Ziprasidone in the Treatment of Borderline Personality Disorder

Borderline Personality Disorder Clinical Trial

Official title:

Ziprasidone in the Treatment of Borderline Personality Disorder: A Double-Blind, Placebo-Controlled, Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00635921
• Other study ID #: HSP-2003-002
• Secondary ID: HSP-2003-002
• Status: Completed
• Phase: Phase 2
• First received: March 11, 2008
• Last updated: March 11, 2008
• Start date: March 2004
• Est. completion date: April 2006

Study information

• Verified date: March 2008
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Disease
• Personality Disorders

Intervention

Drug:
• ziprasidone
Dose flexible from 40 to 200 mg/d during 12 weeks
• Placebo
flexible doses from 40 to 200 mg/d during 12 weeks

Locations

Country	Name	City	State
Spain	Department of Psychiatry, Sta. Creu and St. Pau Hospital	Barcelona.

Sponsors (4)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Ministry of Health, Spain, Pfizer, REM-TAP Network

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CGI scale for use in borderline personality disorder (CGI-BPD)		12 weeks
Secondary	Hamilton Rating Scale Depression (HAM-D-17)		12 weeks
Secondary	Hamilton Rating Scale for Anxiety (HAM-A)		12 weeks
Secondary	Brief Psychiatric Rating Scale (BPRS)		12 weeks
Secondary	SCL-90-R		12 weeks
Secondary	Barratt Impulsiveness Scale		12 weeks
Secondary	Treatment-emergent adverse events		12 weeks
Secondary	UKU Side Effect Rating Scale		12 weeks
Secondary	EKG and laboratory assessment		12 weeks
Secondary	Buss-Durkee Inventory		12 weeks