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. 2014 Apr 3;2014(4):CD006531. doi: 10.1002/14651858.CD006531.pub2

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.
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.
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.