29060III/85/038.
Methods | A double‐bind, parallel group, active controlled, double‐dummy, randomised study. | |
Participants | Participants suffering from either reactive or endogenous unipolar depression considered suitable for treatment with "tricyclic‐like" antidepressants were eligible for the study. Participants had to score al least 17 on the first 17‐itemof the Hamilton rating scale for depression (HDRS‐21) and fulfil the DSM‐III criteria for the diagnosis of depression. Subjects were excluded in they were suffering from severe co‐existing diseases, intolerant to "tricyclic‐like" drugs, scored 4 on the suicide item of the HDRS‐21, had received ECT in the previous 3 months required hospitalisation for ECT treatment, had taken IMAO with 2 weeks of the active phase of the study and female participants who were pregnant or lactating. Age range: 18‐70 years old. |
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Interventions | Paroxetine: 30 participants. Mianserin: 29 participants. Paroxetine dose range: 15‐30 mg/day Mianserine dose range: 30‐90 mg/day. |
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Outcomes | HDRS‐21, Clinical Global Impression (CGI). Total dropout, dropout due to side effects, dropout due to inefficacy. Number of patients experiencing at least one side effect, side‐effect profile. | |
Notes | None. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "subjects were randomized (...) allocation of treatment by random code". |
Allocation concealment (selection bias) | Unclear risk | No information provided. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "double blind, using a double dummy technique". No further details. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "double blind, using a double dummy technique". No further details. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "results are presented for the Intention‐to‐treat (ITT) population, extender data set". Less than 20% of participants in each study arm abandoned the study prematurely. |
Selective reporting (reporting bias) | Low risk | Outcomes data were reported. |
Other bias | Unclear risk | Sponsorship bias cannot be ruled out. |