title: Hypericum extract LI 160 and fluoxetine in mild to moderate depression: a randomized, placebo-controlled multi-center study in outpatients.
abstract: Efficacy and tolerability of Hypericum LI 160 was compared to fluoxetine and placebo in mild to moderate Major Depression (DSM-IV) in a 4-week randomized, double-blind trial. One hundred and sixty-three outpatients from 15 general practitioner centers received either 900 mg Hypericum LI 160, 20 mg fluoxetine, or placebo daily. Amelioration was measured by the Hamilton and the Montgomery-Asberg Depression scales. Response and remission rates and global ratings by investigators and patients were measured. Adverse event reports, laboratory screening, vital signs, physical exams and ECG were collected. No significant differences could be observed regarding efficacy measures except for remission rate (Hypericum 24%; fluoxetine 28%; placebo 7 %). Hypericum was significantly better tolerated than fluoxetine. Hypericum LI 160 or fluoxetine were not more effective in short-term treatment in mild to moderate depression than placebo.
authors.affiliation: Department of Clinical Neuroscience, Psychiatry Section Karolinska Hospital, 17176, Stockholm, Sweden. lars.bjerkenstedt@nvso.sll.se
authors.forename: Lars
authors.initials: L
authors.lastname: Bjerkenstedt
authors.forename: Gunnar V
authors.initials: GV
authors.lastname: Edman
authors.forename: R Gisberth
authors.initials: RG
authors.lastname: Alken
authors.forename: Marcus
authors.initials: M
authors.lastname: Mannel
mesh_terms: D000328:Adult; D000704:Analysis of Variance; D018687:Antidepressive Agents, Second-Generation / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D003863:Depression / Q000145:classification / Q000188:drug therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D004341:Drug Evaluation; D004569:Electroencephalography / Q000379:methods; D005260:Female; D005473:Fluoxetine / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D020902:Hypericum; D008297:Male; D008875:Middle Aged; D010045:Outpatients; D010936:Plant Extracts / Q000627:therapeutic use*; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D018709:Statistics, Nonparametric; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018687:Antidepressive Agents, Second-Generation; C422326:Hypericum extract LI 160; D010936:Plant Extracts; D005473:Fluoxetine