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. Author manuscript; available in PMC: 2014 Sep 15.
Published in final edited form as: Cochrane Database Syst Rev. 2009 Apr 15;(2):CD006532. doi: 10.1002/14651858.CD006532.pub2
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)
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.
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
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