| Methods |
Twenty four‐week, double‐blind, randomised multicentre study. |
| Participants |
General Practice patients fulfilling DSM‐III‐R criteria for major depression with a minimum baseline score of 21 on Montgomery‐Asberg Depression Rating Scale (MADRS).
Age range: 18‐70 years old.
Exclusion criteria: pregnancy, lactating, inadequate method of contraception, severe depression of psychotic dimension, history of serious suicide attempt or suicide risk, therapy refractory depression, previous treatment with sertraline or citalopram without significant effect, bipolar disorder, previous or present history of alcohol or drug abuse, history of epilepsy, known intolerance or allergic reactions to SSRIs, therapy with lithium within the preceding month, currently receiving and unable to discontinue any other psychotropic medication, except for a hypnotic for insomnia or a daytime anxiolytic, currently receiving treatment with cimetidine, warfarin or tryptophan, significant hepatic or renal disease, previous participation in the study. Patients who had been receiving antidepressants drugs required to have a washout period of at least 3 weeks. |
| Interventions |
Sertraline: 200 participants.
Citalopram: 200 participants.
Sertraline dose: 50‐150 mg/day.
Citalopram dose: 20‐60 mg/day.
Permitted Nitrazepam 2.5‐10 mg/day, flunitrazepam 0.5‐2 mg/day and oxazepam 15‐25 mg/day. |
| Outcomes |
Primary Outcome: change in MADRS, Clinical Global Impression‐Severity (CGI‐S) and Clinical Global Impression‐Improvement (CGI‐I). |
| Notes |
This study was funded by Pfizer (sertraline manufacturer). |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "randomized". Probably done, as a similar trial by these investigators included the same phrase and used a proper method of allocation. |
| Allocation concealment (selection bias) |
Unclear risk |
Insufficient information. |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Quote: "double‐dummy" but we have no other information. |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Missing standard deviations on MADRS data. |
| Selective reporting (reporting bias) |
Unclear risk |
The study protocol is not available. |
| Other bias |
Unclear risk |
Insufficient information to assess whether an important risk of bias exists. |
