Methods |
Eight‐week randomised, double‐blind multicentre study |
Participants |
Outpatients fulfilling DSM‐III‐R criteria for non‐psychotic, moderate to severe major depressive disorder, with a score of at least 18 on the Hamilton Rating Scale for Depression‐17 item (HDRS‐17).
Age range: 21‐55 years
Exclusion criteria: patients engaged in shift work and with a primary sleep disorder independent of affective disturbance, current general medical condition, history of psychoactive substance use disorder within 12 months prior to study entry, current DSM‐III Axis I disorder (organic mental syndrome, bipolar disorder‐depressive, and schizophrenia, delusional disorder, psychotic disorder NOS), pregnancy, lactation, not use of contraception. |
Interventions |
Fluoxetine: 20 participants
Nefazodone: 24 participants
Fluoxetine dose range: 20‐60 mg/day
Nefazodone dose range: 200‐500 mg/day |
Outcomes |
HDRS‐17, Inventory of Depressive Symptomatology (IDS) |
Notes |
Funding: by industry |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Randomised, no information about randomisation procedure |
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 scheme", no other 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 |
Endpoint scores reported without denominators. Number and reasons for discontinuation reported |
Selective reporting (reporting bias) |
Unclear risk |
Only the most frequently occurring adverse events (at least in 10% of patients) reported |
Other bias |
High risk |
Quote: "this study was supported by Bristol‐Myers‐Squibb Pharmaceutical Research Institute", that produces nefazodone |