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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 followed by a 1 week, single-blind, down-titration period
Participants Outpatients meeting DSM-IV criteria for Major Depressive Disorder, having a minimum score of 18 on Montgomery-Asberg Depression Rating Scale (MADRS).
Age range: 18-85 years.
Exclusion criteria: history of mania or any bipolar disorder, schizophrenia or any psychotic disorder, currently obsessive-compulsive disorder, eating disorders, mental retardation, any pervasive development disorder or cognitive disorder, MADRS score >= 5 on item 10, alcohol or drug abuse problems within the past 12 months, concomitant treatment with antipsychotics, antidepressants, psychotropics, serotonin receptor agonists, lithium, carbamazepine, valproate, valpromide, electroconvulsive treatment, behaviour treatment or psychotherapy, pregnancy, breast feeding, use of medications thought likely to interfere with the study
Interventions Escitalopram: 148 participants.
Venlafaxine XR: 145 participants.
Escitalopram dose range: 10-20 mg/day.
Venlafaxine XR dose range: 75-150 mg/day.
Zolpidem or stable low doses of Benzodiazepines for insomnia were allowed
Outcomes Primary Outcome: Change from baseline to week 8 in Montgomery-Asberg Depression Rating Scale.
Secondary Outcomes: Hamilton Depression Rating Scale (24 item and 17 item), HAMD Subscale Scores (anxiety/somatization, psychomotor retardation, sleep disturbance, cognitive disturbance and melancholia), Clinical Global Impression - Improvement, Clinical Global Impression - Severity
Notes Remission: a score equal or less than 12 on MADRS.
This study was funded by escitalopram manufacturer.
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Yes Quote: “randomized”. Probably done
Allocation concealment? Unclear No information provided
Blinding?
All outcomes
Unclear No information provided
Incomplete outcome data addressed?
All outcomes
Yes Quote: “ITT population included all randomized patients who took at least one dose of double-blind study product and who had at least one valid post-baseline MADRS assessment.”
Free of selective reporting? No