| Methods |
Six‐week double‐blind, randomised study |
| Participants |
Patients fulfilling DSM‐III criteria for major depression, with a score of at least 18 on the Hamilton Rating Scale for Depression‐21 item (HDRS‐21).
Age range: 18‐65 years
Exclusion criteria: pregnancy, lactation, severe concomitant disease, schizophrenia, abuse of alcohol or drugs, severe risk of suicide, ECT in the previous 3 months, MAOI or oral neuroleptics in the previous 14 days, depot neuroleptics in the previous 4 weeks, patients receiving lithium. |
| Interventions |
Fluoxetine: 41 participants
Paroxetine: 37 participants
Fluoxetine dose range: 20‐60 mg/day
Paroxetine dose range: 20‐40 mg/day
Temazepam or other short‐acting benzodiazepines were permitted as hypnotic |
| Outcomes |
HDRS‐21, Montgomery and Asberg Scale for Depression (MADRS), Hopkins Symptoms Check List (HSLC), 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 |
Double blind, no further information |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Quote: "the Last Observation Carried Forward (LOCF) data set was used". Scores in follow‐up were reported without denominator. Reasons for withdrawal not clear |
| Selective reporting (reporting bias) |
High risk |
No follow‐up scores (MADRS, HDRS, HSLC) |
| Other bias |
High risk |
Funding by Smithkline, and this company produces paroxetine |
