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. |
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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. |