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Indian J Psychiatry. 2003 Oct-Dec; 45(4): 234–238.
PMCID: PMC2952370

Olanzapine and fluoxetine combination in severe or resistant depression

Abstract

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 Three patients were withdrawn from the therapy due to adverse event.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

Keywords: Olanzapine, Fluoxetine, Severe depression

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Selected References

These references are in PubMed. This may not be the complete list of references from this article.
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