Efficacy and tolerability of controlled-release trazodone in depression: a large multicentre study in general...

A double-blind, parallel-group study was carried out to compare the efficacy and tolerability of a controlled-release tablet formulation of trazodone with the standard trazodone tablet. Three hundred and forty-seven general practice patients with depressive symptoms were recruited into the trial. Patients were randomly allocated to receive either 1 controlled-release trazodone (150 mg) tablet at night or 1 standard trazodone (150 mg) tablet at night for a period of 6 weeks. Assessments of efficacy, tolerability and compliance were made at study entry and after 1, 2, 4 and 6 weeks of study medication. Seventy-seven patients withdrew from the study of whom 44 were in the standard trazodone tablet group and 33 were in the controlled-release trazodone tablet group. There were no statistically significant differences between treatment groups in any of the measures of efficacy (global severity, global improvement and Hamilton Depression Rating Scales 17- and 21-item). Major improvements in patients' condition were shown in all efficacy measures by the end of the study in comparison with study entry. Treatment differences were small but were numerically in favour of the controlled-release tablet formulation. As expected, a greater proportion of side-effects were reported during the first 2 weeks of treatment in both groups. Treatment differences, revealed in a five symptom adverse event checklist used throughout the study, were small, although in favour of the controlled-release tablet in the majority of cases, but not statistically significant.