Andreoli 2002.
Methods | Eight‐week double‐blind, randomised multicentre study | |
Participants | In and outpatients meeting DSM‐III‐R diagnostic criteria for major depression, with a minimum baseline score of 22 on the Hamilton Rating Scale for Depression‐21 item (HDRS‐21), recruited from 33 clinical sites. Age range: 18‐65 years Exclusion criteria: history of unresponsiveness to antidepressant treatment, association with endocrine disorders, substance abuse, drug hypersensitivity, chronic respiratory insufficiency, or gastro‐intestinal, hepatic or renal disease, ECT within 6 months of baseline, high risk of suicide, pregnancy or absence of adequate contraception measures. | |
Interventions | Fluoxetine: 127 participants Reboxetine: 126 participants Placebo: 128 participants Fluoxetine dose range: 20‐40 mg/day Reboxetine dose range: 8‐10 mg/day Chloral hydrate (0.5‐1 g) was allowed as hypnotic | |
Outcomes | Primary outcome: absolute change in the HDRS‐21 total score Secondary outcomes: Clinical Global Impression Scale (CGI) Severity and Improvement, Montgomery and Asberg Scale for Depression (MADRS), Quality of Sleep Questionnaire | |
Notes | Response: decrease of at least 50% in the HDRS total score Remission: total score less than 10 Funding: unclear | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised trial, no further information |
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 | Unclear risk | Number of randomised and number of lost during follow‐up reported, but the reasons for dropout were not clear. Only most common side effects were reported Quote: "Statistical analysis was carried out on the intent to treat population" |
Selective reporting (reporting bias) | Unclear risk | Only most common side effects were reported Mean endpoint scores and standard deviation reported |
Other bias | Unclear risk | Funding: unclear |