title: 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.
  
  
  METHODS
  This was an open, non-comparative study of seven weeks duration with an initial placebo run in period of one week.
  
  
  METHODS
  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 Three patients were withdrawn from the therapy due to adverse event.
  
  
  CONCLUSIONS
  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.
authors.affiliation: R.M. HARIDAS, Prof. and Head, Dept of Psychiatry, Sir JJ Group of Hospitals, Mumbai.
authors.forename: R M
authors.initials: RM
authors.lastname: Haridas
authors.forename: S R
authors.initials: SR
authors.lastname: Parkar
authors.forename: Ram
authors.initials: R
authors.lastname: Ghulam
authors.forename: Gautam
authors.initials: G
authors.lastname: Amin
authors.forename: K G
authors.initials: KG
authors.lastname: Thombre
authors.forename: A
authors.initials: A
authors.lastname: Srivastava
authors.forename: N
authors.initials: N
authors.lastname: Bhuvaneshwari
authors.forename: S
authors.initials: S
authors.lastname: Telang
authors.forename: Monika
authors.initials: M
authors.lastname: Obrah
authors.forename: Nandkishore
authors.initials: N
authors.lastname: Toraskar
authors.forename: R K
authors.initials: RK
authors.lastname: Jalali
authors.forename: Kiran V
authors.initials: KV
authors.lastname: Marthak