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 mianserin and fluoxetine in ambulatory therapy of depressed patients].
A double blind controlled trial was carried out in 65 depressed out- patients to compare the efficacy and tolerance of mianserin with fluoxetine . The two compounds present very different pharmacological activities . Mianserin is an antagonist of the alpha 2-adrenergic receptors , while fluoxetine is an inhibitor of recapture specific to serotonin . Requirements for inclusion were : depressive episode of less than 2 months duration , meeting the criteria for one of the sub-types of depression described in DSM III , with a minimum score of 25 on the Montgomery Asberg Depressive Rating Scale ( MADRS ) . The patient 's ages ranged from 18 to 65 . The only psychotropic medication allowed in association to the treatment was prazepam ( up to 40 mg/day ) . Patients gave their written consent to the study . Assessment , using the Montgomery Asberg Depression Rating Scale ( MADRS ) , the HARD diagram , the check list for somatic symptoms and side-effects was carried out before treatment and at the end of weeks 2 , 4 , 8 . Assessment of anxiety using the Hamilton Anxiety Rating Scale ( HARS ) and of sleep disturbances using a sleep question naire was carried out before treatment and at week 4 . The 8 items of the sleep question naire covers the complaints listed in criteria for insomnia disorders ( 307.42 DSM III-R ) . Clinical Global Impression ( CGI ) , Therapeutic Index ( TI ) , Tolerance Global Impression were assessed at end-point . The 2 groups were strictly comparable in respect to the clinical status at base line ( diagnosis , history and duration of the depressive illness , MADRS and HARD diagram scores ) . ( ABSTRACT TRUNCATED AT 250 WORDS
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 .