Beasley 1993a.
Methods | Six‐week double‐blind, randomised study | |
Participants | Inpatients fulfilling DSM‐III‐R criteria for major depressive episode, with a score of at least 20 on the Hamilton Rating Scale for Depression‐21 item (HDRS‐21). Age range: 18‐70 years Exclusion criteria: psychosis, organic mental disorder, substance abuse active within 1 year | |
Interventions | Fluoxetine: 56 participants Imipramine: 62 participants Fluoxetine dose range: 40‐80 mg/day Imipramine dose range: 150‐300 mg/day Chloral hydrate (max 1g) and flurazepam (max 30 mg) were allowed as hypnotic | |
Outcomes | HDRS‐21, Raskin, Covi, Clinical Global Impression Severity and Improvement Scales (CGI) | |
Notes | Response: decrease of at least 50% in the total score Remission: total score less than 7 One patient on fluoxetine committed suicide Funding: by industry | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "randomly assigned", 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 | Quote: "efficacy data were analysed in accordance with ITT principle", but scores reported without denominator. Study completion rates and reasons for study discontinuations reported |
Selective reporting (reporting bias) | Unclear risk | Only side‐effect over 5% reported. Vital signs reported |
Other bias | High risk | Authors' affiliation was Psychopharmacology Division, Lilly Reasearch Laboratories, Eli Lilly and Company, Indianapolis. This company produces fluoxetine |