| Methods |
Eight‐week double‐blind, multicentre study |
| Participants |
Outpatients suffering from a major depressive episode according to DSM‐III‐R, with a baseline score on Hamilton Rating Scale for Depression‐17 Item (HDRS‐17) of at least 18, recruited from nine separated psychiatric clinics.
Age: 18 years or more
Exclusion criteria: depression secondary to other conditions, concomitant illness of renal, cardiac or hepatic origin; hypersensitivity to other antidepressants, likelihood of poor compliance, risk of suicide, peptic ulcer history, an improvement of greater than 25% in the HDRS score during a pre‐treatment placebo washout period. |
| Interventions |
Fluoxetine: 56 participants
Sertraline: 52 participants
Fluoxetine dose range: 20‐60 mg/day
Sertraline dose range: 50‐150 mg/day
Benzodiazepines were allowed for hypnotic use and as maintenance treatment for pre‐existing anxiety |
| Outcomes |
HDRS‐17 and Hamilton Rating Scale for Anxiety (HAM‐A), Montgomery and Asberg Scale for Depression (MADRS), Zung Self‐Rating Scale for Anxiety, Leeds Sleep Evaluation Questionnaire, Clinical Global Impression Scale, including severity (CGI‐S) and improvement (CGI‐I) |
| Notes |
Seventy‐five per cent of the patients were women. Higher percentage of patients with a family history of psychiatric illness in the fluoxetine group. Higher percentage of patients with severe depression in the fluoxetine group (30.4%) than in the sertraline group (13.7%).
Funding: unclear |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
No information about randomisation procedure |
| Allocation concealment (selection bias) |
Unclear risk |
No information |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Quote: "double‐blind". No further information |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Quote: "double‐blind". No further information |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Insufficient information |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Incoherence between denominators |
| Selective reporting (reporting bias) |
High risk |
No follow‐up scores reported |
| Other bias |
Unclear risk |
Funding: unclear information |
