Sheehan 2009.
Methods | Six‐week randomised, double‐blind multicentre study | |
Participants | Inpatients fulfilling DSM‐IV criteria for the melancholic subtype of MDD of at least 1 month duration, with a score of at least 24 on the first 21 items of the Hamilton Rating Scale for Depression (HDRS‐21). (In patients at the moment of randomisation, then patients could complete the protocol as outpatients if, in the opinion of the investigator, the response to treatment was sufficient to allow discharge from hospital). Age range: adults, over 18 years old Exclusion criteria: severe or poorly controlled medical illnesses, known hypersensibility to either study drug, treatment with either study drug within 3 months, or myocardial infarction within 6 months before the start of the study, patients with clinically significant abnormalities on the physical examination, electrocardiogram, laboratory tests, or urine test, pregnancy, lactation, absence of contraception. Patients with active suicidal ideation, history of seizures, the presence or history of an organic mental disorder, mania or hypomania or psychotic disorder; electroconvulsive therapy within 3 months, any investigational or antipsychotic drug within 30 days, or astemizole, cisapride, sumatriptan, terfenadine, or any monoamine oxidase inhibitor within 14 days; patients could not have taken any other antidepressant, anxiolytic, sedative‐hypnotic, or other psychotropic drug within 2 days before the start of double blind treatment; any non psychopharmacological drug with psychotropic effects in the last 2 days, and history of alcohol or drug dependence or abuse within 1 year before double‐blind treatment. | |
Interventions | Fluoxetine: 99 participants Venlafaxine: 95 participants Fluoxetine dose range: 60‐80 mg/day Venlafaxine dose range: 225‐375 mg/day |
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Outcomes | Hamilton Rating Scale for Depression (HDRS‐21) total score, Clinical Global Impression (CGI) Improvement , Montgomery–Åsberg Depression Rating Scale (MADRS) total score Response: decrease of at least 50% in the total score on the HDRS and MADRS, or a score of 1‐2 on the CGI‐I |
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Notes | Funding: by industry | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "patients were enrolled by investigators and assigned to blinded treatment by a computerized randomisation process generated by the sponsor. Medication was randomised in blocks of six patients, lots containing equal numbers of each treatment." |
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 | Double blind, no further information |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Double blind, no further information |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Number and reasons for withdrawal reported. Scores reported with denominators. Mean scores (HDRS, MADRS, CGI) and standard deviations reported clearly at baseline and at the endpoint |
Selective reporting (reporting bias) | Unclear risk | Only most common (10%) side effects reported |
Other bias | High risk | Quote: "this study was funded by Wyeth Pharmaceuticals and administered by Quitiles", and this company produces venlafaxine |