Methods | Eight-week, double-blind, randomised, multicentre study. | |
Participants | Outpatients meeting DSM-IV criteria for Major Depressive Disorder with an ongoing episode and having a minimum score of 22 on Montgomery-Asberg Depression Rating Scale (MADRS). Age range: 18-80 years. Exclusion criteria: significant abnormalities from physical examination, laboratory tests and electrocardiogram (ECG), pregnancy, female patients of childbearing potential that were not using a medically accepted form of contraception, lactation, a primary Axis I disorder other than MDD, a history of any DSM-IV-definied psychotic disorder, substance abuse or dependency, risk of suicide, any personality disorder considered to be of sufficient severity to interfere with participation in the study, use of a depot neuroleptic within the past 6 months, use of any neuroleptic, antidepressant or anxiolytic medication within the past 2 weeks (5 weeks for fluoxetine), previous treatment with either escitalopram or sertraline, previous failure to respond to adequate trials of any two SSRIs, previous participation in an investigational study within the past month or previous treatment with an investigational drug within the past month (or five half-lives of the drug, whichever was longer), concomitant use of any psychotropic drug (or any drug with a psychotropic component) |
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Interventions | Escitalopram: 107 participants. Sertraline: 108 participants. Escitalopram dose: 10 mg/day. Sertraline dose range: 50-200 mg/day. Zolpidem or zaleplon for sleep were allowed. |
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Outcomes | Primary Outcome: Change from baseline to week 8 in Montgomery-Asberg Depression Rating Scale. Secondary Outcomes: Hamilton Depression Scale- 24 item, Clinical Global Impression - Improvement, Clinical Global Impression - Severity |
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Notes | This study was funded by escitalopram manufacturer. | |
Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Yes | Quote: “randomized”. Probably done |
Incomplete outcome data addressed? All outcomes |
Yes | ITT population (at least one dose of study medication and at least one post-baseline MADRS assessment) using the LOCF approach |
Free of selective reporting? | Yes |