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 8109496 Medline TA: J Clin Psychopharmacol Country: United States |
Other Details:
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Languages: eng Pagination: 441-7 Citation Subset: IM |
Affiliation:
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Depression Clinical and Research Program, Massachusetts General Hospital, Boston, MA 02114, USA. mfava@partners.org |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Adult Aged Antidepressive Agents, Second-Generation / adverse effects, therapeutic use* Depressive Disorder, Major / drug therapy*, psychology Double-Blind Method Endpoint Determination Female Fluoxetine / adverse effects, therapeutic use* Humans Hypericum* Male Middle Aged Phytotherapy* / adverse effects Plant Extracts / therapeutic use Psychiatric Status Rating Scales |
| Chemical | |
Reg. No./Substance:
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0/Antidepressive Agents, Second-Generation; 0/Plant Extracts; 54910-89-3/Fluoxetine |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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