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Design
8 week randomised {allocation concealed*}
, blinded (clinicians and patients),* placebo controlled trial.
Setting
18 general practitioners' practices in Germany.
Patients
263 patients who were 1865 years of age (mean age 47 y, 75% women) and had a diagnosis of moderate depression; score of
18 on the Hamilton Depression Rating Scale (HDRS); clinical global impression rating of moderate, marked, or severe; and depression lasting
4 weeks and
2 years. Exclusion criteria included bipolar disorders, alcohol or drug dependence, or suicidal risk. 230 patients (87%) completed the study; 251 (95%) were included in an intention to treat analysis.
Intervention
Patients were allocated to Hypericum extract (STEI 300, Steiner Arzneimittel, Berlin, Germany), 1050 mg/day (n=106); imipramine, 50 mg/day titrated to 100 mg/day by day 5 (n=110); or placebo (n=47).
Main outcome measures
The primary end point was change from baseline in HDRS score. Hypericum was compared with placebo at 6 weeks and with imipramine at 8 weeks.
Main results
Etienne Vermeire, MD
University of Antwerp Antwerp, Belgium
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