Berlanga 2006.
Methods | Eight‐week double‐blind clinical trial. | |
Participants | Patients between 18 and 40 years, meeting the DSM‐IV criteria for Major Depressive Disorder after two independent clinical interviews, and scoring at least 18 in the 21‐item Hamilton Depression Rating Scale (HDRS). Patients were excluded if psychotic symptoms were present or a history of past manic, hypomanic or mixed episodes was confirmed. Also participants with uncontrolled medical illnesses, evidence of drug abuse or severe personality disorders were not included. In the case of women individuals with irregular menstrual cycles, pregnancy, breastfeeding, current hormonal treatments and biological or surgical menopause were also excluded. |
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Interventions | Citalopram: 54 participants Reboxetine: 47 participants Citalopram dose range: 20‐40 mg/day (mean dose: 25.8 SD 3.7). Reboxetine dose range: 4‐8 mg/day (mean dose: 5.8 SD 1.5) |
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Outcomes | Change in HDRS scores from baseline to endpoint. | |
Notes | This study was funded by Lundbeck (citalopram manufacturer). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "subjects were randomly assigned to an 8‐week double blind comparative trial with reboxetine or citalopram". Probably done. |
Allocation concealment (selection bias) | Unclear risk | No information provided. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "drugs were administered orally at bedtime using identical capsules containing 4 mg of reboxetine or 20 mg of citalopram as starting doses". |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "comparison were done only with patients having at least five evaluations (basal and four weeks of treatment). In patients who had a minimum of five evaluations but did not complete the 8‐week of follow‐up, Last Observation Carried Forward (LOCF) procedure was used. |
Selective reporting (reporting bias) | High risk | Continous data about the two groups are missing. The paper reported only data for men or for women. |
Other bias | Unclear risk | Sponsorship bias cannot be ruled out. |