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. |
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Interventions | Fluoxetine: 8 participants
Mirtazapine: 8 participants
Fluoxetine dose range: 20‐40 mg/day Mirazapine dose range: 15‐45 mg/day |
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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 |