Methods |
Eight‐week randomised, double‐blind multicentre study |
Participants |
Outpatients fulfilling DSM‐III criteria for moderate to severe major depressive disorder, non psychotic, with a score of at least 18 on the first 17 items of the Hamilton Rating Scale for Depression‐17 item (HDRS‐17).
Age range: 19‐55 years
Exclusion criteria: engaged in a shift work, independent sleep/wake disorders, significant concurrent general medical conditions, DSM‐III criteria for psychoactive use disorder within 1 year prior to study, other major lifetime Axis I disorders (organic mental syndrome, bipolar, any psychotic, any eating,panic or obsessive‐compulsive disorder), pregnancy, lactation, absence of contraception. |
Interventions |
Fluoxetine: 61 participants
Nefazodone: 64 participants
Fluoxetine dose range: 20‐40 mg/day
Nefazodone dose range: 200‐500 mg/day |
Outcomes |
HDRS‐17 total score, Inventory of Depressive Symptomatology (IDS), Clinical Global Impression (CGI) Improvement |
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: "double dummy dosing regimen was employed", 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 dropout reported. Scores reported with denominator |
Selective reporting (reporting bias) |
Unclear risk |
Only most common side effects reported |
Other bias |
High risk |
Quote: "this study was sponsored by Bristol‐Myers Squibb Pharmaceutical research Institute", this company produces nefazodone |