| Methods |
Six‐week randomised, double‐blind study |
| Participants |
In‐ and outpatients fulfilling DSM‐III‐R criteria for major depressive disorder or bipolar disorder (currently depressive), with a score of at least 17 on the Hamilton Rating Scale for Depression‐17 item (HDRS‐17).
Age range: 18‐70 years
Exclusion criteria: previous use of fluoxetine or lofepramine prior entry to study or during present episode, use of psychoactive drugs (a part from short acting benzodiazepines within 7 days prior entry), use of MAOI within 14 days and depot neuroleptics within 6 months, ECT, serious suicide risk, pregnancy, lactation, absence of contraception, history of glaucoma, cardiovascular disease or urinary retention, significant other medical illness, history of severe allergies or multiple adverse drug reaction, concurrent use of diuretics. |
| Interventions |
Fluoxetine: 90 participants
Lofepramine: 93 participants
Fluoxetine dose: 20 mg/day
Lofepramine dose range: 140‐210 mg/day |
| Outcomes |
HDRS‐17, Montgomery and Asberg Scale for Depression (MADRS) |
| 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: "blindness was maintained by having each subject on lofepramine taking placebo‐fluoxetine in addiction and vice versa", 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 |
High risk |
Reasons and number of dropouts reported. Scores reported with denominator |
| Selective reporting (reporting bias) |
Unclear risk |
Adverse events experienced by more than five subjects in either group were reported. Scores reported only in figures and without standard deviation |
| Other bias |
High risk |
One author's affiliation was Lilly Industries Ltd, and this company produces fluoxetine |
