CL3‐024.
Methods | Six‐week double‐blind, randomised, multicentre study | |
Participants | In‐ and outpatients fulfilling DSM‐IV criteria for single or recurrent episode of Major Depressive Disorder (MDD), with or without melancholic features, without atypical features, without psychotic features and a score of at least 22 on Hamilton Rating Scale for Depression (HDRS). Age range: 18‐59 years Exclusion criteria: not specified |
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Interventions | Fluoxetine: 148 participants
Agomelatine 25mg: 150 participants Agomelatine 50mg: 151 participants Fluoxetine dose: 20 mg/day Agomelatine dose range: 25‐50 mg/day |
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Outcomes | Primary outcome: HDRS score | |
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 other information |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Double blind, no other information |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Double blind, no other information |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Insufficient information |
Selective reporting (reporting bias) | Unclear risk | Insufficient information |
Other bias | High risk | Funding: by industry |