Bougerol 1997a.
Methods | Eight‐week double‐blind, multicentre study in a psychiatrist setting. | |
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 Depression Rating Scale (MADRS). Age range: 18‐65 years old. 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 2 weeks prior to entry the trial, hypersensitivity to study drugs, suicide risk. | |
Interventions | Fluoxetine: 158 participants. Citalopram: 158 participants. Fluoxetine dose: 20 mg. Citalopram dose range: 20‐40 mg/day. Concomitant psychotropic medication was prohibited, but use of benzodiazepines for insomnia was allowed. | |
Outcomes | Primary outcome: MADRS. Secondary outcomes: Hamilton Depression Rating Scale (HDRS‐17), Clinical Global Impression (CGI). | |
Notes | Three attempted suicides in citalopram group, and three attempted suicides in fluoxetine group. This study was funded Lundbeck (citalopram manufacturer). |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No clear data provided |
Allocation concealment (selection bias) | Unclear risk | No data provided |
Blinding (performance bias and detection bias) All outcomes | Low 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 | Low 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) | High risk | Some endpoint scores and baseline scores are missing. |
Other bias | Unclear risk | Sponsorship bias cannot be ruled out. |