Massana 1999.
Methods | Six‐week randomised, double‐blind, multicentre study | |
Participants | In‐ and outpatients fulfilling DSM‐III‐R criteria for depressive episode (lasting between 1 to 8 months), without psychotic features, with a score of at least 22 on the Hamilton Rating Scale for Depression (HDRS). Age range: 18‐65 years Exclusion criteria: pregnancy, absence of contraception, dysthymia/cyclothymia, substance abuse disorder, high risk of suicide, resistance to antidepressant treatment, history of major depressive disorder associated with endocrine disorder and/or drug hypersensitivity, chronic respiratory insufficiency, a history of seizures or brain injury, a history or current evidence of any other important clinical condition or use of electroconvulsive therapy in the previous 6 months. | |
Interventions | Fluoxetine: 89 participants
Reboxetine: 79 participants
Fluoxetine dose range: 20‐40 mg/day
Reboxetine dose range: 8‐10 mg/day Chloral hydrate (0.5‐1 mg) for sleep |
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Outcomes | Primary outcome: change in the HDRS total score, number of patients showing response (decrease of at least 50% in HDRS total score) and remission (a final score of 10 or less) Seconday outcomes: Clinical Global Impression‐Severity (CGI‐S), Montgomery and Asberg Scale for Depression (MADRS), Patient Global Impression (PGI) |
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Notes | Funding: unclear | |
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 | 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 | High risk | Number of withdrawals reported, but reasons for dropout not clearly described. Scores reported without denominator |
Selective reporting (reporting bias) | Unclear risk | SIde effects not clearly reported. Mean endpoint scores reported with standard deviation |
Other bias | Unclear risk | Funding: unclear |