de Wilde 1985.
Methods | Six‐week controlled, double‐blind, randomised trial. | |
Participants | In‐patients suffering from endogenous depression or chronic dysthymic disorder (Spitzer's research Diagnostic Criteria), with a total score of at least 25 on the 10‐item Comprehensive Psychopathological Rating Scale (CPRS) sub‐scale for depression. Age range: 18‐70 years Exclusion criteria: pregnancy/lactation, serious somatic disease (particularly of the heart, liver or kidneys), organic brain syndrome, need for ECT, abuse of alcohol or drugs, and treatment with MAO inhibitors within the previous 3 weeks. |
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Interventions | Citalopram: 30 participants Mianserin: 30 participants Citalopram dose range: 40‐80 mg/die Mianserin dose range:60‐120 mg/die Additional medication with benzodiazepine as sedatives/hypnotics was permitted. |
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Outcomes | Primary outcome: mean change at endpoint on the 10‐item CPRS sub‐scale for depression and on Clinical Global Impression ‐ Severity (CGI‐S). | |
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: " Patients were randomly allocated". Probably done. |
Allocation concealment (selection bias) | Unclear risk | No information provided. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "double blind treatment with either citalopram or mianserin, administered as identically looking capsules". |
Incomplete outcome data (attrition bias) All outcomes | High risk | Observed‐case (completers) analysis only |
Selective reporting (reporting bias) | High risk | No reliable data about response rate. |
Other bias | Unclear risk | Sponsorship bias cannot be ruled out. |