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. 2013 Jul 17;2013(7):CD004185. doi: 10.1002/14651858.CD004185.pub3

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