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 .
A comparison of nefazodone and fluoxetine on mood and on objective, subjective, and clinician-rated measures of sleep in depressed patients: a double-blind, 8-week clinical trial.
BACKGROUND Previous small trials have suggested that nefazodone does not suppress rapid-eye-movement ( REM ) sleep or increase REM latency in depressed patients , in contrast to fluoxetine . The effects of nefazodone and fluoxetine on sleep architecture and on clinician- and patient-rated sleep measures were directly compared in this 8-week , multicenter , double-blind , r and omized , parallel-group study . METHOD Forty-four out patients with moderate to severe , nonpsychotic major depressive disorder ( DSM-III-R ) and insomnia were r and omly assigned to receive nefazodone ( Days 1 - 7 , 200 mg/day ; Days 8 - 56 , 400 mg/day ) or fluoxetine ( Days 1 - 56 , 20 mg/day ) . Sleep measures were obtained at baseline , while patients were unmedicated , and at Weeks 2 , 4 , and 8 of treatment . RESULTS In 43 evaluable patients ( 23 nefazodone , 20 fluoxetine ) , nefazodone and fluoxetine demonstrated similar antidepressant efficacy . All significant values were p < .05 . Fluoxetine significantly decreased sleep efficiency and REM sleep and increased number of awakenings , Stage 1 sleep , and REM latency compared with baseline . In contrast , nefazodone significantly decreased percentage of awake and movement time and did not alter sleep efficiency or number of awakenings , Stage 1 or REM sleep , or REM latency compared with baseline . Nefazodone was associated with significantly less change from baseline for sleep efficiency , number of awakenings , percentage of awake and movement time , percentage of REM and Stage 1 sleep , and REM latency compared with fluoxetine . Both fluoxetine- and nefazodone-treated patients also showed significant improvement in some clinician- and patient-rated sleep disturbance scores , but nefazodone-treated patients improved to a significantly greater extent than fluoxetine-treated patients in most measures . CONCLUSION While nefazodone and fluoxetine showed equivalent antidepressant efficacy , more objective , subjective , and clinician-rated measures of sleep disturbance were improved during treatment with nefazodone than with fluoxetine . These results suggest that antidepressant effects of medications can occur independently of drug-induced changes in objective , subjective , and clinician-rated measures of sleep . Further studies , including parallel placebo-controlled comparisons with nefazodone , are needed to further test this hypothesis
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 .