| Methods |
Six‐week randomised, double‐blind study |
| Participants |
Patients fulfilling DSM‐III‐R criteria for major depression, with a score of at least 22 on the Montgomery and Asberg Scale for Depression (MADRS).
Age range: 18‐70 years
Exclusion criteria: concurrent treatment for depressive illness, use of other drugs with psychopharmacological effect, serious risk of suicide, significant cardiac, renal or hepatic disease, pregnancy, lactation, absence of contraception. |
| Interventions |
Fluoxetine: 51 participants
Dothiepin: 56 participants
Fluoxetine dose: 20 mg/day
Dothiepine dose range: 75‐150 mg/day |
| Outcomes |
Hamilton Rating Scale for Depression (HDRS), MADRS, Brief Psychiatric Rating Scale (BPRS), Clinical Global Impression (CGI) |
| Notes |
Funding: by industry |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Randomised, no further information |
| Allocation concealment (selection bias) |
Unclear risk |
No information provided |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Double blind, no further information |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Double blind, no further information |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Quote: "double dummy", no further information |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Reasons and number of dropouts not clearly reported. Statistical analysis was not on an ITT basis |
| Selective reporting (reporting bias) |
Unclear risk |
End‐point mean scores and standard deviations reported. Side effects not clearly reported |
| Other bias |
High risk |
First author's affiliation was Eli Lilly, and this company produces fluoxetine |
