Skip to main content
. 2012 Jul 11;2012(7):CD006534. doi: 10.1002/14651858.CD006534.pub2

Burke 2002.

Methods Eight‐week, double‐blind, randomised, parallel group, multicentre study.
Participants Outpatients meeting DSM‐IV criteria for Major Depressive Disorder, having a minimum score of 22 on Montgomery‐Asberg Depression Rating Scale (MADRS) and a minimum score of 2 on Item 1 of Hamilton Depression Rating Scale (HDRS). 
 Age range: 18‐65 years. 
 Exclusion criteria: any DSM‐IV Axis I disorder other than major depression, any personality disorder, a history of substance abuse, a suicide attempt within the past year or evidence of active suicidal ideation (as indicated by a score of at least 5 on item 10 of the MADRS), pregnancy, lactation, women of childbearing potential if they didn't agree to use a medically acceptable method of contraception, concomitant psychotropic medication.
Interventions Escitalopram: 252 participants. 
 Citalopram: 127 participants. 
 Escitalopram dose range: 10‐20 mg/day. 
 Citalopram dose: 40 mg/day. 
 Zolpidem for insomnia was allowed (no more than three times per week).
Outcomes Primary Outcome: Change from baseline to week 8 in MADRS, HDRS‐24, HDRS Depressed Mood Item, Clinical Global Impression‐Improvement (CGI‐I), Clinical Global Impression‐Severity (CGI‐S). 
 Secondary Outcomes: change in Hamilton Rating Scale for Anxiety (HAM‐A), Center for Epidemiological Studies‐Depression Scale (CES‐D), Quality of Life Questionnaire (QOL) and a 16‐item instrument derived from the QOL enjoyment and satisfaction questionnaire from baseline to endpoint.
Notes This study was funded by escitalopram manufacturer.
One suicide attempted in escitalopram 20 mg group. One intentional overdose in placebo group. One non‐intentional overdose in citalopram 40 mg group.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Patients meeting eligibility criteria at a screening visit entered a 1‐week, single blind, placebo lead‐in period, returning for a baseline visit at the end of the lead‐in period. Patients completing the placebo lead‐in, who continued to meet all entry criteria, were then randomly assigned to receive 8 weeks of double blind treatment".
Allocation concealment (selection bias) Unclear risk No information provided.
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk Quote: "in order to maintain the blind, all double blind study medication was administered as one capsule per day, regardless of dose of treatment group. No further adjustment of dosage was permitted".
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Quote: "Efficacy was assessed in the Intention‐to‐treat (ITT) population which included all patients who had received at least 1 dose of double blind study medication and had at least 1 post‐baseline MADRS assessment".
Selective reporting (reporting bias) Low risk Remission rate are missing.
Other bias Unclear risk Sponsorship bias cannot be ruled out.