Ziprasidone in the treatment of borderline personality disorder: a double-blind, placebo-controlled, randomized study.
Author(s): Pascual JC, Soler J, Puigdemont D, Perez-Egea R, Tiana T, Alvarez E, Perez V
Affiliation(s): Department of Psychiatry, Sta. Creu and St. Pau Hospital, Barcelona, Spain.
Publication date & source: 2008-04, J Clin Psychiatry., 69(4):603-8.
Publication type: Randomized Controlled Trial; Research Support, Non-U.S. Gov't
OBJECTIVE: The aim of this double-blind, placebo-controlled study was to evaluate the efficacy and tolerability of ziprasidone in the treatment of adult patients with borderline personality disorder. METHOD: Sixty DSM-IV borderline personality disorder patients were included from March 2004 to April 2006 in a 12-week, single-center, double-blind, placebo-controlled study. The subjects were randomly assigned to ziprasidone or placebo in a 1:1 ratio following a 2-week baseline period. The Clinical Global Impressions scale for use in borderline personality disorder patients (CGI-BPD) was the primary outcome measure, and other scales and self-reports related to affect, behavior, psychosis, general psychopathology domains, and clinical safety were included. RESULTS: Analysis of variance indicated no statistically significant differences between ziprasidone and placebo in the CGI-BPD. Nor were significant differences observed between groups in depressive, anxiety, psychotic, or impulsive symptoms. The mean daily dose of ziprasidone was 84.1 mg/day (SD = 54.8; range, 40-200). The drug was seen to be safe, and no serious adverse effects were observed. CONCLUSION: This trial failed to show a significant effect of ziprasidone in patients with borderline personality disorder. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00635921.