| Methods |
Twelve‐week double‐blind randomised multicentre study |
| Participants |
Outpatients meeting DSM‐IV diagnostic criteria for major depression, with a minimum baseline score of 20 on the Hamilton Rating Scale for Depression‐21 item (HDRS‐21), recruited from three clinical sites.
Age range: 18‐65 years
Exclusion criteria: known sensitivity to venlafaxine or fluoxetine, a history of any clinically significant cardiac, hepatic or renal disease or abnormalities on a screening physical examination, ECG or laboratory tests, with any mental or neurologic disorder and breast‐feeding women; used of any investigational drug, antipsychotic drug, electroconvulsive therapy or sumatriptan within 30 days of baseline, fluoxetine within 21 days and MAOIs within 14 days. |
| Interventions |
Fluoxetine: 47 participants
Venlafaxine: 40 participants
Fluoxetine dose range: 20‐40 mg/day
Venlafaxine dose range: 75‐150 mg/day |
| Outcomes |
HDRS‐21, Montgomery and Asberg Scale for Depression (MADRS), Clinical Global Impression (CGI) |
| Notes |
Patients in the fluoxetine group had more chronic histories of depression at baseline. Predominance of females in the whole study.
Funding: by industry |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "Patients were allocated to treatments groups using a balanced randomisation from randomly permuted blocks" |
| 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: "the investigators were provided individual sealed envelopes" |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Quote: "Efficacy analysis were performed on ITT basis using a last observation carried forward method (LOCF)", but scores reported without denominator. Reasons and number of dropouts reported |
| Selective reporting (reporting bias) |
Unclear risk |
Only most common side effects reported (at last 7% incidence). Mean endpoint scores and standard deviation reported |
| Other bias |
High risk |
First author's affiliation was Wyeth‐Lederle, Portugal, and this company produces venlafaxine |
