| Methods |
Eight‐week randomised, double‐blind, multicentre study |
| Participants |
Outpatients fulfilling DSM‐IV criteria for non‐psychotic major depressive disorder, with a score of at least 15 on the Hamilton Rating Scale for Depression‐17 item (HDRS‐17) and at least 4 on the Clinical Global Impression‐Severity of Illness (CGI).
Age range: 18‐65 years
Exclusion criteria: any primary DSM‐IV Axis I diagnosis other than major depressive disorder or any anxiety disorder as a primary diagnosis within the past year with the exception of specific phobias, history of substance abuse or dependence within the past year or a positive urine drug screen at study entry, failure of 2 or more adequate courses of antidepressant therapy during the present episode. |
| Interventions |
Fluoxetine: 33 participants
Duloxetine: 70 participants
Placebo: 70 participants
Fluoxetine dose: 20 mg/day
Duloxetine dose range: 40‐120 mg/day |
| Outcomes |
Primary outcome: HDRS‐17
Secondary outcomes: Montgomery and Asberg Scale for Depression (MADRS), CGI, Patient Global Impresion (PGI), Hamilton Rating Scale for Anxiety (HAM‐A) |
| 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 |
Quote: " this study used double‐blind placebo lead in such that investigators and patients did not know when randomisation occurred and when active study drug was first administered", no further information |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Quote: " this study used double‐blind placebo lead in such that investigators and patients did not know when randomisation occurred and when active study drug was first administered", no further information |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Quote: " this study used double‐blind placebo lead in such that investigators and patients did not know when randomisation occurred and when active study drug was first administered", further information |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Rating scale scores reported without denominators. Number and reasons for dropout not clearly reported |
| Selective reporting (reporting bias) |
High risk |
Mean scores reported without standard deviations. Only common treatment emergent adverse events reported |
| Other bias |
High risk |
First author's affiliation was Lilly Corporate Center and this company produces fluoxetine |
