Battegay 1985.
Methods | Seven‐week, double‐blind, randomised study. | |
Participants | Outpatients meeting DSM III endogenous and reactive depression, with a minimum score of 20 on the Hamilton rating scale for depression (HDRS‐17). Age range: 18‐60 years. | |
Interventions | Paroxetine: 11 participants. Amitriptyline: 10 participants. Paroxetine dose range: 10‐30 mg/day. Amitriptyline dose range: 50‐100 mg/day. In case of severe insomnia tranquillisers with a short half life were permitted. |
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Outcomes | HDRS‐17, Montgomery and Asberg Depression Rating Scale (MADRS), Clinical Global Impression (CGI). Dropout, number of patients experiencing at least one side effect, side‐effect profile. |
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Notes | Small sample; more than 50% of patients did not complete the trial. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "the patients received (...) in a randomized procedure (...)". No further details. |
Allocation concealment (selection bias) | Unclear risk | No informations provided. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "the patients received in a double blind procedure identically looking white tablets containing either 10 mg paroxetine ore 50 mg amitriptyline". |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "double blind". |
Incomplete outcome data (attrition bias) All outcomes | High risk | Study endpoint: 3/11 missing from paroxetine group; 8/10 missing from control group. |
Selective reporting (reporting bias) | High risk | Standard deviations of change scores for depression were not reported. |
Other bias | Unclear risk | Sponsorship bias cannot be ruled out. |