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Title: Is Flunarizine a Long-Acting Oral Atypical Antipsychotic? A Randomized Clinical Trial Versus Haloperidol for the Treatment of Schizophrenia
Authors: Bisol, Luisa W.
Brunstein, Miriam G.
Ottoni, Gustavo L.
Ramos, Fernanda L. P.
Borba, Daniela L.
Daltio, Claudiane Salles [UNIFESP]
Oliveira, Ricardo V. de
Paz, Gisele E. G.
Souza, Sayuri E. de [UNIFESP]
Bressan, Rodrigo Affonseca [UNIFESP]
Lara, Diogo R.
Univ Fed Rio Grande do Sul
Hosp Clin
Pontificia Univ Rio Grande Sul
Universidade Federal de São Paulo (UNIFESP)
Issue Date: 1-Oct-2008
Publisher: Physicians Postgraduate Press
Citation: Journal Of Clinical Psychiatry. Memphis: Physicians Postgraduate Press, v. 69, n. 10, p. 1572-1579, 2008.
Abstract: Background: Flunarizine is known as a nonspecific calcium channel blocker that has been used for decades for the treatment of migraine, vertigo. and cognitive deficits related to cerebrovascular disorders. Flunarizine also has dopamine D-2 receptor blocking properties and was effective in animal models of predictive validity for antipsychotics. However, its clinical antipsychotic efficacy has never been investigated.Objective: To evaluate the therapeutic efficacy and tolerability of flunarizine compared to haloperidol in outpatients with stable and chronic DSM-IV-defined schizophrenia and schizo-affective disorder.Method: Seventy patients from 2 centers were randomly assigned and participated in a double-blind, parallel-group, flexible-dose study comparing flunarizine (10-50 mg/day) and haloperidol (2.5-12.5 mg/day) for 12 weeks. Patients were assessed with the Positive and Negative Syndrome Scale (PANSS), the Clinical Global Impressions-Improvement (CGI-I) scale, the Extrapyramidal Symptom Rating Scale (ESRS), a battery for cognitive performance, and laboratory examinations. The study was conducted from September 2004 to May 2007.Results: Mean doses at endpoint were 29.7 mg/day for flunarizine and 6.4 mg/day for haloperidol. Both groups showed significant symptom improvement during the study, with a reduction of 21% in the flunarizine group and 19% in the haloperidol group in PANSS total scores (p < .05). There were no significant differences in PANSS overall score and all subscales, CGI-I score, or cognitive performance. Dropout rates, ESRS scores, and prolactin levels were not different between groups, but significantly more patients reported emergence of akathisia in the haloperidol group (p = .04), and weight gain was significantly higher with flunarizine (1.2 kg) than with haloperidol (-0.8 kg) (p < .05).Conclusion: This is the first study evaluating the antipsychotic properties of flunarizine, which showed good efficacy and tolerability for the treatment of schizophrenia, with a possible atypical profile. Its unique pharmacokinetic profile as an oral drug with long half-life (2-7 weeks), low cost, and low induction of extrapyramidal symptoms warrants further investigation, particularly in psychiatric patients with low adherence to treatment.Trial Registration: Identifier: NCT00740259 (J Clin Psychiatry 2008;69:1572-1579)
ISSN: 0160-6689
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