Skip to main content
. 2013 Jul 17;2013(7):CD004185. doi: 10.1002/14651858.CD004185.pub3

Winokur 2003.

Methods Eight‐week double‐blind randomised study
Participants Patients fulfilling DSM‐IV criteria for major depressive disorder (based on a semi structured clinical interview), a score of at least 18 on the Hamilton Rating Scale for Depression‐21 item (HDRS‐21) and a score of at least 4 on the 3 HDRS‐21 sleep item.
Age range: 18‐75 years
Exclusion criteria: patients with an history of primary sleep disorder, significant medical problems, current alcohol or substance abuse or dependence, psychosis, or suicidal ideation. Psychotropic drugs were discontinued at least 1 week before study initiation and no subject received any prolonged‐acting central nervous system agent during the previous month.
Interventions Fluoxetine: 8 participants
 Mirtazapine: 8 participants
 Fluoxetine dose range: 20‐40 mg/day
Mirazapine dose range: 15‐45 mg/day
Outcomes Change in the HDRS‐21 score and in Clinical Global Impression (CGI) score
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, double dummy, no further information
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Double blind, double dummy, no further information
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Double blind, double dummy, no further information
Incomplete outcome data (attrition bias) 
 All outcomes High risk Number and reasons for dropout not clearly reported
Only HDRS baseline scores reported
Selective reporting (reporting bias) High risk Side effects not reported. Number of responders not reported
Other bias High risk Quote: "funds for this study were provided through on unrestricted educational grant from Organon, Inc" and this industry produces venlafaxine