Bressa 1989.
Methods | Five‐week, double‐blind, randomised study | |
Participants | Outpatients fulfilling DSM‐III criteria for major depression, with a score of at least 20 on Hamilton Rating Scale for Depression (HDRS). Age: not stated Exclusion criteria: suicidal ideas, psychosis, seizure disorders, serious cardiac, renal or hepatic disease, alcoholism or drug abuse, use of antidepressant drug with the preceding 14 days, concurrent medication potentially interacting. |
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Interventions | Fluoxetine: 18 participants Imipramine: 12 participants Fluoxetine dose range: 20‐60 mg/day imipramine dose range: 75‐175 mg/day |
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Outcomes | HDRS, Clinical Global Impression (CGI) scores | |
Notes | Funding: unclear | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "randomised schedule". No other information provided |
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 | Unclear if raters were independent and unclear if blinding was successful |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Double blind, no further information |
Incomplete outcome data (attrition bias) All outcomes | High risk | Number of drop‐out reported, but unclear reasons for dropout. Rating scale scores reported without denominators. Vital signs and side effects not reported |
Selective reporting (reporting bias) | Unclear risk | No secondary endpoint scores. No standard deviations reported for HDRS score |
Other bias | Unclear risk | Funding: unclear |