Martinez 2012.
Methods | Twelve‐week randomised, open study | |
Participants | Outpatients fulfilling DSM‐IV criteria for Major Depressive Disorder (MDD), with a score of at least 16 on the Patient Health Questionnaire (PHQ‐9) at baseline and a score of at least 20 on Quick Inventory of Depression Syntomatology Self‐Report scale (QIDS‐SR) at visit 1 and 2. Exclusion criteria: pregnancy, lactation, absence of contraception. Patients taking an investigational drug (bupriopion, sertraline, venlafaxine, paroxetine, fluoxetine or escitalopram) were allowed to participated only if they had not adequately responded to treatment. Patients with a history of bipolar disorder, primary psychotic disorder, cognitive disorder or obsessive‐compulsive disorder, or current (within last 6 months) primary axis I diagnosis of panic disorder, post‐traumatic stress disorder, generalized anxiety disorder, social anxiety disorder, dysthymia, alcohol or eating disorders were excluded. To be at serious risk of suicide, the presence of a serious, unstable medical illness or clinically significant laboratories abnormality, dementia, mental retardation diagnosis, history of substance abuse or dependence within previous 6 months or positive urine drug screen for any substance of abuse, treatment with electroconvulsive therapy, initiation of psychotherapy within 6 weeks before study entry or during study participation were exclusion criteria. | |
Interventions | Fluoxetine: 57 participants Duloxetine: 372 participants Fluoxetine dose range: 20‐80 mg/day Duloxetine dose range: 30‐120 mg/day | |
Outcomes | Primary outcome: change in QIDS‐SR total score Secondary measures: Hamilton Rating Scale for Depression (HDRS) |
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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 | High risk | Quote: "non‐blinded study" |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "non‐blinded study" |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "non‐blinded study" |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Number and reasons for discontinuation clearly reported. Endpoint mean score reported as a class |
Selective reporting (reporting bias) | Unclear risk | Side effects reported only when occurred in more than 5% of the sample. Mean endpoint scores reported with standard deviation and denominator |
Other bias | High risk | Quote: "funded by Lilly USA, Indianapolis", and this company produces fluoxetine |