Mao 2008.
Methods | Eight‐week randomised, parallel group, double‐blind study | |
Participants | In‐ and outpatients fulfilling DSM‐IV criteria for major depressive disorder, with a score of at least 18 on the first 17 items of Hamilton Rating Scale for Depression (HDRS) and a score of at least 4 on Clinical Global Impression‐Severity (CGI). Age range: 18‐65 years Exclusion criteria: any current primary DSM‐IV axis I diagnosis or any anxiety disorder as a primary diagnosis within the year preceding enrolment, or schizoaffective disorder, a history of substance abuse or dependence within the past year; serious suicidal risk or serious medical illness; currently take St. John's wort or other Chinese herbal medicine for depression were also excluded. |
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Interventions | Fluoxetine: 117 participants Escitalopram: 123 participants Fluoxetine dose: 10 mg/day Escitalopram dose: 20 mg/day | |
Outcomes | Primary outcome: change in HDRS total score Secondary outcome: change in Montgomery and Asberg Scale for Depression (MADRS) total score Response: at least 50% decrease from HDRS baseline score |
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Notes | Funding: by industry | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised, no further information |
Allocation concealment (selection bias) | Unclear risk | No information provided |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Double blind, no further information |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: " we administered treatments in a double blind fashion using a double‐dummy design", no further information |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Double blind, no further information |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Number and reasons for discontinuation clearly reported. Denominator reported for responders was different from the number of randomised patients |
Selective reporting (reporting bias) | Unclear risk | Side effects reported. Secondary endpoint scores (MADRS, CGI) reported |
Other bias | High risk | Quote: "contract grant sponsor: Xian‐Janssen Pharmaceutical Company (honoraria to authors for conducting this trial)". This company produces escitalopram |