OLANZAPINE IN PUERTO RICAN OUTPATIENTS WITH BIPOLAR ... Objective: To assess the efficacy of olanzapine/fluoxetine combination (OFC) in patients ...
EFFICACY & SAFETY OF THE COMBINATION OF FLUOXETINE AND OLANZAPINE IN PUERTO RICAN OUTPATIENTS WITH BIPOLAR DEPRESSION: A TWO-PHASE OPEN LABEL RANDOMIZED MULTICENTER STUDY Jorge M. Tamayo1, Virginia K. Sutton2, Manuel A. Mattei2, Barbara Diaz3, Hassan H. Jamal2, E Vieta4, Carlos Zarate5, Ileana Fumero6, Mauricio Tohen2,7 1CES University, Medellín, Colombia & University of Puerto Rico, San Juan Puerto Rico; 2Lilly Research Laboratories, USA; 3Ashford Medical Center, Puerto Rico; 4University of Barcelona Hospital Clinic, Spain, 5National Institute of Mental Health, USA, 6POBOX 19234 Fernandez Juncos Station, San Juan, Puerto Rico; 7Harvard Medical School, USA.
HGMA Poster Outline Draft 24 Jan 2007- H Jamal
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ABSTRACT Objective: To assess the efficacy of olanzapine/fluoxetine combination (OFC) in patients with Bipolar Depression (BD) as measured by the Montgomery-Åsberg Depression Rating Scale total score (MADRS) (study period I [SPI]), and the maintenance of response with OFC or olanzapine monotherapy (OLZ) (study period II [SPII]). Method: Puerto Rican outpatients received open-label OFC at doses of 12 mg/25 mg (range 6/25-12/50) for 7 weeks in SPI and responders were then randomized to OFC at their last dose from SPI or OLZ 10 mg (range 5-20) for an additional 12 weeks in SPII. Secondary measures included Clinical Global Impressions of Severity of Depression (CGI-BP-D), the Medical Outcomes Study 12-Item Short Form Health Survey (SF-12) and safety parameters. Result: SPI: n=161; SPII entered/completed: OFC n=57/44, OLZ n=57/39. MADRS improved for OFC during SPI (-20, p
