A 6-month prospective, observational, naturalistic, uncontrolled study to evaluate the effectiveness and tolerability of oral ziprasidone in patients with schizophrenia.

作者: C Arango , M Gómez-Beneyto , J Brenlla , C Gastó , F Sarramea-Crespo

DOI: 10.1016/J.EURONEURO.2006.11.007

关键词: Uncontrolled StudyAdverse effectZiprasidoneInternal medicinePsychiatrySomnolenceClinical trialDiscontinuationLower riskTolerabilityPsychology

摘要: This multicenter, uncontrolled, naturalistic study evaluated the effectiveness and tolerability of 6 months treatment with ziprasidone in 1266 patients a diagnosis schizophrenia. The percentage responders (at least 30% reduction PANSS total score) primary analysis sample (n=1022) was 47.3% (95% CI 44.2-50.4) at end study. Patients showed significant clinically relevant total, positive, negative general psychopathology subscales scores (effect size 1.60, 1.83, 0.62 1.40 respectively). Overall, 453 (35.8%) withdrew from study; 9.3% owing to adverse events. Ziprasidone doses greater than 120 mg/day were associated lower risk discontinuation for any cause (OR 0.46, 95% 0.33-0.65) well tolerated. Most common side effects were: insomnia, somnolence nervousness. clinical practice are consistent those previously shown more restricted homogeneous populations trials.

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