Conclusions : International differences in prescriber behaviour may influence , and in turn be influenced by , the conduct of clinical trials .
Objective : International differences are thought to exist in dosages used by clinicians treating mood disorders .
This study examined international dosage differences in antidepressant clinical trials , using a data base formed and maintained as a component of a Cochrane review of comparative clinical trials of fluoxetine .
Double‐blind study of the efficacy and safety of sertraline versus fluoxetine in major depression
An eight-week double-blind , multicentre study was performed to evaluate the efficacy and safety of sertraline vs. fluoxetine in the treatment of major depression ( DSM-III-R ) . There were 108 out- patients , from nine Italian centres , entered into the study , of whom 88 were evaluable ( 48 sertraline , 40 fluoxetine ) . The final mean daily dose of sertraline was 72 mg and for fluoxetine it was 28 mg . Both treatment groups showed a statistically significant improvement from baseline at one week , and this was maintained until the end of treatment for all of the following measures : Hamilton Rating Scales for Depression and Anxiety , the Montgomery Asberg Depression Rating Scale , Clinical Global Impressions Scale , Zung Self-Rating Scale for Anxiety and the Leeds Sleep Evaluation Question naire . Although there was a numerical advantage for sertraline on several efficacy measures , there was no statistically significant difference found between the treatment groups . The incidence of adverse events was similar for both treatments ; 40.4 % for sertraline and 39.3 % for fluoxetine . However , adverse events were generally rated by patients as of lower severity in the sertraline group . In addition , for the fluoxetine group , there was a higher incidence of agitation , anxiety and insomnia than for sertraline . Sertraline was considered to be better tolerated than fluoxetine overall , since only 9.6 % of sertraline-treated patients discontinued treatment due to therapy failure whereas in the fluoxetine-treated group this figure was 19.6 % . By contrast , 13.5 % of sertraline-treated patients discontinued prematurely because of clinical improvement , compared with 10.7 % of fluoxetine-treated patients
Conclusions : International differences in prescriber behaviour may influence , and in turn be influenced by , the conduct of clinical trials .
Objective : International differences are thought to exist in dosages used by clinicians treating mood disorders .
This study examined international dosage differences in antidepressant clinical trials , using a data base formed and maintained as a component of a Cochrane review of comparative clinical trials of fluoxetine .