Nielsen 1991.
Methods | Double‐blind, randomised, multicentre study. | |
Participants | Inclusion criteria were depression (unipolar or bipolar) calling for pharmacotherapeutic treatment, Hamilton rating scale for depression (HDRS) 18+, age 18‐70 years and all patients met the DSM‐III criteria for major depressive episode. Exclusion criteria were concurrent somatic conditions contraindicating treatment with antidepressants, i.e. cardiovascular conditions, severe liver or renal disease, severe hypertension and unstable endocrinological disease. |
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Interventions | Paroxetine: 16 participants. Imipramine: 15 participants. Paroxetine dose: 30 mg/day. Imipramine dose: 150 mg/day. Concomitant medications was restricted to occasional doses of oxazepam (or similar benzodiazepines) as sedative and paracetamol as analgesic, when necessary. Other psychotropic medication, including lithium, was not allowed. |
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Outcomes | HDRS‐17, Melancholia Scale (MES), UKU scale. Total dropout, dropout due to side effects, dropout due to inefficacy. Number of patients experiencing at least one side effect. | |
Notes | Funding unclear. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "the patients were randomly allocated". No further details. |
Allocation concealment (selection bias) | Unclear risk | No information provided. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "double blind". No further details. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "double blind". No further details. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "to reduce bias caused by patient withdrawals, the last value was carried forward in the analyses". More than 20% of participants in both arms withdrew from the study prematurely. |
Selective reporting (reporting bias) | High risk | Side effects were not reported. Continuous outcomes only in graph. |
Other bias | Unclear risk | Sponsorship bias cannot be ruled out. |