Methods | Twelve-week double-blind, randomised, multicentre study. | |
Participants | Patients fulfilling DSM-III criteria for major depressive disorder, with a score of at least 20 on HDRS-21. Age range: not stated. Exclusion criteria: significant concurrent illness including renal, hepatic, cardiovascular or neurological disease, non-stabilised diabetes, other current Axis I psychiatric diagnosis; organic brain syndrome, past or present abuse of alcohol or drugs; pregnancy or lactating; ECT; continuous lithium therapy in preceeding 2 months, use of important psychotropic drug, current therapy with an anticoagulant or type 1 antiarrhytmic |
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Interventions | Fluoxetine: 101 participants. Paroxetine: 102 participants. Fluoxetine dose range: 20-80 mg/day. Paroxetine dose range: 20-50 mg/day. Chloral hydrate was allowed just during the first two weeks of the study |
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Outcomes | Primary outcome: Hamilton Rating Scale for Depression (HDRS-21), Clinical Global Impression. Secondary outcomes: HAM- anxiety and somatisation scores. |
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Notes | Response: decrease of at least 50% in the HAM-D total score and/or a total score less than 10. Two participants dropped out (1 in the fluoxetineand 1 in the paroxetine group) due to attempted suicide. Funding: by industry |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Allocation concealment? | Unclear | B - Unclear |