Schatzberg 2006.
Methods | Eight‐week randomised, double‐blind study | |
Participants | Outpatients fulfilling DSM‐IV criteria for unipolar depression (single or recurrent, nonpsychotic) with a current episode of at least 4 weeks in duration; had a score of at least 20 on the Hamilton Rating Scale for Depression‐21 item (HDRS‐21). Age: 65 years Exclusion criteria: bipolar disorder, psychotic disorder not related to depression, current substance abuse or substance dependence within the past year, current suicidal intent, at least 18 at the MMSE score, have received treatment with fluoxetine or venlafaxine in the past six months, electroconvulsive therapy within 3 months serious medical disease, suicidal patients, history of alcohol or substance abuse, any investigational drug or antipsychotic drug within the prior 30 days, use of astemizole, cisapride, sumatriptan, terfenadine, paroxetine, sertraline, or any monoamine oxidase inhibitor within 14 days, use of other antidepressant, anxiolytic, sedative‐hypnotic drug, or any other psychotropic drug or substance within 7 days, patients with a known hypersensitivity to venlafaxine or fluoxetine, renal or hepatic disease, seizure disorder or myocardiac infarction within the prior 6 months, and patients with a severe, acute or unstable medical illness. | |
Interventions | Fluoxetine: 100 participants Venlafaxine: 104 participants Placebo: 96 participants Fluoxetine dose range: 20‐60 mg/day Venlafaxine dose range: 75‐225 mg/day |
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Outcomes | Decrease in HDRS‐21 score, Montgomery–Åsberg Depression Rating Scale (MADRS) score and Clinical Global Impression (CGI) score. Response: decrease of at least 50% HDRS score from baseline to endpoint |
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Notes | Funding: by industry | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "randomisation was by number in six‐patients unit with equal numbers of each treatment", no other information about the randomisation procedures |
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 | Quote: "medication for each patient was packaged individually and code‐labelled with the study number and a unique patient randomisation number. Units were distributed to study sites according to the lowest available randomisation number", no further information |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "medication for each patient was packaged individually and code‐labelled with the study number and a unique patient randomisation number. Units were distributed to study sites according to the lowest available randomisation number", no further information |
Incomplete outcome data (attrition bias) All outcomes | High risk | Number and reasons for dropout described. Number of responders is reported only in figures and in percentage. Endpoint scores not reported |
Selective reporting (reporting bias) | Unclear risk | Baseline scores reported without standard deviation. Side effects reported |
Other bias | High risk | Quote: "funding for this study provided by Wyeth Research", and this company produces venlafaxine |