the purpose of this study was to investigate the efficacy and safety of fixed dose combination ( fdc ) of olanzapine 5 mg and fluoxetine 20 mg in indian patients with severe or treatment resistant depression .
this was an open , non - comparative study of seven weeks duration with an initial placebo run in period of one week .
one hundred and forty - four patients completed the study as per protocol and 151 patients were safety evaluable .
one hundred and eleven patients ( 77% ) received one tablet of fdc of olanzapine 5 mg / fluoxetine 20 mg once daily for 6 weeks , in patients ( 14% ) , the dose was stepped up at the end of 2 weeks to 2 tablets of fdc of olanzapine 5 mg/ fluoxetine 20 mg once daily for a further 4 weeks and 13 patients ( 9% ) required dose to be stepped up at the end of 4 weeks to 3 tablets of fdc of olanzapine 5 mg and fluoxetine 20 mg once daily for last 2 weeks .
  one hundred and thirty four patients ( 93% ) responded to fdc of olanzapine and fluoxetine therapy ( a responder was defined as a patient with 50 % reduction over baseline in hdrs total score at the end of therapy).statistically significant ( p < 0.0001 ) reductions in hdrs total score , madrs total score and cgi severity scores were seen with olanzapine/ fluoxetine combination . 

one hundred and four patients ( 72% ) were remitters ( hdrs total score of < 7 ) after 6 weeks of therapy .
  treatment with fdc of olanzapine 5 mg / fluoxetine 20 mg was highly effective and well tolerated in indian patients with severe or treatment resistant depression .
 objective : the purpose of this study was to investigate the efficacy and safety of fixed dose combination ( fdc ) of olanzapine 5 mg and fluoxetine 20 mg in indian patients with severe or treatment resistant depression.design : this was an open , non - comparative study of seven weeks duration with an initial placebo run in period of one week.method : one hundred and fifty three patients were enrolled . 
 one hundred and forty - four patients completed the study as per protocol and 151 patients were safety evaluable . 
 one hundred and eleven patients ( 77% ) received one tablet of fdc of olanzapine 5 mg / fluoxetine 20 mg once daily for 6 weeks , in patients ( 14% ) , the dose was stepped up at the end of 2 weeks to 2 tablets of fdc of olanzapine 5 mg/ fluoxetine 20 mg once daily for a further 4 weeks and 13 patients ( 9% ) required dose to be stepped up at the end of 4 weeks to 3 tablets of fdc of olanzapine 5 mg and fluoxetine 20 mg once daily for last 2 weeks . 
 results : one hundred and thirty four patients ( 93% ) responded to fdc of olanzapine and fluoxetine therapy ( a responder was defined as a patient with 50 % reduction over baseline in hdrs total score at the end of therapy).statistically significant ( p < 0.0001 ) reductions in hdrs total score , madrs total score and cgi severity scores were seen with olanzapine/ fluoxetine combination . 
 
 one hundred and four patients ( 72% ) were remitters ( hdrs total score of < 7 ) after 6 weeks of therapy.adverse experiences were reported by thirty one patients ( 20.5% ) . 
 majority of them were mild in intensity . 
 no serious adverse event was recorded with study therapy . 
 three patients were withdrawn from the therapy due to adverse 
 event.conclusion : treatment with fdc of olanzapine 5 mg / fluoxetine 20 mg was highly effective and well tolerated in indian patients with severe or treatment resistant depression . 
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