Preskorn 1983.
Methods | 6‐week, double‐blind, randomised, multi‐centre study, placebo wash‐out unclear | |
Participants | Psychiatric inpatients meeting DSM‐III criteria for major depressive disorder, threshold baseline severity not reported Age: range (of all allocated patients) 18 to 82 years Sex: no data Exclusion criteria: recent alcohol or drug abuse, schizophrenia, organic brain syndrome, seizure disorder, pregnancy, severe medical illness, medical contraindications to amitriptyline chemotherapy |
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Interventions | Amitriptyline: number of participants unclear Placebo: number of participants unclear Amitriptyline dose: ascending dosage regimen, doses not reported |
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Outcomes | Primary outcome: plasma concentrations, HAM‐D Secondary outcome: Anxiety Rating Scale |
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Notes | Sponsor: NIH Research Scientist Development Award, Burroughs Wellcome Company (Bupropion) Response: no definition, no data Remission: no definition, no data 3‐arm study comparing bupropion to amitriptyline and placebo (total 61 participants) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method not described, assumed, because it is a double‐blind study |
Allocation concealment (selection bias) | Unclear risk | Method not described |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "Multi‐centre double‐blind study", no further details |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "Multi‐centre double‐blind study", no details on blinding of assessor |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Drop‐outs not indicated, unclear whether there were any |
Selective reporting (reporting bias) | High risk | Only data for bupropion‐treated patients reported |
Other bias | Low risk | No obvious other bias |