Duarte 1996.
Methods | Six‐week randomised, double‐blind study | |
Participants | Outpatients fulfilling DSM‐III‐R criteria for double depression (dysthymia and major depression), with a score of at least 16 on the Hamilton Rating Scale for Depression (HDRS). Age range: 18‐65 years Exclusion criteria: suicidal tendencies, delusional depression, severe organic disease, alcoholism, drug abuse, ongoing ECT or structured psychotherapy. |
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Interventions | Fluoxetine: 21 participants Moclobemide: 21 participants Fluoxetine dose: 20 mg/day Moclobemide dose: 300 mg/day Use of single benzodiazepines was allowed at discretion of the doctor | |
Outcomes | Primary outcomes: percentage of responders defined as decrease of at least 50% in the HDRS Secondary outcomes: endpoint score at HDRS, percentage of end of treatment Clinical Global Impression (CGI) very good and good responses | |
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 | Quote: "double blinding was achieved by appropriate drug packaging and formulation", no further information |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "double blinding was achieved by appropriate drug packaging and formulation", no further information |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "double blinding was achieved by appropriate drug packaging and formulation", no further information |
Incomplete outcome data (attrition bias) All outcomes | High risk | Scores reported without denominators. Mean scores and standard deviations reported only in figure and they were not clear |
Selective reporting (reporting bias) | Unclear risk | No vital signs and side effects reported. Quote: "no clinically significant changes in vitals signs were recorded" |
Other bias | High risk | The last author's affiliation was Hoffmann–La Roche Ltd, and this company produces moclobemide |