| Methods |
Imipramine vs placebo vs hypericum extract
RCT. Participants selected from 18 general practitioners in Germany |
| Participants |
N=263 (251 in ITT analysis). Age 18‐65 years (mean=47 years)
Imipramine n=105, placebo n=46, hypericum extract n=100.
ICD‐10 moderate depressive episode, HAMD >=18, a clinical global impression rating of severity (item 1) of moderately, markedly or severely ill, depression duration of 4 weeks to 2 years. Exclusion: mild or severe depressive disorder, bi‐polar, alcohol or drug dependence, suicidal risk, long term use of lithium or carbamazepine, other psychotropic drugs, > 3 months of benzodiazepines general or specific contraindications to imipramine. |
| Interventions |
Patients screened for 1 week before treatment.
All patients treated with 3 capsules of trial drug daily.
Imipramine started at 50 mg on the first treatment day.75 mg days 2‐4,then 100 mg. Identical placebo for placebo and Hypericum. Duration 8 weeks |
| Outcomes |
4.5% (12) drop outs.
At 8 weeks: HAMD mean = 8 (SD 4.2) n=109 in Imipramine group, and mean = 10.6 (SD 4.0) n=46 in placebo group.
At 1 week: HAMD n=105 mean = 20.7 (SD 4.2) in Imipramine group vs n=46 mean = 19.2 (SD 4.0) in placebo group.
At 2 weeks n=105 mean = 16.7 (SD 4.2) vs n=47 mean = 18 (SD 4.0).
At 4 weeks: n=105 mean = 12.7 (SD 4.2) vs n=47 mean = 14.2 (SD 4.0).
Clinical Global Impression scale
proportion (much or very much) responding to Imipramine 70/105 and 29/46 in placebo group.
Side effects not necessarily leading to withdrawal: Imipramine 51/110 and 9/47 in placebo.
Any adverse events: 19% in placebo and 46% in imipramine group. Dry mouth: 13% in placebo and 38% in Imipramine group. Nausea: 2% in placebo and 11% in Imipramine group, Constipation: 6% and 6%, respectively.
Headache: 2% and 6%.
Palpitations: 0% and 6%.
Dizziness 2% and 6%.
Adverse effects leading to withdrawal: 0/47 from placebo group and 1/110 from imipramine group. |
| Notes |
Not clear who treated patients. Authors are either psychiatrists or psychologists.
Analysis was by Intention to treat |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
