Ravindran 1997.
Methods | Twelve‐week, randomised, double‐blind, multicentre, parallel‐group study. | |
Participants | Patients with a diagnosis of depression with associated anxiety, suitable for treatment with antidepressant, a Montgomery and Asberg Depression Rating Scale (MADRS) score of at least 20 and a Covi Anxiety Score (CAS) score of at least 11 could qualify for study entry. | |
Interventions | Paroxetine: 513 participants. Clomipramine: 503 participants. Paroxetine dose range: 20‐40 mg/day. Clomipramine dose range: 75‐150 mg/day. The only concurrent psychotropic medication permitted during active treatment was temazepam, up to 20 mg at night as a hypnotic, on an as‐needed basis. |
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Outcomes | MADRS, CAS, 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 | Only side effects occurring in >10% of patients. Funding: paroxetine manufacturer. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "patients were randomly assigned on the basis of a computer‐generated schedule in which treatments were balanced within blocks of consecutive patients to receive double blind treatment with either paroxetine or clomipramine for 12 weeks". |
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: "endpoint data were generated from the last available on‐treatment assessment for each patient. The endpoint for each analysis was taken as the visit at which at least 70% of the Intent‐to‐treat (ITT) population (randomized patient with at least one valid on‐treatment efficacy assessment) remained". More than 20% of participants in both arms withdrew from the study prematurely. |
Selective reporting (reporting bias) | Low risk | Outcomes data were reported. |
Other bias | Unclear risk | Sponsorship bias cannot be ruled out. |