McGrath 2000.
| Methods | Ten‐week randomised, double‐blind, multicentre study | |
| Participants | Patients fulfilling DSM‐IV criteria for major depressive episode, lasting for at least 1 month and having Columbia criteria for atypical depression. Age range: 18‐65 years Exclusion criteria: significant suicidal risk, pregnancy, lactation, absence of contraception, unstable and serious physical illness, history of seizures, psychosis or organic mental syndrome, substance use disorder within 6 months, history of mania, antisocial personality disorder, history of non‐response to an adequate trial of fluoxetine or imipramine, history of no response to any other SSRIs, hypothyroidism. | |
| Interventions | Fluoxetine: 49 participants Imipramine: 53 participants Placebo: 52 participants Fluoxetine dose range: 20‐60 mg/day Imipramine dose range: 50‐300 mg/day | |
| Outcomes | Hamilton Rating Scale for Depression (HDRS), Clinical Global Impression (CGI) | |
| Notes | Funding: by industry | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomised, 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 | Quote: "all patients received identical capsules", 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 drop out was reported; reasons for dropout were not clearly stated Quote: "in the analyses to follow‐up, we will focus on the ITT group to estimate treatment effects without bias related to attrition", unclear how this analysis was carried out |
| Selective reporting (reporting bias) | Unclear risk | Side effects reported. Only endpoint adjusted scores reported |
| Other bias | High risk | Quote: "supported by Eli Lilly and Company", this company produces fluoxetine |