Amini 2005.
Methods | Six‐week double‐blind randomised trial | |
Participants | In and outpatients meeting DSM‐IV diagnostic criteria for major depression, with a minimum baseline score of 18 on the Hamilton Rating Scale for Depression‐17 item (HDRS‐17). Age range: 18‐60 years Exclusion criteria: history of recent suicidal attempt (1 month or less before the study) or actual ideation; pregnancy or lactation; history or current diagnosis (DSM‐IV) of dysthymic disorder, bipolar disorder, any psychotic disorder, eating disorders, personality disorders and mental retardation; current diagnosis (DSM‐IV) of anxiety disorders (except for specific phobia), mental disorder due to general medical condition, substance or alcohol abuse or dependency (except for nicotine and caffeine) and postpartum depression; current diagnosis of any serious systemic medical illnesses; treatment with any antidepressant drugs within 1 week, or with MAOIs within 5 weeks, or electroconvulsive therapy within 3 months ago; BMI more than 30 and white blood count more than 4000/mm or neutrophil more than 1500/mm. | |
Interventions | Fluoxetine: 18 participants
Mirtazapine: 18 participants
Fluoxetine dose: 20 mg/day Mirtazapine dose: 30 mg/day |
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Outcomes | Mean decrease in HDRS‐17 score from baseline | |
Notes | 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 | Quote: "A observed cases analysis over the 6 weeks was the primary efficacy analysis (...) an intention to treat analysis with LOCF was also performed...all discussion of result is based on observed cases (OC) analysis". Number of randomised, and number of lost during the follow‐up reported. Number of responders reported without denominator |
Selective reporting (reporting bias) | Unclear risk | Side‐effects are reported. Vital signs and body weight not reported Mean endpoint scores (HDRS) reported in figures and without standard deviations |
Other bias | Unclear risk | Funding: unclear |