Methods |
A randomised, double‐blind, placebo‐controlled trial of duloxetine in people with major depressive disorder and painful physical symptoms |
Participants |
Adult (18 years of age) male or female outpatients were eligible ...if they met all of the following: a current episode of major depressive disorder according to the DSM‐IV‐TR and confirmed by the MINI with a history of at least one separate, previous episode of depression, and at both the screening and randomisation visits a MADRS total score of 20, and at least moderate pain with a score of 3 on the Brief Pain Inventory Short Form (BPI) average pain item, and a Clinical Global Impression of Severity (CGI‐S) score 4. Painful symptoms were not allowed to have an identifiable underlying cause |
Interventions |
Duloxetine 60 mg once daily orally for 8 weeks vs placebo |
Outcomes |
|
Notes |
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Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
'Randomised' |
Allocation concealment (selection bias) |
Unclear risk |
Unclear |
Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
'Double Blind' |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No concerns |
Selective reporting (reporting bias) |
Low risk |
None |
Other bias |
Low risk |
None identified |