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Background and Objectives: Previous data from safety analysis indicatethat olanzapine can result in substantial weight gain, while no change has been observedwith ziprasidone. Obesity may be a threat to health and cause subjects to discontinue theirantipsychotic medication. To further evaluate the differential effects of ziprasidone andolanzapine on weight gain, a study was carried out having body weight as the primary efficacyendpoint.Methods: A six-month randomized, double-blind, parallel study was carried out inmale and female subjects aged 18-70 years with a primary diagnosis of schizophrenia(DSM-IV-TR) and a clinical condition requiring treatment initiation with a new antipsychotic,ziprasidone or olanzapine 1:1, to assess treatment-related weight changes. Fiftypatients were included. Efficacy outcomes were assessed at baseline and at weeks 1, 4, 12,18 and 24. The primary efficacy endpoint was the percent change from baseline in bodyweight at week 24. Safety was also assessed.Results: At week 24, there was a significantly greater increase in body weight (7.5%,p < 0.0001) in patients treated with olanzapine than in those treated with ziprasidone and number of subjects who had a weight gain . 7% was significantly higher in the olanzapinecompared to the ziprasidone group (n = 11 [47.8%]) vs n = 3 [11.1%]; OR = 6.246,p-value = 0.0150). PANNS-N significantly decreased in both groups. Most AEs weremoderate or mild in both groups.Conclusions: Olanzapine increases body weight significantly over ziprasidone at week24. However, treatment with either ziprasidone or olanzapine improved PANSS positive,negative and general psychopathology scores and was well tolerated.

the european journal of psychiatry

Ziprasidone versus Olanzapine in the weight gain associated with the treatment of schizophrenia: A six-month double-blind randomized parallel group study