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 HDRS-17, of at least 8 on the Raskin Depression Scale (and grater than Covi score). Mean age: 41.3 years. Exclusion criteria: schizophrenia, adjustment disorder, bipolar disorder, panic disorder, social phobia, obsessive complusive 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 |
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Interventions | Fluoxetine: 54 participants. Paroxetine: 55 participants. Placebo: 19 participants. Fluoxetine dose range: 20-80 mg/day. Paroxetine dose range: 20-50 mg/day. |
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Outcomes | Hamilton Rating Scale for Depression (HDRS-21), Covi Anxiety Scale, Raskin Depression Scale | |
Notes | Response: decrease of at least 50% in the HDRS-21 total. score. Funding: by industry |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Allocation concealment? | Unclear | B - Unclear |