| Methods |
Concealment: numbered pharmacy
Blinding: double‐blind
Drop‐outs/withdrawals: 18 of 186 (hypericum), 25 of 189 placebo)
Jadad score: 1‐2‐0
IV score: 1‐0‐1‐1‐1‐0.5 |
| Participants |
Patients included/analyzed: 375/375
Demographics: 297 female, mean age 41 years
Diagnosis: mild to moderate depression (DSM‐IV 296.21/22/31/32)
Setting: 26 psychiatric centers and practices in France
Baseline: HAMD score hypericum group 21.9 +/‐ 1.7, placebo group 21.9 +/‐ 1.7 |
| Interventions |
Treatment: Hypericum extract WS 5570 3x1 tablet (900 mg) for 6 weeks
Control: placebo for 6 weeks |
| Outcomes |
Observation period: 3‐7 days run‐in, 6 weeks treatment
Physician‐rated: Hamilton Depression Scale (HAMD, 17 items; response = at least 50% reduction), Montgomery‐Asberg Depression Rating Scale (MADRS), Clinical Global Impression Index (CGI)
Patient‐rated: Symptom Check List (SCL‐58) |
| Notes |
Trial with preplanned interim analysis with 169 patients (no significant difference)
Additional information provided by sponsor (Schwabe, Karlsruhe) |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
