Bougerol 1997b.
Methods | Eight‐week, double‐blind, multicentre, parallel group study in general practice. | |
Participants | Outpatients (primary care) fulfilling DSM‐III‐R criteria for a major depressive disorder. The severity of depression should be 22 or more on the Montgomery and Asberg Depression Rating Scale (MADRS).
Age range: 18‐70 years. Exclusion criteria: pregnancy, lactation, failure to use a safetable contraceptive method, alcohol or drug abuse within the last year, patients with severe somatic, neurologic or psychiatric disease, treatment with MAOI within two weeks prior to entry the trial, hypersensitivity to study drugs, suicide risk. |
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Interventions | Fluoxetine: 184 participants. Citalopram: 173 participants. Fluoxetine dose: 20 mg. Citalopram dose: 20 mg/day. Concomitant psychotropic medication was prohibited, but use of benzodiazepines for insomnia. | |
Outcomes | Primary outcome: MADRS. Secondary outcomes: Hamilton Rating Scale for Depression (HDRS‐17), Clinical Global Impression (CGI). | |
Notes | This study was funded Lundbeck (citalopram manufacturer). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "patients were randomized to double blind treatment". Probably done. |
Allocation concealment (selection bias) | Unclear risk | No data provided. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Quote: "due to the different appearance of the two drugs the "double‐dummy" principle was used to blind the study". |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: " patients populations were defined as the Intention‐to‐treat (ITT) group and the Efficacy (EFF) group. The ITT population comprised all randomized patients. The EFF population consisted of all patients who fulfilled the entry criteria and had completed at least 14 days double‐blind treatment. All efficacy analyses were made on the basis of the EFF population". |
Selective reporting (reporting bias) | Unclear risk | Some endpoint scores and baseline scores are missing. |
Other bias | Unclear risk | Sponsorship bias cannot be ruled out. |