Methods | Six-week randomised, double-blind two-centre study. | |
Participants | Outpatients fulfilling DSM-III-R criteria for major depressive episode, with a score of at least 18 on the HDRS-21. Age range: 18-75 years old. Exclusion criteria: pregnancy, lactation, severe coexisting disease, unstable diabetes, organic brain syndrome, history of alcohol or drug abuse, schizophrenia or psychosis, severe risk of suicide |
|
Interventions | Fluoxetine: 61 participants. Paroxetine: 60 participants. Fluoxetine dose: 20 mg/day. Paroxetine dose: 20 mg/day. |
|
Outcomes | Primary outcome: change from baseline on the HDRS total score at endpoint. Secondary outcomes: change from baseline in the Hamilton sub-factor scores (anxiety, retardation, sleep disturbance, melancholia, recognition), proportion of patients responding to treatment, change from baseline on the CGI-S and CGI-I |
|
Notes | Response: decrease of at least 50% in the HDRS total score. Funding: by industry |
|
Risk of bias | ||
Item | Authors’ judgement | Description |
Allocation concealment? | Unclear | B - Unclear |