Methods | Eight-week randomised, double-blind multicentre study. | |
Participants | In- and outpatients fulfilling DSM-III-R criteria for moderate to severe major depression, with a score of at least 18 on the first 17 items of HDRS and a score of at least 3 on the CGI. Age range: 18-80 years old. Exclusion criteria: MADRS score more than 40, suicidal ideation, history of mania, hypomania or psychosis, comorbid severe psychiatric disorder, organic mood disorder, psychotropic drug dependence, pregnancy, lactation, clinically significant renal, hepatic, cardiovascular, respiratory, cerebrovascular disease, use of concomitant serotonergic drug (including lithium and carbamazepine) |
|
Interventions | Fluoxetine: 82 participants. Sertraline: 83 participants. Fluoxetine dose range: 20-40 mg/day. Sertraline dose range: 50-100 mg/day. Chloral hydrate and short acting benzodiazepines as hypnotics Outcomes Hamilton Rating Scale for Depression, Montgomery and Asberg Scale for Depression, CGI-I, CGI-S |
|
Notes | Response: decrease of at least 50% in the total score on the HDRS or MADRS, or a score less than 10 on the HDRS. Funding: by industry | |
Risk of bias | ||
Item | Authors’ judgement | Description |
Allocation concealment? | Unclear | B - Unclear |