Ziprasidone in the treatment of borderline personality disorder: a double-blind, placebo-controlled, randomized study.
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.


METHODS
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.


CONCLUSIONS
This trial failed to show a significant effect of ziprasidone in patients with borderline personality disorder.


BACKGROUND
clinicaltrials.gov Identifier: NCT00635921.
Pascual
Juan Carlos
JC
Department of Psychiatry, Sta. Creu and St. Pau Hospital, Barcelona, Spain.
Soler
Joaquim
J
Puigdemont
Dolors
D
Pérez-Egea
Rosario
R
Tiana
Thais
T
Alvarez
Enrique
E
Pérez
Víctor
V
D000293:Adolescent; D000328:Adult; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000175:diagnosis / Q000453:epidemiology; D001883:Borderline Personality Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D015897:Comorbidity; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000453:epidemiology; D007174:Disruptive, Impulse Control, and Conduct Disorders / Q000175:diagnosis / Q000453:epidemiology; D004311:Double-Blind Method; D006801:Humans; D008875:Middle Aged; D019965:Neurocognitive Disorders / Q000453:epidemiology; D010879:Piperazines / Q000627:therapeutic use*; D011605:Psychoses, Substance-Induced / Q000175:diagnosis / Q000453:epidemiology; D012559:Schizophrenia / Q000175:diagnosis / Q000453:epidemiology; D019966:Substance-Related Disorders / Q000175:diagnosis / Q000453:epidemiology; D011795:Surveys and Questionnaires; D013844:Thiazoles / Q000627:therapeutic use*
D014150:Antipsychotic Agents; D010879:Piperazines; D013844:Thiazoles; C092292:ziprasidone