Clinical trial NCT00635921: Ziprasidone in the Treatment of Borderline Personality Disorder
Official title: Ziprasidone in the Treatment of Borderline Personality Disorder: A Double-Blind, Placebo-Controlled, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Borderline Personality Disorder
Keywords: Borderline Personality Disorder
ziprasidone
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Spain
name: REM-TAP Network
name: Pfizer
First posted: 2008-03-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 (BPD).

Method: Sixty BPD patients were included 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 two-week baseline period. The Clinical Global Impression scale for use in BPD 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.

Detailed description: The American Psychiatric Association (APA) Guidelines for the Treatment of Borderline personality disorder recommend that pharmacological treatment for BPD has an important adjunctive role, especially for diminution of symptoms such as affective instability, impulsivity, psychotic-like symptoms, and self-destructive behavior. Studies conducted with low doses of conventional antipsychotics have showed significant improvements in specific symptoms such as hostility, impulsiveness, mood, and psychotic symptoms.

The introduction of atypical antipsychotics, with a more favorable tolerance profile, increases clinicians' options for treating BPD. Olanzapine has proven its efficacy in four double-blind, placebo-controlled clinical trials in patients with BPD. Ziprasidone is an atypical antipsychotic with a pharmacological action on serotonergic, dopaminergic and adrenergic receptors. It has proven to be effective for schizophrenia, schizoaffective and acute mania disorders and the incidence of side effects is low.

Although clinical findings and the pharmacological activity of ziprasidone suggest the drug may have therapeutic benefits in BPD patients, no controlled studies have yet been conducted in these patients. We carried out a randomized, double-blind, placebo-controlled study to evaluate efficacy and tolerability of ziprasidone in the management of BPD patients with moderate-high clinical severity.

Eligibility criteria: Inclusion Criteria:

* DSM-IV diagnosis of Borderline Personality Disorder
* Age between 18 and 45 years
* Clinical Global Impression of Severity (CGI-S)scores \>4

Exclusion Criteria:

* No comorbidity with schizophrenia, drug-induced psychosis, organic brain syndrome, alcohol or other substance dependence, bipolar disorder, mental retardation, or major depressive episode in course
* current use of medically accepted contraception in the case of female patients.

Primary outcomes:
measure: CGI scale for use in borderline personality disorder (CGI-BPD)
timeFrame: 12 weeks
Secondary outcomes:
measure: Hamilton Rating Scale Depression (HAM-D-17)
timeFrame: 12 weeks
measure: Hamilton Rating Scale for Anxiety (HAM-A)
timeFrame: 12 weeks
measure: Brief Psychiatric Rating Scale (BPRS)
timeFrame: 12 weeks
measure: SCL-90-R
timeFrame: 12 weeks
measure: Barratt Impulsiveness Scale
timeFrame: 12 weeks
measure: Treatment-emergent adverse events
timeFrame: 12 weeks
measure: UKU Side Effect Rating Scale
timeFrame: 12 weeks
measure: EKG and laboratory assessment
timeFrame: 12 weeks
measure: Buss-Durkee Inventory
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Barcelona.
country: Spain
facility: Department of Psychiatry, Sta. Creu and St. Pau Hospital
Study officials:
References:
citation: Stoffers-Winterling JM, Storebo OJ, Pereira Ribeiro J, Kongerslev MT, Vollm BA, Mattivi JT, Faltinsen E, Todorovac A, Jorgensen MS, Callesen HE, Sales CP, Schaug JP, Simonsen E, Lieb K. Pharmacological interventions for people with borderline personality disorder. Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD012956. doi: 10.1002/14651858.CD012956.pub2.
citation: Pascual JC, Soler J, Puigdemont D, Perez-Egea R, Tiana T, Alvarez E, Perez V. Ziprasidone in the treatment of borderline personality disorder: a double-blind, placebo-controlled, randomized study. J Clin Psychiatry. 2008 Apr;69(4):603-8. doi: 10.4088/jcp.v69n0412.