| Methods |
Six‐week randomised, double‐blind multicentre study |
| Participants |
Inpatients fulfilling DSM‐III‐R criteria for major depression, with a score of at least 24 on the Montgomery and Asberg Scale for Depression (MADRS).
Age range: 18‐65 years
Exclusion criteria: pregnancy or nursing, severe concomitant physical disease, severe risk of suicide, abuse of alcohol or illicit drugs, schizophrenia or psychosis, organic brain syndrome, history of serious allergic drug reaction, treatment with any investigational compound during the previous 6 months, lithium or ECT in the previous 3 months, depot neuroleptics in th previous month, MAOI or oral neuroleptics in the previous 2 weeks, present use of oral anticoagulant or psychotropic drug (except chloral hydrate: 500 mg for sleep). |
| Interventions |
Fluoxetine: 87 participants
Paroxetine: 89 participants
Fluoxetine dose: 20 mg/day
Paroxetine dose: 20 mg/day |
| Outcomes |
MADRS, Hamilton Rating Scale for Anxiety (HAM‐A), Hospital Anxiety and Depression (14 items), Clinical Global Impression (CGI) Severity |
| 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 |
Denominators of responders were different from number of randomised patients. Reasons and number of dropouts not clearly reported |
| Selective reporting (reporting bias) |
Unclear risk |
Only most common adverse events are reported. Endpoint scores reported without standard deviations |
| Other bias |
High risk |
Quote: "this research was supported by SmithKline Beecham Pharmaceuticals" and this company produces paroxetine |
