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|Year : 2003 | Volume
| Issue : 4 | Page : 234-238
Olanzapine and Fluoxetine Combination In Severe or Resistant Depression
RM Haridas1, SR Parkar2, Ram Ghulam3, Gautam Amin4, KG Thombre5, A Srivastava6, N Bhuvaneshwari7, S Telang8, Monika Obrah9, Nandkishore Toraskar10, RK Jalali11, Kiran V Marthak11
1 Prof, and Head, Dept of Psychiatry, Sir JJ Group of Hospitals, Mumbai, India
2 Prof, and Head, Dept. of Psychiatry, Seth GS Medical College and KEM Hospital, Mumbai, India
3 Associated Professor and Head, Dept. of Psychiatry and Superintendent, Mahatma Gandhi Medical College, Indore, India
4 Consultant Psychiatrist and Psychotherapist, Dr. Contractor's Hospital, Vadodara, India
5 Consultant Psychiatrist, Ramprasad Chambers, Nana Peth, Pune, India
6 Asst. Prof. of Psychiatry, Deccan College of Medical Sciences and Owaisi Hospital.and Research Centre, Hyderabad, India
7 Prof., of Psychiatry, Gandhi Hospital, Secunderabad, India
8 Consultant Psychiatrist, Jehangir Hospital and Medical Centre, Pune, India
9 Clinical Research Associate, MACR, Ranbaxy Laboratories Ltd, India
10 Senior Research Scientist, Clinical Data Management, Ranbaxy Laboratories Ltd, India
11 MACR, Ranbaxy Laboratories Ltd, India
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.
R M Haridas
Prof, and Head, Dept of Psychiatry, Sir JJ Group of Hospitals, Mumbai
Source of Support: None, Conflict of Interest: None