| Methods |
Twelve‐week randomised, double‐blind, multicentre study |
| Participants |
Outpatients fulfilling DSM‐III‐R criteria for moderate to moderately severe major depression without a history of mania or hypomania, with a score of at least 18 on the Hamilton Rating Scale for Depression‐21 item (HDRS‐21), of at least 8 on the Raskin Depression Scale (and grater than Covi Anxiety Scale (CAS) score).
Mean age: 41.3 years
Exclusion criteria: schizophrenia, adjustment disorder, bipolar disorder, panic disorder, social phobia, obsessive compulsive disorder, psychotic depression, atypical depression, serious concomitant medical illness, significant abnormal laboratory values, history of seizure disorder, high suicidal risk, recent history of alcohol or drug abuse, use other psychotropic drug within 14 days of baseline, ECT within 3 months of baseline, any investigational drug within 30 days of baseline, previous treatment with paroxetine, pregnancy, childbearing potential without contraceptive. |
| Interventions |
Fluoxetine: 54 participants
Paroxetine: 55 participants
Placebo: 19 participants
Fluoxetine dose range: 20‐80 mg/day
Paroxetine dose range: 20‐50 mg/day |
| Outcomes |
HDRS‐21, Covy Anxiety Scale (CAS), Raskin Depression Scale |
| Notes |
Response: decrease of at least 50% in the HDRS‐21 total score
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 |
Unclear risk |
Quote: "we chose to conduct all analyses with an ITT approach". Number and reasons for dropout reported |
| Selective reporting (reporting bias) |
Unclear risk |
Adverse events reported. Primary and secondary endpoint reported with standard deviations |
| Other bias |
High risk |
Quote: "this study was supported by SmithKline Beecham Pharmaceuticals" and this industry produces paroxetine |
