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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 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.
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 Three patients were withdrawn from the therapy due to adverse event.
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.