| Methods |
Sertraline vs Mianserin vs placebo
RCT
Country: Norway from 61 GPs |
| Participants |
N=372. 18‐79 years and symptoms of depression >2 weeks, severe enough to require treatment; Clinical Global impression score of at least 3, >=20 on MADRS score, <25% reduction in MADRS score over observation week. Exclusions: Dementia, schizophrenia, bipolar, organic mental disorder, not responding before to amitriptyline 150mg per day or equivalent, previous failure to respond to SSRI or mianserin, alcoholism, misuse of study drugs, Myocardial infarct in previous 3 months, epilepsy, hypotension, not willing to use safe contraception.
86 to 89% of participants had major depression according to DSM III‐R |
| Interventions |
All patients given emotional support and counselling from GPs.
Interventions: Sertraline 50 mg/day increased to 100 mg by 3rd week with tirations up to 150 mg after 4 weeks in non‐responders to a maximum of 200 mg at 6 weeks.
Mianserin started at 30mg increased to 60 mg at 1 week then increasing if not responding to 90 mg/day after 4 weeks to a maximum of 120 mg/day after 6 weeks if needed.
No information given about how the placebo was increased.
Given for 24 weeks |
| Outcomes |
36% drop outs over 24 weeks. At follow up: MADRS for Sertraline group mean=11.9 (SD 10.3) n=122, Mianserin group mean=11.3 (SD 9.1) n=121, and placebo group mean=14 (SD 10) n=129. The dose was titrated up to 120mg/day. Baseline SDs used as approximations because SDs for outcome values not published. Responders to treatment Sertraline (74/122), Mianserin = (65/121) and placebo = (60/129). |
| Notes |
Assumes that GPs gave the medication and did the assessments.
Average drug level of Sertraline was 114.6 mg/day and Mianserin 78 mg/day |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
