| Methods |
Concealment: consecutively numbered pharmacy
Blinding: Double‐blind
Drop‐outs/withdrawals: 7 of 51 in hypericum group, 9 of 51 in maprotiline group
Jadad score: 2‐2‐1
IV score: 1‐1‐1‐0.5‐0.5‐0.5 |
| Participants |
Number of patients included/analyzed: 102 /86
Demographics: 73 female, mean age 44 years in the Hypericum group and 48 years in the maprotiline group
Diagnosis: single, moderately severe depressive episode (ICD 10 F32.1) (according to information from the sponsor patients met DSM‐III‐R criteria for major depression); Setting: 6 practices in Germany (neurology/psychiatry)
Baseline: HAMD scores 20.5 +/‐ 3.7 in hypericum group and 21.5 +/‐ 3.9 in maprotiline group |
| Interventions |
Treatment: Hypericum extract LI 160 (Jarsin 300) 3x1 coated tablet (900 mg extract) daily for 4 weeks
Control: Maprotiline 3x1 coated tablet (75 mg) daily for 4 weeks |
| Outcomes |
Observation period 4 weeks
Physician‐rated: Hamilton Depression Scale (HAMD, 17 items; response = at least 50% reduction or score < 10), Clinical Global Impression Index (CGI), global assessment
Patient rated: Depression Scale von Zerssen D‐S, global assessment |
| Notes |
Additional information provided from sponsor (Lichtwer, Berlin, Germany) |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
