| Methods |
Eight‐week double‐blind, multicentre study |
| Participants |
In‐ and outpatients fulfilling DSM‐III‐R criteria for a major depressive disorder or bipolar disorder. The severity of depression should be 25 or more on the Montgomery and Asberg Scale for Depression (MADRS).
Age range: 18‐65 years
Exclusion criteria: pregnancy, lactation, failure to use a safe contraceptive method, alcohol or drug abuse within the last year, patients with severe somatic, neurological or psychiatric disease, treatment with MAOI within 2 weeks prior to entry the trial, hypersensitivity to study drugs, suicide risk. |
| Interventions |
Fluoxetine: 158 participants
Citalopram: 158 participants
Fluoxetine dose: 20 mg/day
Citalopram dose range: 20‐40 mg/day
Concomitant psychotropic medication was prohibited, but use of benzodiazepines for insomnia was allowed |
| Outcomes |
Primary outcome: MADRS score
Secondary outcomes: Hamilton Rating Scale for Depression ‐17 item (HDRS‐17), Clinical Global Impression (CGI) scores |
| Notes |
Funding: by industry |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
No information provided |
| 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 |
Double dummy" 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 |
Quote: "all efficacy analyses were made on the basis of the efficacy group, whereas the tolerability analyses were made on the basis of the ITT population" |
| Selective reporting (reporting bias) |
Unclear risk |
Side effects reported only when recorded in at least 5 patients |
| Other bias |
High risk |
Quote: "sponsored by Lundbeck, Copenaghen. This company also delivered the citalopram tablets and bought (in bulk) the fluoxetine capsules (active and placebo) from Eli LIlly, England, and packed them" |
