Skip to main content
. 2014 Jan 3;2014(1):CD007115. doi: 10.1002/14651858.CD007115.pub3

Gaynor 2011b.

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
  • BPI at 8 weeks

  • Patient reported global impression of improvement

  • Sheehan Disability Scale global functional impairment score

Notes  
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